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This breakthrough drug trial saw cancer vanish in every patient – Euronews

Posted: June 13, 2022 at 2:42 am

More than a dozen rectal cancer patients in the United States have seen their cancer disappear after undergoing experimental immunotherapy, in what doctors are calling an astonishing result.

The patients, who were part of a small clinical trial led by researchers from New Yorks Memorial Sloan Kettering (MSK) Cancer Center, saw their tumours vanish after being treated with an experimental drug called dostarlimab.

Details of the trial were published on Sunday in the New England Journal of Medicine.

The paper described the results of 12 patients with rectal cancer, all of whom saw their cancer vanish after treatment with dostarlimab.

Participants received a dose of dostarlimab every three weeks for six months, with the idea being that they would need to undergo standard treatments of chemotherapy, radiation therapy and surgery following treatment.

However, researchers found that in every case, the cancer was cleared through the experimental treatment alone.

The trial has been hailed as a first in cancer treatment, with one of the papers authors, Dr Luis Diaz Jr of Memorial Sloan Kettering, telling the New York Times that he knew of no other study in which a treatment completely obliterated a cancer in every patient.

I believe this is the first time this has happened in the history of cancer, he said.

Immunotherapy harnesses the bodys own immune system to identify and destroy cancer cells.

The trial focussed on a subset of rectal cancer patients whose cancer had a specific mutation, MSK said in a statement.

This sort of rectal cancer, known as "mismatch repair-deficient" (MMRd) rectal cancer, tends to respond poorly to standard chemotherapy regimens. In the trial, researchers wanted to investigate if immunotherapy alone could beat rectal cancer that had not spread to other tissues, the organisation said.

The research, which is ongoing, has seen at least 14 patients and counting have their tumours disappear, with none of them experiencing significant side effects, it added.

There was no need for standard treatments of radiation, surgery, or chemotherapy, and the cancer has not returned in any of the patients, who have been cancer-free for up to two years, it said.

Its incredibly rewarding to get these happy tears and happy emails from the patients in this study who finish treatment and realise, Oh my God, I get to keep all my normal body functions that I feared I might lose to radiation or surgery, said Dr Andrea Cercek of Memorial Sloan Kettering, who co-led the trial.

Inspiration for the study came from a previous trial led by Dr Diaz, which saw patients taking a drug called pembrolizumab, the New York Times reported. That trial, which involved patients with advanced cancer that resisted standard treatment, saw participants tumours stabilise, shrink and even vanish.

In the current trial, researchers wanted to see what a similar drug, dostarlimab, would do if used before the cancer cells had a chance to spread.

This sort of treatment focuses on particular proteins called checkpoints, which are made by some types of immune system cells as well as some cancer cells, according to the USNational Cancer Institute. The checkpoints, which keep immune responses from being too strong, can sometimes prevent immune cells from effectively killing cancer cells.

Like pembrolizumab, dostarlimab is a checkpoint inhibitor: It essentially releases the brakes on an immune cell, freeing it to recognise and attack cancer cells, according to MSK.

When the brakes are taken off the immune cells, MMRd cells look especially strange because they have so many mutations. So the immune cells attack with much more force, Dr Cercek said.

The results have provided what may be an early glimpse of a revolutionary treatment shift, Dr Hanna Sanoff, an oncologist at the Lineberger Comprehensive Cancer Center at the University of North Carolina, who was not involved in the trial, wrote in an editorial accompanying the paper.

However, she added that although the results are cause for great optimism, such an approach cannot yet supplant our current curative treatment approach.

Whether the results of this small study conducted at Memorial Sloan Kettering Cancer Center will be generalisable to a broader population of patients with rectal cancer is also not known, she said.

In order to provide more information regarding which patients might benefit from immunotherapy, subsequent trials should aim for heterogeneity in age, coexisting conditions, and tumour bulk.

The clinical trial is continuing to enrol patients and is growing, the MSK researchers said. They are also investigating to see if the same method can beat other cancers, and are looking at patients with gastric (stomach), prostate, and pancreatic cancers.

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Long-term Treatment With Luspatercept Reduces Transfusion Dependence Associated With -Thalassemia – OncLive

Posted: June 13, 2022 at 2:42 am

The longest duration of reduction in red blood cell transfusion dependence was reported among patients with -thalassemia who received continued treatment with luspatercept-aamt in the updated data from the phase 3 BELIEVE trial.

The longest duration of reduction in red blood cell (RBC) transfusion dependence was reported among patients with -thalassemia who received continued treatment with luspatercept-aamt (Reblozyl) in the updated data from the phase 3 BELIEVE trial (NCT02604433), presented at the 2022 EHA Congress.1

Response was assessed as reduction of RBC transfusion burden by at least 33% from baseline and by at least 50% from baseline among patients who received luspatercept vs placebo during any rolling 12- or 24-week interval. With a long-term data cutoff of January 5, 2021, among the 224 patients in the luspatercept arm, 173 patients (77.2%) had at least 33% response during any 12-week interval and 116 (51.8%) had a response during any 24-week interval. A transfusion burden reduction of at least 50% was reported among 112 patients (50%) and 53 patients (23.7%) during any 12- and 24-week interval, respectively.1

These outcomes were compared with prior data cutoff landmarks: May 11, 2018 (primary data cutoff) and January 7, 2019 (intermediate data cutoff). In the primary analysis, 70.5% and 41.1% of patients had at least a 33% reduction in transfusion burden at the 12- and 24-week intervals. These rates were 76.3% and 45.1% in the intermediate analysis, respectively. Reduction of at least 50% were reported at any 12- and 24-week intervals among 40.2% and 16.5% of patients, respectively, in the primary analysis and 44.6% and 20.5% in the intermediate analysis.1

In terms of transfusion independence, at the cutoff of 3 years 12% of patients [who received] luspatercept, achieved transfusion independence, equal to or more than [8] weeks. And that, of course, implies the longest interval of this condition of transfusion in dependence, said Maria Domenica Cappellini, MD, FRCP, FACP, professor of internal medicine at the University of Milan and chief of the Rare Diseases Centre at the Fondazione IRCCS Policlinico Hospital in Italy, during a presentation of the data.

The median longest duration of RBC transfusion independence was 72 days (95% CI, 62-103) with longer-term luspatercept treatment. At the primary and intermediate analysis cutoffs, the rates of RBC transfusion independence lasting at least 8 weeks were 10.7% and 11.2%, respectively, compared with 12.1% in the longer-term analysis.

Continuous treatment with the luspatercept allowed for more patients to experience a reduction in RBC transfusion burden, with longer durations of responses compared [with] the previous cutoff, Cappellini said. We are confident that these [benefits] will be even more clear with longer follow-up and patients with transfusion dependent -thalassemia treated in the BELIEVE study will continue to benefit from luspatercept with over 3 years of treatment.

Additional data showed that the median duration of RBC transfusion burden reduction was 114 days (95% CI, 107-137) and 99 days (95% CI, 95-104) for those with 33% reduction and 50% reduction, respectively, at the long-term analysis cutoff. In the primary data cutoff analysis, the median duration of RBC transfusion burden reduction was 104 days (95% CI, 84-588) for those with at least 33% reduction and 97.5 days (95% CI, 84-588) for those with at least 50% reduction. In the intermediate analysis the median duration was 105 days (95% CI, 84-825) and 99 days (95% CI, 84-825), respectively.

The median treatment duration during the primary, intermediate, and long-term landmark analyses were 64.1 days (95% CI, 3-97), 95.7 days (95% CI, 1.7-128.1), and 153.6 days (95% CI, 1.7-215).

Further, the mean cumulative duration of RBC transfusion burden reduction during any rolling 12-week interval was 627.3 (standard deviation, 390.5) for patients who received luspatercept.1

In terms of RBC transfusion burden change from baseline, Cappellini noted that patients receiving luspatercept required fewer units of blood over time. The mean change in RBC units every 48 weeks from baseline was 4.8 (weeks 1-48), 5.6 (weeks 49-96), 6.2 (weeks 97-144), and 6.4 (weeks 145-192) compared with a 1.1 unit increase reported in weeks 1-48 with placebo.

Cappellini also highlighted that patients achieving an RBC transfusion burden reduction of 50% or higher experienced a greater interval between the transfusions compared with the baseline over time at a mean of +9.9 days (standard deviation, 22.0).1

Luspatercept, an erthyroid maturation agent, is approved for the treatment of anemia in patients with -thalassemia who require regular red blood cell (RBC) transfusions. Additionally, it received an indication for patients who require 2 or more RBC units over 8 weeks for patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts or with MDS/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.2

BELIEVE was a randomized, double-blind, study comparing luspatercept with placebo.1,3 Investigators enrolled adults with -thalassemia who required regular transfusions of 6 to 20 RBC units in the 24 weeks prior to random assignment, with no transfusion-free period (35 days). Patients were randomly assigned 2:1 to luspatercept (n = 224) plus best supportive care or placebo plus best supportive care (n = 112). Luspatercept was administered subcutaneously 1.0 mg/kg (up to a maximum dose of 1.25 mg/kg) every 3 weeks. Best supportive care included RBC transfusions to maintain baseline hemoglobin levels and iron chelation therapy.1,3

The primary end point was reduction of RBC transfusion burden by at least 33% from baseline with a reduction of at least 2 units in weeks 13 to 24 compared with the 12 weeks prior to randomization.3

Baseline characteristics between the experimental and control arm were well balanced. The median age was 30 years (range, 18-66). Median hemoglobin levels at 24 weeks were 9.31 g/dL (range, 4.5-11.4) and 9.15 g/dL (range, 5.8-11.7) in the luspatercept arm and placebo arm, respectively. The median RBC transfusion burden was 6.12 units (range, 3-14) every 12 weeks in the luspatercept arm and 6.27 (range, 3-12) in the placebo arm. The median burden every 24 weeks was 14 units (range, 6-24) and 15 (range, 6-26), respectively. Further, over half of patients (57.6% and 58.0%, respectively) had a splenectomy.

In terms of liver iron concentration (LIC), at baseline the median LIC in the luspatercept arm was 6.4 mg/g dry weight (range, 0.8-125.0) and 5.05 mg/g dry weight (range, 0.2-53.2) in the placebo arm. An analysis of LIC is ongoing, according to Cappellini.

At data cutoff 127 patients (56.7%) remained on study treatment and 2.7% (n = 6) have completed 192 weeks of treatment. Of the 224 patients in the luspatercept arm, 96 (42.9%) discontinued treatment. The most common reasons for discontinuation were physician decision (23.7%), adverse event (10.3%), or other (5.4%).

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Vertex to Present Data Demonstrating Significant Benefits of Long-Term and Early Treatment With CFTR Modulators at the European Cystic Fibrosis…

Posted: June 13, 2022 at 2:42 am

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that five scientific abstracts on the companys portfolio of cystic fibrosis (CF) medicines will be presented at the European Cystic Fibrosis Society's (ECFS) 45th European Cystic Fibrosis Conference held June 8-11, 2022, in Rotterdam, the Netherlands.

Vertex will present the first analysis of data collected in the U.S. CF Foundation Patient Registry (CFFPR) of over 16,000 people with CF treated with TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for an average of nine months. This first interim analysis of an ongoing five-year post-authorization study (abstract WS22.05) showed that real-world treatment with TRIKAFTA was associated with improved lung function and a 77% reduced risk of pulmonary exacerbations compared to pre-TRIKAFTA baseline, as well as an 87% lower risk of lung transplant and a 74% lower risk of death, compared to the historical 2019 U.S. CFFPR population. No new safety concerns were identified.

Vertex will also present data comparing the annual rate of lung function change in people with CF ages 12 years and older with two F508del mutations (F/F) or one F508del mutation and one minimal function mutation (F/MF) treated with TRIKAFTA in pivotal studies and an open-label extension study compared to propensity-score matched historical CFTR-modulator-untreated controls from the U.S. CFFPR (abstract WS22.04). Results show that TRIKAFTA demonstrated on average no decrease in ppFEV1 over a two-year period in this population, in contrast to declines seen in the matched controls. The analysis indicates that treatment with TRIKAFTA has a significant impact on the trajectory of CF lung disease.

Additionally, Vertex will present data from a long-term real-world study demonstrating that initiating KALYDECO (ivacaftor) early in life (ages 6-10 years) preserves lung function to a greater extent than if KALYDECO is initiated at an older age (abstract WS17.03). These results show the importance of early initiation of KALYDECO for eligible patients.

These long-term and real-world studies show the potentially transformative benefits of treatment with CFTR modulators and add to the substantial body of evidence supporting treatment as early in life as possible, said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. We continue to make rapid progress in developing medicines that treat the underlying cause of CF, and today, we are closer to our goal of developing highly effective therapies for all patients with CF than ever before.

Additional Presentations

In addition to the studies noted above, other Vertex presentations at the conference this year support the long-term and early use of CFTR modulators:

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 83,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing the CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the early 30s.

About TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface by binding to different sites on the CFTR protein. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways.

TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one copy of the F508del mutation, or another mutation responsive to TRIKAFTA, in the CFTR gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 6 years of age.

Please see Important Safety Information below and [click here] for full U.S. Prescribing Information.

About KALYDECO (ivacaftor)

In people with certain types of mutations in the CFTR gene, the CFTR protein at the cell surface does not function properly. Known as a CFTR potentiator, ivacaftor is an oral medicine designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane, which helps hydrate and clear mucus from the airways. KALYDECO (ivacaftor) was the first medicine to treat the underlying cause of cystic fibrosis (CF) in people with specific mutations in the CFTR gene.

KALYDECO is a prescription medicine used for the treatment of CF in patients aged 4 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 4 months of age.

Please see Important Safety Information below and [click here] for full U.S. Prescribing Information.

About ORKAMBI (lumacaftor/ivacaftor)

In people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little to no CFTR protein at the cell surface.

ORKAMBI (lumacaftor/ivacaftor) is an oral medicine that is a combination of lumacaftor and ivacaftor. Lumacaftor is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del-CFTR protein. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of lumacaftor and ivacaftor help hydrate and clear mucus from the airways.

ORKAMBI is a prescription medicine used for the treatment of CF in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. ORKAMBI should only be used in these patients. It is not known if ORKAMBI is safe and effective in patients under 2 years of age.

Please see Important Safety Information below and [click here] for full U.S. Prescribing Information.

IMPORTANT SAFETY INFORMATION for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), KALYDECO (ivacaftor), and ORKAMBI (lumacaftor/ivacaftor)

Patients should not take KALYDECO or TRIKAFTA if they take certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; or St. Johns wort.

Patients should not take ORKAMBI if they take certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; the seizure medicines phenobarbital, carbamazepine, or phenytoin; the sedatives and anti-anxiety medicines triazolam or midazolam; the immunosuppressant medicines cyclosporine, everolimus, sirolimus, or tacrolimus; or St. Johns wort.

Before taking KALYDECO, ORKAMBI, or TRIKAFTA patients should tell their doctor about all of their medical conditions, including if they: have or have had liver problems; have kidney problems; are pregnant or plan to become pregnant because it is not known if KALYDECO, ORKAMBI, or TRIKAFTA, will harm an unborn baby; or are breastfeeding or planning to breastfeed because it is not known if KALYDECO, ORKAMBI, or TRIKAFTA passes into breast milk. Before taking ORKAMBI, patients should tell their doctor if they have had an organ transplant, or if they are using a hormonal contraceptive including oral, injectable, transdermal, or implantable form as this should not be used as a method of birth control when taking ORKAMBI.

KALYDECO, ORKAMBI, or TRIKAFTA may affect the way other medicines work, and other medicines may affect how KALYDECO, ORKAMBI, or TRIKAFTA work. Therefore, the dose of KALYDECO, ORKAMBI, or TRIKAFTA may need to be adjusted when taken with certain medications. Patients should especially tell their doctor if they take antifungal medications such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin.

KALYDECO or TRIKAFTA can cause dizziness in some people who take it. Patients should not drive a car, use machinery, or do anything that needs them to be alert until they know how KALYDECO or TRIKAFTA affects them.

When taking ORKAMBI, patients should tell their doctor if they stop taking ORKAMBI for more than 1 week as their doctor may need to change the dose of ORKAMBI or other medicines the patient is taking.

Patients should avoid food or drink containing grapefruit while taking KALYDECO or TRIKAFTA.

KALYDECO, ORKAMBI, and TRIKAFTA can cause serious side effects, such as:

Liver damage and worsening of liver function in people taking TRIKAFTA with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood have been reported in patients receiving KALYDECO, ORKAMBI, or TRIKAFTA. The patient's doctor will do blood tests to check their liver before starting treatment with KALYDECO, ORKAMBI, or TRIKAFTA; every 3 months during the first year of treatment; and every year while on treatment. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber colored urine.

Worsening of liver function in people with severe liver disease taking ORKAMBI. The worsening of liver function can be serious or cause death. Talk to your doctor if you have been told you have liver disease as your doctor may need to adjust the dose of ORKAMBI.

Breathing problems such as shortness of breath or chest tightness in patients when starting ORKAMBI, especially in patients who have poor lung function. If a patient has poor lung function, their doctor may monitor them more closely when starting ORKAMBI.

An increase in blood pressure in some people receiving ORKAMBI. The patients doctor should monitor their blood pressure during treatment with ORKAMBI.

Abnormality of the eye lens (cataract) in some children and adolescents treated with KALYDECO, ORKAMBI, or TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with KALYDECO, ORKAMBI, or TRIKAFTA to look for cataracts.

The most common side effects of KALYDECO include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.

The most common side effects of ORKAMBI include breathing problems, such as shortness of breath and chest tightness; nausea; diarrhea; fatigue; increase in a certain blood enzyme called creatinine phosphokinase; rash; gas; common cold, including sore throat, stuffy or runny nose; flu or flu-like symptoms; and irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding. Additional side effects seen in children include cough with sputum, stuffy nose, headache, stomach pain, and increase in sputum.

The most common side effects of TRIKAFTA include headache; diarrhea; upper respiratory tract infection (common cold), including stuffy and runny nose; stomach (abdominal) pain; inflamed sinuses; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; rash; flu (influenza); and increase in blood bilirubin.

These are not all the possible side effects of KALYDECO, ORKAMBI, or TRIKAFTA. Please click product link to see the full U.S. Prescribing Information for KALYDECO, ORKAMBI, or TRIKAFTA.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 12 consecutive years on Science magazine's Top Employers list and one of the 2021 Seramount (formerly Working Mother Media) 100 Best Companies. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements made by Dr. Bozic in this press release, statements regarding the potential benefits, safety and efficacy of our products, and our plans to present data about our portfolio of CF products at the ECFS European Cystic Fibrosis Conference, including an analysis of data from the ongoing five-year post-authorization safety study for TRIKAFTA, data comparing the annual rate of lung function change in certain individuals with CF and our assessment of the impact of such data, data regarding the early initiation of KALYDECO and our assessment of the impact of such data, and additional scientific presentations regarding our marketed CF products, including expectations regarding the abstracts that will be made available at the ECFS European Cystic Fibrosis Conference. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration, approval or further development of its compounds due to safety, efficacy or other reasons, risks related to approval and commercialization of our medicines, and other risks listed under the heading Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission (SEC) and available through the company's website at http://www.vrtx.com and on the SECs website at http://www.sec.gov. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

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Hormone-Replacement Therapy Is Life-Changing: What to Consider Before Getting Started – POPSUGAR

Posted: June 13, 2022 at 2:39 am

If you've experienced gender dysphoria the distressing feeling that occurs when your gender identity differs from the one you were assigned at birth you might have considered hormone-replacement therapy. Originally, HRT referred to the process of prescribing sex hormones like estrogen to people going through menopause as a way of treating symptoms such as hot flashes (a practice that has since been the subject of some controversy). But today, the term "HRT" is commonly used to describe "gender affirming hormone therapy" for "individuals who are seeking to alter their secondary sex characteristics for a more 'masculine' or more 'feminine' gender presentation," as defined by Folx, an online health and wellness provider for the LGBTQ+ community. At Folx and other gender-affirming-therapy providers, HRT involves using hormones like estrogen or testosterone to give the body a more traditionally feminine or masculine appearance to match one's gender identity.

While many trans and nonbinary people describe the medicine as life-saving, the process isn't for everyone, nor is it a requirement for trans and nonbinary people. "HRT does not make a trans person trans," stresses TikToker and professional actor Dylan Mulvaney, a trans woman who has been chronicling her self-described girlhood on the app. "If there is a trans person out there, and for whatever reason, they don't think HRT is right for them right now, or ever, we need to see them as such and respect their pronouns as such," Mulvaney adds.

The decision to start HRT is individual and can be complex. Sade Bolger, a Vermont-based activist and public-affairs organizer for Planned Parenthood, started HRT specifically testosterone therapy (or T) in May of 2017. But when he began, the decision was one of uncertainty. "When I did start T, I didn't really actually fully feel like I did know that for certain this is going to be the right thing," Bolger says. "I stepped into T in an explorative way, having seen other people who had gone through that process, and utilized it as a tool for self-discovery and self-exploration."

California-based Mulvaney echoes a similar sentiment: "The initial reason for going on HRT was just to sort of explore what that side to me was." Before beginning HRT, the actor had considered themself nonbinary for about 18 months. "But I always knew that I wanted to be more feminine," she says. "And even while I was nonbinary I knew that I loved the features on a woman, that I would love to have." Even so, she tells POPSUGAR, "I was so nervous to start [HRT] because it really is a huge decision to be potentially altering your body."

Josie Moon, another trans TikToker, also described her decision to start HRT as a tough one. Moon says she didn't know what the word "trans" meant until she was late into high school. The Nashville-based content creator got married at 24 years old, came out to her now-ex-wife as trans about two years into their marriage, and decided to get divorced just before the 2020 COVID lockdown. Through her own research, she discovered that some trans people don't take hormones. When making the choice for herself, she considered how it would affect her. "I was very concerned that even if I went on hormones at 29, it wasn't going to be enough for me to feel comfortable in my body," Moon tells POPSUGAR.

So she gathered more information, reading relevant threads on Reddit and Twitter and speaking to others in the trans community to make sure HRT was the right decision for her. "There's a subreddit called Trans timelines which shows pictures of mostly trans women but also trans men, really trans people in general before and after hormones," Moon says. "And I was like, wow, these people are the same age as me . . . and they look amazing. The results are amazing. So maybe this could work for me too." It had gotten to the point, Moon says, where she was constantly looking at these pictures and "imagining just feeling comfortable in my body and what that would look like." Now, two years on HRT, Moon is happy with her decision to start the therapy. So are Mulvaney and Bolger. "I look at myself in the mirror now and every day I get a little bit closer to finding myself to be a beautiful woman," Mulvaney says. "I think it was through the process of experiencing the changes that came alongside taking T that really kind of confirmed for me that this was what I wanted to do and who I wanted to be on the planet," says Bolger.

If you're still trying to figure out whether HRT is right for you, this explainer will help answer some of your questions, including what to ask your doctor, when to expect changes, and what side effects to be aware of.

Masculinizing or feminizing hormone therapy, also commonly referred to as hormone-replacement therapy or HRT, is a process used to "induce the physical changes in your body" caused by male or female hormones "to promote the matching of your gender identity and body (gender congruence)," per the Mayo Clinic.

Someone transitioning from male to female (MTF) would typically use feminizing hormone therapy and "be given medication to block the action of the hormone testosterone. You'll also be given the hormone estrogen to decrease testosterone production and induce feminine secondary sex characteristics," the Mayo Clinic states. In a female to male (FTM) transition with hormone therapy, "you'll be given the male hormone testosterone, which suppresses your menstrual cycles and decreases the production of estrogen from your ovaries."

The method in which those hormones are administered can vary, says Dave Usman, nurse practitioner at Radiant Health Centers, a California-based LGBTQIA+ Health and HIV care center. "It depends on the comfortability of the individual that's seeking hormone therapy," he says. For those receiving masculinizing HRT through testosterone, there are two options, Usman says. The most common route is injection. "It can be self-administered or office-administered," he says. There's also a topical gel option. For estrogen therapy, there's a pill, injectable, or patch.

Not every hospital or clinic provides gender-affirming healthcare. There are some instances in which medical providers can get exceptions, specifically hospitals and clinics with religious affiliations. It's important to do your research beforehand to ensure that you can get the care you need.

Bolger was referred to an endocrinologist after expressing to his therapist that he was considering HRT. Mulvaney recommends going to a queer health center in your area. "The great part is that they focus primarily on queer trans clients, so they are very in the know as far as treatment plans," she explains. Another good option? An informed-consent clinic, which means that a referral or therapy note is not required to receive care. (Planned Parenthood is an informed-consent clinic.) You can also receive hormone therapy online through services like Folx and Plume.

As far as cost goes, many insurance plans cover hormone therapy. For those who are uninsured or have trouble accessing hormone therapy, health centers like Radiant Health rely on contracted pharmacies that provide the medication at a low out-of-pocket cost for patients. Brands like Folx also offer an HRT care fund which distributes financial resources to an annual grant covering 12 months of hormone-replacement therapy, including prescription medication, unlimited clinical visits and messaging, and labs. Eighty percent of the Folx HRT grants are reserved for BIPOC. Eligibility starts at 18 years old, and you must live in a state where Folx is currently available.

"The first visit is mainly educating the patient, asking questions, and telling them what is expected," Usman says. "And then, once they have all the questions answered, they feel like they're ready, they're mentally and physically ready, that's when we start initiating therapy." That initiation point can be that day or weeks later. It's really about the patient's comfortability level.

Mulvaney first went to get information and ask questions about the process and then was prescribed spironolactone and estradiol. Spironolactone is a testosterone blocker and estradiol is a form of estrogen. "I went for the information, I got it, I got my mind put at ease. And then I started [the hormones] a few weeks later," Mulvaney says. She adds that she started out with a low dosage "because I was still new to it. I was nervous. I just didn't want to throw myself into it too fully quite yet."

One major conversation you should have with your provider, Mulvaney stresses, is about reproductive options, which will change during hormone therapy. Testosterone and estrogen therapy can lower your sperm count or egg production and may permanently change or stop your body's production of eggs and/or sperm altogether. So if someone is planning to undergo hormone therapy and they may want to conceive a child in the future, Usman says it's encouraged to do egg or sperm retrieval or freezing. "I actually didn't start the spironolactone until recently because I wanted to freeze my sperm first," Mulvaney says. "Being in my 20s, I just wanted to keep all my options open for the future and family planning because I don't know what that's going to look like when I'm older." But Bolger adds that not knowing what you want your reproductive options to be is OK, too. They started T when they were 19 years old. "I didn't know what I wanted to do reproduction wise I still don't. I'm 23 now, and I'm still figuring it out." But it's important that you know all of your options and make the decision that's best for you.

Everyone's timeline of changes is different, but Usman says you can start to see small physical changes as early as a month in.

"My first sort of notice was stretch marks on my booty," says Mulvaney. It was an unexpected surprise to her less than three months on HRT, in addition to a smoothing of her face and the loss of muscle mass in the chest. "I never had hard nipples before," Mulvaney says. "And now they are starting to bud."

For Bolger, the most notable initial changes were voice deepening, peach-fuzz hairs on the lip, and clitoral enlargement, which is commonly referred to as bottom growth. In terms of mood, Bolger says, "My libido pretty greatly increased and stayed kind of intense for the first couple of months into that first year." They also dealt with recurring mood swings. But this was predominantly "just during the period of time where my hormone balance was off because I was transitioning between estrogen and testosterone. And once I kind of plateaued with the T in my body, and that became the main hormone in my body, then all that stuff kind of settled out."

What's important to note is that the mental and emotional changes are just as important to address as the physical ones, and they may hit you sooner. "The first two weeks, I'm not gonna lie, were tough. I didn't feel like myself in some ways. My mind was foggy, I felt very emotional, I had some anxiety," says Mulvaney. These changes ultimately went away, or Mulvaney became accustomed to them. "I think my body learned to accept that this was the new normal and I started to feel like myself again," she says.

Therapy also helped, she adds. "I'm in therapy once a week and I have been with the same therapist for two years, it's changed my whole life and outlook on things." With HRT, you're seeing a doctor every three months or so for check-ins. "But you also need to have a support system in place that can help you with the day-to-day, because it can get pretty overwhelming," says Mulvaney.

Moon agrees that at times, the emotional aspects of HRT can become overwhelming. "When I was younger, I used to say I had three emotions angry, happy, neutral and that was just how it was," says Moon. But in starting HRT, she unlocked a new range of emotions with various depths and layers. "Angry is actually, 'I'm a little bit hungry, but I feel hurt and misunderstood and just sad in general.' And then when I was happy, I'm not just happy or euphoric, it's like, 'I'm excited about this and there's a little bit of joy about this.'" The whole process is "also a little bit bittersweet, because in transitioning, I get to be myself, but I also lost so, so much and had to rebuild," Moon says. "I think emotionally, it took me off guard."

One change that Bolger says he was the most unprepared for is the way others perceive him. "I absolutely took on male privilege," he says. "I noticed that I was being treated differently. The men in the room would shake my hand before they left. I was listened to more. There was more of a platform in a space, people kind of waited for me to have something to say." Emotionally, Bolger says it was "so weird." Because they don't identify as a man, "it was like switching from feeling misgendered on one side to feeling misgendered on the other side." He also says the transition between living the first 18 years experiencing sexism against women only then to be welcomed and respected by sexist men was "not ever in my intentions." There's this layer of complexity for nonbinary individuals, Bolger says, because T or no T, "we live in a society where people assume that you're either a man or a woman."

Another unexpected change? Anecdotally, many people on T have said that it changes their sexual attraction, especially as it pertains to men. Bolger says that being on T hasn't necessarily changed his attraction level to men but rather his comfortability level being with a man. "I felt really uncomfortable being with men, for example, when I was younger, because I knew that that would make people see me as a girl," Bolger says. Being on T changed the way people perceived them and how Bolger perceived himself. Ultimately, "T didn't make me stop loving women. T didn't make me start loving men. T didn't change anything about who I loved or who I f*cked. It changed my comfort, being in those relationships and having those experiences because of how I was feeling and perceiving myself."

Yes. "That's why we screen people initially for their past medical history and family history, because both [hormones] have side effects and adverse effects that can affect their overall health," says Usman. Hormone therapy can aggravate pre-existing depression and anxiety. Other complications include developing diabetes, high cholesterol, high blood pressure, and blood clots. If you're a chronic smoker in particular and you're on estrogen, "there's higher risk of developing blood clots," Usman says. So be sure to be honest about all of your lifestyle habits within that first meeting so that your provider can assess your needs and design a hormone-therapy plan that works best for you.

Bolger, for example, is neurodivergent. "I have ADHD. I sometimes struggle with routine, like hygiene care, because of that," Bolger says, and talking to his provider about that openly was "really important" in figuring out which form of T was right for them. For example, the topical gel has to be applied once a day. "It has to be a part of your routine and for me with my ADHD, that wasn't something that I really thought was going to be plausible," Bolger says. So he went with the weekly injections instead. Even so, Bolger experienced health complications, including ovarian cysts, which were caused by going off schedule on T, a diversion caused by his ADHD. That's why Bolger emphasizes the importance of seeking out a provider who can assess and treat your whole self someone who will be looking our for your mental, physical, and emotional health not just you as a trans person, but you as a whole human, too.

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Hormone-Replacement Therapy Is Life-Changing: What to Consider Before Getting Started - POPSUGAR

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High Doses of Widely-Used Cancer Drug in Hormonal Therapy Can Increase Risk of Brain Tumour in Women by Seven Times | The Weather Channel – Articles…

Posted: June 13, 2022 at 2:39 am

Representative image

Hormonal therapy has emerged as one of the most advanced treatments for cancer, premature puberty, and excessive hair growth. But, doctors here on Tuesday warned people to be conscious about the therapy and undergo tumour screening as the high doses of hormonal drugs can increase the risk of Meningiomathe most common benign brain tumourparticularly in women.

Meningioma is mostly a non-cancerous brain tumour arising in the layers of tissue (meninges) that surround and protect the brain and spinal cord. Although the majority of meningiomas are benign, these tumours can grow slowly until they are very large, if left undiscovered, and, in some locations, can be severely disabling and life-threatening.

World Brain Tumour Day is observed annually on June 8 to raise awareness of the condition.

The fluctuations in meningioma growth during the menstrual cycle, pregnancy, and breastfeeding are well-documented. These tumours have hormonal receptors in certain meningiomas located at the base of the skull.

"There is also an association between the growth of meningiomas and hormonal treatments, particularly prolonged and high dose use of the drug cyproterone acetate (CPA)," said Dr Nagesh Chandra, Senior Consultant and HOD, Neurosurgery and Spine Surgery, Aakash Healthcare. "The higher the dose, and the longer the drug is taken for, the greater the risk of meningioma," he added.

Cyproterone acetate is a steroid used in combination with Ethinyl oestradiol to treat women with severe acne. But recent studies, published in peer-reviewed journals Scientific Reports and The BMJ showed high doses of the widely-used drug can raise the risk of brain tumours by seven-fold.

In men, it is used to treat inoperable prostate cancer, while in women it is used for conditions such as severe acne and excessive hair growth. Very small doses are also used in birth control pills and hormone replacement therapy.

The occurrence of meningiomas has been reported in association with the use of cyproterone acetate, primarily at doses of 25 mg/day and above.

"When hormone medicine doses are high and therapy is prolonged, the chances of meningioma formation increase. Meningioma develops in the tissues that surround and protect the brain and spinal cord (meninges). However, the risk decreases significantly after the treatment is discontinued," said Dr Arun Sharma, Consultant, Neurosurgeon, Indian Spinal Injuries Centre.

"We've had a number of cases of meningioma in our hospital in the last couple of years. All of them had long-term usage of high-dose cyproterone acetate. This drug's dosage ranges from 25mg to 100mg daily, depending on the patient's condition. It has been discovered that cyproterone acetate increases the risk of meningioma by a factor of around 10," Sharma added.

However, it has been seen that the risk of meningioma decreases noticeably after hormonal therapy is stopped. Therefore, it's essential that people who use high dose cyproterone acetate for at least three to five years should be informed about the increased risk of meningioma by their doctor.

Symptoms of meningioma include changes in vision, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures or weakness in arms and legs.

If a patient is diagnosed with meningioma, treatment with cyproterone medicines must be stopped permanently, according to recommendations from the European Medicines Agency as well as the UK Health Security Agency.

The agencies recommend women take only daily doses of 10 mg. In men, cyproterone medicines should only be used to reduce sex drive in sexual deviations when other options for treatment are not suitable.

"Reasons for prescribing cyproterone acetate should also be clearly defined by the doctor. It should be prescribed with the lowest possible daily dose to avoid the development of tumours in the body. When prolonged use of high dose cyproterone acetate is necessary, more thorough screening should be considered, and in patients with a documented meningioma, cyproterone acetate should be discontinued," Sharma noted.

**

The above article has been published from a wire agency with minimal modifications to the headline and text.

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The heartbreak, hope and courage of a Maine transgender child – The Maine Monitor

Posted: June 13, 2022 at 2:39 am

Sometimes there are no words to take away her sons pain.

So Marie wraps her arms around her child and cries with him.

A few times a week, the 11-year-old breaks down, overwhelmed with the adversity he faces as a transgender boy. His peers, his mother said, have called him gross, stupid and a pervert.

The Penobscot County fifth-grader also suffers from gender dysphoria, a psychological condition that causes distress for those whose gender identity does not match their birth-assigned sex.

He despises the feminine body he sees when he looks in the mirror. He has pulled his hair out, cut himself and banged his head against the wall.

Its heartbreaking, his mother said. I validate him as much as I can, so that he knows at the end of the day that its not about him. He is not whats wrong.

You just try to keep telling yourself that you know who you are, explained the Penobscot County fifth grader. Photo by Fred J. Field.

A study recently released by the Williams Institute at UCLA estimated there were 5,900 adults 18 and older in Maine and 1,200 children aged 13-17 who identified as transgender.

The states transgender adolescents, according to the 2019 Maine Integrated Youth Health Survey, were twice as likely to have been bullied at school and four times as likely to have been threatened or injured with a weapon. Half of them had considered suicide compared to 15 percent of their non-transgender peers.

It can be really scary and isolating coming out, said Aiden Campbell, a transgender male who works at OUT Maine, an LBGTQ advocacy organization.

Living as a transgender youth in a largely rural state can be especially difficult. Medical and mental health resources are hard to come by, and growing up as a trans kid in a small town or school can be lonely and heartbreaking.

They may be the only one coming out in their school or town, said Campbell, who endured bullying before he transitioned and became the sole transgender student at Cony High in Augusta.

Campbell tried to end his life in 2012, believing he would never be loved or accepted.

I know what it feels like to be in a dark place and feel really lonely, he said. But kids shouldnt think suicide is the answer they have to turn to because they dont feel accepted.

Along with the struggle to fit in at school, at home or in their community, Maine transgender youths and their families are reeling from the heavy number of political attacks nationally.

More than 100 bills targeting transgender people have been proposed in other state legislatures since 2020, according to the American Civil Liberties Union. The bills include banning transgender students from playing girls or womens sports, using bathrooms that match their gender identity and criminalizing gender-affirming treatment for children.

Maines legislature has defeated proposed anti-trans laws in recent years, but the states Republican party amended its platform during its April convention to call for a ban on discussing transgender identity in schools. Former Republican Gov. Paul LePage, who is running for re-election, has supported laws restricting transgender rights.

Though Democratic Gov. Janet Mills has a history of voting for LBGTQ rights, advocates recently criticized her for removing a teacher-made video from the Maine Department of Educations website that discussed gender identity and same-sex relationships and was intended for kindergarten students. After the video was used in a Republican attack ad, Mills and the DOE eliminated it from the state website, saying the lesson plan was not age-appropriate for kindergartners.

The push to ban discussions about LBGTQ students in the classroom and to restrict their rights and medical treatment, frightens Marie, who is being identified by her middle name to protect her sons privacy.

I have a lot of feelings and fears about these laws, she said. To not get my son treatment is criminal. There is substantially higher risk of him committing suicide if he doesnt get help. And I will do anything I can to make sure that doesnt happen.

When parents like Marie seek resources for their children, they often turn to advocacy groups like Maine Transgender Networkor OUT Maine, which offer online support groups, workshops and links to medical and mental health professionals.

Medical care is typically provided at the states two pediatric gender clinics, in Portland and Bangor. The Gender Clinic at Barbara Bush Childrens Hospital at Maine Medical Center opened in 2015 because of a growing need to treat adolescents who had to travel out of state for services. The clinic has 1,000 patients ranging in age from 3 to 25 from Maine and New Hampshire, said the clinic program manager, Brandy Brown.

While most of the patients are between ages 14 and 19, there are some who are pre-kindergarten or in grade school.

With most of our young patients, the parents have a lot of questions, Brown said. Theyre here for support and guidance.

Younger pre-teen patients, Brown said, are generally exploring their gender with social transitions such as wearing clothes that may not align with their birth-assigned sex. Sometimes they also choose to rename themselves.

In the third grade, Maries son began altering his appearance to diminish his female characteristics.

He had these long waist-length curls and he shaved one side, Marie said. And then he slowly worked up (his head) until all of the sides were shaved and he just had a bit of hair on top.

At age 9, he told his mother, I think Im a boy.

The dark-haired, sensitive child did not waver in his chosen identity, Marie said. He changed his name and appearance in the spring of 2020 when his school went to remote learning during the pandemic. When he began attending a new school in the fourth grade in the fall, he dressed in baggy pants and shirts. His classmates, his mother said, accepted him as a boy.

Most of the kids in the class were new to him, said Marie. At that time the transition was pretty easy.

But a few students who knew him before began teasing him, Marie said. Others in the class also taunted him after her son explained, I was born a girl but now Im a boy.

It was a constant barrage, Marie said. Hes got a shaky self-esteem so if he is having a bad day, hes taking it out on himself.

His emotions, Marie said, pour out in a stream of self-hate.

Im ugly, he tells his mother. Im fat. Im stupid. Im not good enough. Nobody loves me. I wish I was dead.

He also continued to hurt himself, Marie said, cutting and scratching his arms until he left scars.

Sometimes there are no words to take away her sons pain. So Marie wraps her arms around her child and cries with him. Photo by Fred J. Field.

Marie sought help for her son at Northern Light Eastern Maine Medical Center Gender Clinic in Bangor, which opened in 2017 and currently has 200 patients. The clinics psychologist and endocrinologist a doctor who specializes in the bodys glands and the hormones they make evaluated Maries 11-year-old child and determined he had gender dysphoria.

While not all clinic patients receive medical treatment, doctors prescribed puberty blockers for Maries son, she said, to ease his distress. The medication suppresses hormones that would cause changes like breast development and menstruation.

He is very conscious of how his body looks and cries at the sight of it, Marie said. He wears these oversized T-shirts and loose baggy clothing to try and hide it. We were fortunate that he could start treatment before his puberty progressed.

Puberty blockers, explained Dr. Mahmuda Ahmed, the Bangor clinics lead pediatric endocrinologist, delay puberty and give children time to see if their gender identity is long lasting. The medication, Ahmed added, is also given to non-transgender youth experiencing early or precocious puberty.

The World Professional Association for Transgender Health supports the use of puberty blockers, and the countrys top medical associations, including the American Academy of Pediatrics, the American Medical Association and the American Psychiatric Association, also endorse some forms of treatment for transgender youth.

When it comes to puberty blockers, though, critics argue more research is needed to understand the medications effect on a patients fertility and bone density.

Once the blockers are stopped, an adolescents body begins to produce hormones again. Pausing the production of estrogen and testosterone hormones provides relief to children whose biological bodies do not align with their gender identity, said Dr. Anna Mayo, a psychologist who evaluates patients at the Bangor clinic.

All of a sudden your body is changing in ways that dont match your identity and that can be a really distressing time in a childs life, said Mayo.

When a transgender child does not receive treatment and undergoes puberty that conflicts with their identity, the results can be dire, said Susan Maasch, director of Trans Youth Equality Foundation, a Portland-based nonprofit that provides education and support for transgender youth and their families.

Kids begin to give up hope, Maasch said. They become destructive, do badly in school. Inevitably they fall into a deep dark place and need mental health services, or worse and they take their own life.

Gender-affirming care for adolescents is controversial in many states, and conservative groups like the Christian Civic League of Maine assert that such medical treatment harms youth. But Ahmed points to several studies, including a recent report published in the Journal of Adolescent Health,which found treatment of patients with forms of gender dysphoria lowered moderate or severe depression and decreased suicidal thoughts and attempts.

Often, doctors say, families have questions about medical research on transgender youth and are hesitant to seek treatment that will change their childs appearance. Sometimes children alternate between divorced parents who disagree on care or social transitioning a child with clothing and name changes.

The kids are stuck in the middle suffering, said Maasch. I have one child now where the mother accepts her (as a transgender girl) and the dad doesnt. Besides suffering depression, a kid who shows up to school one day dressed as a boy and then later dressed as a girl is more vulnerable and more likely to be harassed.

Using correct pronouns with transgender youth is important to affirm their gender. Photo by Fred J. Field.

Maine and most states do not have laws governing transgender pediatric care. Maines gender clinics follow the World Professional Association for Transgender Health guidelines. Depending on what provider they see, a youth can receive puberty blockers with only one parents consent. But surgery to alter a childs body or hormone replacement therapy which can feminize or masculinize an adolescents secondary sexual characteristics like facial hair and breast formation requires both parents permission.

In recent years, gender-affirming care for adolescents has become a controversial issue. As of March, according to the Williams Institute, 15 states have restricted access to treatment or are proposing laws to do so. Some of the bills criminalize medical care, and impose penalties on healthcare providers and families if they access puberty blockers, hormone therapy or surgery for a transgender child.

Concerned about the political battle over medical treatment for transgender minors, the AMA has urged governors to veto legislation that would prohibit care, saying it is a dangerous intrusion into the practice of medicine.

Forgoing gender-affirming care, the AMA wrote in a 2021 letter to the National Governors Association, can have tragic health consequences, both mental and physical.

Laws to criminalize care for transgender minors disturbs Marie, but it is not a topic she discusses with her son, knowing it will upset him.

We dont talk about whats going on in Texas (and other states) right now because I have a lot of feelings about it and a lot of fear, Marie said.

Though Marie has primary custody of her son, her ex-husband, she said, does not support gender-affirming care and continues to call their child by his feminine birth name. The slight, referred to as dead-naming among transgender people, is painful, explained Marie son, who has chosen the new middle name Lion to represent his courage.

You just try to keep telling yourself that you know who you are, said Lion. I try to talk to my dad about it, but it just escalates and gets into a fight.

When his father calls him by his birth name or refers to Lion as she or her, the fifth-grader tries to not let the pain affect him.

I try to stick up for myself, he said. I try to be like Batman or the Green Lantern, tough like them.

Last Christmas, Lions father wrote both his feminine birth name and his new masculine chosen name on gift tags for his presents. The gesture gave Lion hope.

Maybe things will get better, he said.

A child caught in the middle of a familys polarizing views frequently experiences trauma, said Carmen Leighton, a mental health counselor who specializes in treating LBGTQ youth.

Often we see a divide in the family, which can be very destructive, said Leighton, a therapist at Higher Ground Services in Brewer. And every time it falls on a trans kid who feels like, I know that this is my truth, my identity, but its causing all of this conflict, so its my fault.

Parents often wrestle with fear and grief, Leighton said, when they try to understand why their childs birth sex does not align with their chosen identity.

Its the fear of the unknown and its the grief of I birthed this person and gave them this name, Leighton said. And then this grief that Im losing my daughter or Im losing my son and theyre becoming someone that I may not recognize anymore.

Parents often wrestle with fear and grief when they try to understand why their childs birth sex does not align with their chosen identity, said Carmen Leighton, a mental health counselor who specializes in treating LGBTQ youth. Photo by Fred J. Field.

As transgender children become teenagers, they tend to arrive at the Portland clinic with more complex problems and needs, said Erin Belfort, a child and adolescent psychiatrist. Roughly 65 percent of the youth referred to Belfort have a mental health diagnosis such as depression, anxiety or thoughts of suicide. Some have been hospitalized after suicide attempts.

Trying to navigate adolescence is hard enough, Belfort said. But trying to do so in a world that doesnt see you as you see yourself, especially if you dont have support at home, is incredibly stressful and traumatizing for kids.

Belfort sees youths from every Maine county, including the states rural pockets, where kids may struggle to find acceptance.

Though Maines non-discrimination laws protect all students to ensure they learn in a safe environment, transgender youths experiences vary depending on which schools they attend, Belfort said.

Kids who go to arts academies feel like they have great community and people really celebrate their identities, Belfort said. Then I have kids too who dont feel safe going to school with other students who are wearing (Make America Great Again) hats and driving their pickup trucks with a shotgun in the back.

While schools try to prevent bullying and harassment, it still happens, Belfort said.

The lack of mental health services throughout Maine and especially in rural areas makes it difficult for families to get their children help if they are feeling isolated or rejected.

After an initial evaluation, Belfort and doctors at the Bangor clinic refer patients to mental health providers in the community. But wait lists are long, especially in counties like Washington, Franklin and Piscataquis.

One of our primary challenges is finding mental health clinics, said Dr. Mayo, of the Bangor clinic. We have patients waiting more than six months to find providers.

Marie feels fortunate she was able to get her son treatment for his gender dysphoria. She is also grateful that Lions counselor is trained in the specific needs and trauma of transgender youth.

Its so hard to find trans competent care and people that really understand these kids, Marie said.

Lion, like many others, hopes for a day when transgender individuals would be viewed as an equal. I want acceptance for me and for everybody, he said. Photo by Fred J. Field.

Lion will likely continue taking puberty blockers until he turns 15, Marie said. Then it is unclear whether he will be able to receive hormone therapy to further transition his body.

If his father does not consent, Lion must wait until turning 18.

For now, hes grateful that the medication is giving him the chance to be a regular boy who loves baseball and likes to draw.

Asked to describe himself, he quickly answers, Im smart, brave and competitive, yeah, and kind.

The 11-year-old wishes people would just stop being mean to him and others who are different.

I want acceptance for me and for everybody, he said. Like racism, too. I wish it would all stop.

This series was financially supported by The Bingham Program and the Margaret E. Burnham Charitable Trust. We encourage you to share your thoughts on this series by visiting this page. Barbara A. Walsh can be reached at barbara@themainemonitor.org.

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The heartbreak, hope and courage of a Maine transgender child - The Maine Monitor

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Pride Week: Beginning Hormone Replacement Therapy : Short Wave – NPR

Posted: June 13, 2022 at 2:39 am

Medical transition-related treatments like HRT are associated with positive physical and mental health outcomes. amtitus/Getty Images hide caption

Medical transition-related treatments like HRT are associated with positive physical and mental health outcomes.

Medical transition-related treatments like hormone replacement therapy are associated with overwhelmingly positive outcomes in terms of both physical and mental health for transgender people. But, it can be hard to know exactly how to get started. Reporter James Factora explains where to start, common misconceptions about HRT, and the importance of finding community through the process. Read James' full reporting here:

If you're just learning about hormone replacement therapy for the first time, welcome! We're so glad you're here. You might want to read about the basics before listening to this episode. We'll be here when you get back!

This episode was produced by Brit Hanson, fact-checked by Indi Khera and edited by Viet Le. Joshua Newell and Kwesi Lee provided engineering support.

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Latest study reveals that two male contraceptive pills could expand options for birth control – Interesting Engineering

Posted: June 13, 2022 at 2:39 am

The first product for male birth control isalmosthere.

In the first phase of clinical trials, two experimental male contraceptive pills -DMAU and 11-MNTDC - appearedto effectively lower testosterone without causing unacceptable side effects.

The study will be presented on Monday at ENDO 2022, the Endocrine Society's annual meeting in Atlanta, Ga, as per a press release.

According to the researchers, there are similar pathways for the hormonal control of reproductive function in women.

"We are building on the knowledge of many decades of contraceptive development for women as well as our success with other combination hormonal methods such as Nestorone (a progestogen) and Testosterone gel for regulating LH secretion and sperm production in men," lead researcher,Tamar Jacobsohnof the Contraceptive Development Program (CPD) at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Dr.Diana Blithe, Program Chief of CDP, toldIEin an interview.

Ever since thebirth control pill was first approved as a contraceptive in the US in 1960, the onus of birth control has largely fallen on people with female reproductive systems.

According to the Centers for Disease Control and Prevention(CDC), in 2015-2017, 64.9 percent of the 72.2 million women aged 1549 in the United States were using contraception, with the most common method being female sterilization, oral contraceptive pills, long-acting reversible contraceptives (LARCs), and the male condom (8.7%).

Data from the 20152017 National Survey of Family Growthrevealed that nearly all women use some form of contraception methodat some point in their lifetime. Currently, the US Food and Drug Administration has approved 17 birth control methods for people with female reproductive systems and only two for people with male reproductive systems - condoms and vasectomy. Some people also practice methods such as natural family planning (or "fertility awareness") or the pullout method, but both of these methods have a very high rate of failure.

In recent years, there have beenreports of trials for hormone gels and injectionsfor men, but these are not widely available. According to data from Global Market Insights, if a new male contraceptive method were to be approved in the next five years, the market is projected to be around $1 billion by 2024 and could grow at the rate of six percent over the next ten years,

As yet, however, there areno new birth control methods on the market for those who produce sperm.

There have been several challenges when it comes to developing a male hormonal contraceptive.

"The first includes developing a first-of-its-kind drug to be used by healthy men who do not face health risks from pregnancy," said Blithe and Jacobsohn.

This sets the bar for safety very high. As always, with the new medication, extensive testing is required to ensure that there are no health risks, which is different from the side effects, they stressed.

Androgens are male hormones; these are naturally produced in the body and are a requirement for the normal sexual development of both males and females. In males, the predominant androgen is testosterone. In genetic males,testosterone has a number of roles, includingregulating sex drive, bone mass, fat distribution, muscle mass and strength, and the production of red blood cells and sperm.

However, current formulations of oral testosterone derivatives require multiple doses per day.

There have been a number of obstacles to the development of a male oral contraceptive.One is that reliably and completely blocking the production of millions of sperm every day (in males) versus preventing the release of a single egg a month (in females) is a lot more complicated, biologically speaking. Those drugs that have been tested have often had serious side effects.

However, there has also been little interest from largepharmaceutical companies, some of whom make billions from the female contraceptive pill, and there is little funding available for clinical trials of these drugs. All of this makes the research more challenging.

However, "With more awareness of the potential market for these products, through clinical trials and acceptability trials globally, large pharmaceutical companies may become more interested in supporting the research. If that happens, through our research efforts and the efforts of male contraceptive development generally, it could help speed up the process of developing more options for men," Blithe and Jacobsohn said.

The drugs involved in the current study are Dimethandrolone (DMA) and 11-methyl-19-nortestosterone (11-MNT), which areprogestogenic-androgens,which means they are single agents with two functions.

To elaborate, "the progestogenic function serves to lower the pituitary production of gonadotropin hormones (FSH and LH). Inhibiting LH leads to lower testosterone in the testis," according to Blithe and Jacobsohn.

In theory, sperm production would be inhibited in the absence of adequate testosterone in the testis.

Why these specific compounds?

"The androgenic function of these molecules supports sexual function and other bodily functions that rely on adequate testosterone levels in the blood. These progestogenic androgens are being tested because they are orally bioavailable and thus can be used as a pill (research shows that men would like to use oral pills), and because both functions may be delivered with a single drug instead of two combined drugs," Blithe and Jacobsohn explained.

The study included 96 healthy male participants in two Phase 1 clinical trials. As aforementioned, the usage of DMAU and 11-MNTDC suppress testosterone. Lowering testosterone levels can lead to unpleasant side effects, but most men involved in the study were willing to continue using the drugs.

"Many of the men joining our clinical trials are extremely enthusiastic about the prospect of male contraception. They are dedicated to helping move the product forward through clinical trials," Blithe and Jacobsohn said.

In each trial, the men were randomly assigned to receive doses of two or four oral pills, of either the active drug or the placebo, daily for 28 days. Testosterone levels in those taking the active drug notably dropped below the normal range after seven days on the active drug. And in men taking the placebo, testosterone levels stayed within the normal range.

Among the participants, 75 percent of the men who took the active drug said that they would be willing to use it in the future, in comparison with 46.4 percent of those who took the placebo.

It was also observed that men who took the four-pill daily dose (400 milligrams) had lower levels of testosterone than those taking the two-pill, 200-milligram dose.

Despite thefact that lowering testosterone levels can lead to unpleasant and serious side effects, many researchers favor contraceptives that use hormones.

"Research on non-hormonal methods is quite active, with several different mechanisms being explored," Blithe and Jacobsohn said.

A few months ago, a team of researchers based at the University of Minnesota Twin Cities tested the compound YCT529,which focuses on receptors for a specific form of vitamin A, called retinoic acid, that's essential to the growth and development of cells and embryos. After the drug was given to mice for several weeks, the pregnancies among the mice went down.

"No [non-hormonal medication] has successfully transitioned to clinical evaluation, but progress is being made toward that goal. It cannot be assumed that non-hormonal methods will be free of side effects, so we will have to wait for those clinical trials to begin to see if anything emerges that was not evident in pre-clinical qualifying studies," Blithe and Jacobsohn said.

Jacobsohn and her team are working with contraceptive mechanisms to replace androgen function either with testosterone or other androgenic drugs to minimize or prevent side effects.

And in the current studies, no adverse effects or side effects were observed with either of the drugs. "Mild side effects included acne and changes in libido (both increased and decreased), headaches, and erectile dysfunction in a few individuals. All side effects were resolved by the end of the study," they said.

In the Phase 1b trial of testing, the researchers are looking at the pharmacodynamics, pharmacokinetics, and safety of the drug.

After Phase 1 trials, longer and larger studies are required, the researchers pointed out. "Since the treatment is used in healthy men, the studies are sequential and escalating to ensure that safety is maintained across longer treatment in a larger number of individuals," Blithe and Jacobsohn said.

Phase 2 trials would look at the longer periods of treatment to confirm safety "and determine if the drugs can inhibit sperm production."

Additionally, researchers at the CDP are also amid conducting a Phase 2b (efficacy) trial for a combination Nestorone/Testosterone gel product, "which we hope will be the first groundbreaking product for male contraception, thus paving the way for other drugs to become available within the next ten years," Blithe and Jacobsohn said.

If drugs successfully reach Phase 2b efficacy testing in couples, the trials will be lengthy, requiring a two-year commitment from couples to demonstrate suppression, efficacy, and recovery. Discussions with the FDA on what would be expected in Phase 3 will take place if the Phase 2 trials are successful.

The researchers are hoping to create a birth control pill that can be taken once daily, like those which are available for women.

"Given that these drugs also combat the side effects of hypogonadism with their androgenic effects, further research is necessary to look at them as a possibility for androgen replacement therapy as well. Similar to the use of hormonal birth control for women for a variety of reasons other than pregnancy prevention, the same may be possible for men," Blithe and Jacobsohn said.

Just the prospect of male contraception becoming widely available is imperative for reproductive autonomy and equality. "The development of contraceptive products for men will both increase available options for men and allow for many women to have more options for sharing the contraceptive burden," they added.

Abstract:A promising development in hormonal male contraception (HMC) is a class of bifunctional prodrugs that combine both androgenic and progestogenic activities into a single molecule. Examples of these prodrugs currently being studied are dimethandrolone undecanoate (DMAU) and 11-methyl-19-nortestosterone-17-dodecylcarbonate (11-MNTDC) (1, 2). The inactive prodrugs are cleaved to release active drug over a 24-hour timeframe, providing once-a-day dosing. As potent androgens, these steroids suppress gonadotropin secretion, leading to markedly decreased serum testosterone production and circulating levels. Low testosterone levels might lead to unpleasant symptoms of hypogonadism if DMAU and 11-MNTDC are not providing sufficient and effective androgenicity. Therefore, we examined the impact of the novel progestogenic androgens on serum testosterone levels and acceptability of varying dosages of these oral prodrugs in a secondary analysis of two Phase 1 placebo-controlled trials. Healthy male participants were randomized to take two or four oral pills of active drug or placebo per day. As DMAU and 11-MNTDC share similar mechanisms of action and tolerability, we examined the association of dosage as well as testosterone concentrations on combined drug acceptability versus placebo. Survey respondents across the two trials (39 DMAU, 30 11-MNTDC, 28 combined placebo group) shared similar baseline demographics. After seven days of usage, testosterone levels for those using either prodrug dropped to levels below 100 ng/dL while testosterone levels for those using the placebo (400-600 ng/dL) remained within the reference. Recipients of either DMAU or 11-MNTDC reported greater willingness to use the active prodrug in the future (75%), compared to placebo recipients (46.4%, p=0.007). Throughout the 28-day oral pill usage, while average testosterone levels during the period of suppression (day 7 to 28) were very low, they were significantly higher in the 200 mg group than in the 400 mg group (92.7 ng/dL vs. 49.6 ng/dL, p-value <0.001). Participants using 2 pills (200 mg, n=33) versus 4 pills (400 mg, n=35) of active drug did not report a significant difference in general satisfaction, willingness to use in the future, or recommendation of the study pill to other men (p=0.85, p=0.48, p=0.60, respectively). In placebo-controlled trials, men randomized to use active, daily oral progestogenic androgen prodrugs reported greater acceptability with their respective regimens than did men who received placebo pills despite low serum testosterone levels. Oral hormonal male contraceptive pill prototypes, DMAU and 11-MNTDC, significantly suppress serum testosterone while providing sufficient androgenicity to be acceptable to most men.

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Trans conversion therapy: What to expect when MPs debate ban – Open Democracy

Posted: June 13, 2022 at 2:38 am

By contrast, genuine therapeutic interventions involve the safe exploration of an individuals needs and uncertainties, and value self-awareness and self-acceptance, campaigners explained. This doesnt mean that you dont challenge or question [the client], or help them explore who they are. But the starting point is one of respect and dignity for the individual, said Jayne Ozanne, a gay evangelical Christian and director of the Ozanne Foundation, which works with religious organisations to eliminate discrimination based on gender and sexuality.

[Therapeutic] conversations are intended to be exploratory, said Cara English from Gendered Intelligence. Theyre about meeting people where they are and not giving them a fixed destination.

Theres this wilful misinterpretation that people will be telling young people that theyre trans and working backwards from there. Its just so bizarre to see it be voiced like that. But it will inevitably be voiced like that by parliamentarians on Monday.

Affirmative care is about getting rid of the psychotherapists agenda and focusing on the patient, Moore agreed. Reflective work is absolutely possible in an ethical, affirmative way.

This distinction is upheld in the Memorandum of Understanding on conversion practices a joint statement signed by 25 health, counselling and psychotherapy bodies including the British Association for Counselling and Psychotherapy, the Royal College of Psychiatrists and NHS England which defines conversion practices as therapy or persuasive techniques designed to prejudice peoples choices about gender change or sexual orientation.

Moore also highlighted a tendency for opponents to deliberately conflate medical affirmation treatments like hormone replacement therapy and affirming surgeries with the affirmative therapy model.

Its a different thing altogether, she said. When were talking about therapy, were referring to talk therapy Unless they also happen to be endocrinologists or surgeons, psychotherapists are not prescribing hormones or other medical interventions.

Opponents of a trans-inclusive ban may also claim that trans conversion practices arent happening, or that there is insufficient evidence to show that these practices cause harm, say campaigners.

The governments own 2018 survey found that trans people are more likely to undergo conversion practices than lesbian, gay and bisexual people. Some 13% of trans respondents said they had been offered some form of conversion therapy.

And while there is no evidence that these practices can succeed in changing sexual orientation or gender identity, there is significant research and first-hand testimonies underscoring their severe, long-term and sometimes deadly psychological consequences.

Research carried out last year by a coalition of UK LGBT charities, together with independent research monitor Richard Matousek, found that gender-diverse participants who had experienced conversion practices were nearly twice as likely to have attempted suicide.

These findings are consistent with a 2018 study published in the American Journal of Public Health, which found that LGBT young people who had experienced conversion practices were more than twice as likely to report attempting suicide following the experience. The American Psychological Association has also linked conversion practices to depression and suicidality in survivors.

To deny that these practices are happening invalidates the experiences of countless survivors who have come forward and testified to the harm caused, Appan said. Its a kick in the face, and it denies my current life. The trauma I faced has led to lifelong health conditions, including fibromyalgia and complex post traumatic stress.

Its cruelty, said Ozanne, who is herself a survivor of conversion practices. What angers me most is the indifference of those who practice conversion therapy and have no remorse for the harm they have caused.

All recent legislative bans, including those implemented in Canada, France, New Zealand and Greece, include both sexual orientation and gender identity. Excluding trans people from the ban on conversion practices would be outdated, harmful and an international embarrassment, said Lui Asquith, from Mermaids.

I hope more than anything that the reality of the lived experiences of trans people will come through in the debate on Monday Its incredibly important that we debunk the false myths that are being spread and that we understand the harm that trans people are facing, Ozanne said.

It will be a dereliction of our duty as a society that is meant to protect the vulnerable if we do not include them in the ban.

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COVID-19 protocols for upcoming commencement events and reminder of mandatory indoor masking – COVID-19 and vaccine resources – ucla covid-19

Posted: June 13, 2022 at 2:37 am

June 6, 2022

COVID-19 Response and Recovery Task Force

What you need to know:

Dear Bruin Community:

We wanted to take a moment to thank our campus community for your efforts to make our academic year a safer one. We know this has been another challenging year, and your patience and perseverance is greatly appreciated.

Cases of COVID-19 have remained high in Los Angeles County over the past four weeks with new variants in circulation. The reinstatement of universal indoor masking for students, faculty, staff and campus visitors will help stabilize our campus case rates. As we approach end-of-year celebrations and graduation ceremonies, we want to remind you to make these special occasions safer for all guests and attendees.

Well-fitting upgraded masks or respirators are required for all students, faculty, staff and campus visitors while indoors on UCLA property, except when alone in a room, eating or drinking, or in your living units with your household. Masking is also highly recommended in crowded outdoor settings. Wearing a properly fitted mask reduces the risks of getting the virus or spreading it to others.

Upgraded masks are available to students, faculty and staff free of charge at the UCLA Emergency PPE Supply Store, the John Wooden Center, all residence hall front desks, the Student Activities Center and in Ackerman Union at the A-level information window (next to the post office).

As a reminder, those attending indoor commencement ceremonies and celebrations, including UCLA affiliates and external guests, must mask indoors at UCLA. Commencement speakers may remove their masks to deliver their graduation addresses and graduates may momentarily remove their masks while walking across the stage and while being photographed on or adjacent to the stage.

Event organizers are strongly encouraged to request surgical masks from the PPE store and have them available at these gatherings. Free masks will be available this Friday through Sunday for graduates and guests at most commencement venues. Rapid antigen tests will also be available at Bruin Plaza and the Dickson Plaza Flagpole. Please refer to the Commencement COVID-19 FAQs below for more information.

We are anticipating street closures, increased traffic delays and high parking demand on Friday. Plan to allow additional time to get to campus prior to your commencement event and prepare for hot weather. We recommend guests arrive at Pauley Pavilion for College Commencement ceremonies at least one hour prior to the time printed on your tickets.Please visit the College Commencement FAQ site for more information regarding commencement.

Masking at other events off campus will also help curb the spread of the virus. There is still a lot we do not know about the health impacts of COVID-19. You should continue to avoid getting infected or reinfected to the extent possible.

Together, we can make our end-of-year events memorable and help reduce the risks. We have experienced a remarkable academic year, and that has largely been due toour communitys commitment to caring for one another. We thank you for all of your continued efforts and wish you a happy and healthy summer.

Sincerely,

Michael J. BeckAdministrative Vice ChancellorCo-chair, COVID-19 Response and Recovery Task Force

Megan McEvoyProfessor, Institute for Society and Genetics, Department of Microbiology, Immunology and Molecular GeneticsCo-chair, COVID-19 Response and Recovery Task Force

NOTE: Those who work in UCLA Health clinical areas (including medical, dental and nursing clinics) must follow the COVID-19 protocols for health care settings. However, those who work in both clinical and non-clinical settings must also comply with these campus protocols when outside of the health care environment.

UCLA pre-K12 facilities (including early care and education centers, UCLA Lab School and Geffen Academy) will continue to follow specific protocols that were previously communicated separately from the schools.

Do I need to wear a mask at UCLA commencement?

In response to a consistent rise in COVID-19 cases in Los Angeles County and on the UCLA campus, beginning Friday, May 27, the University reinstated a universal indoor masking policy for all students, staff, faculty, affiliates and visitors to the UCLA campus regardless of vaccination status. This requirement applies to, and will be enforced at, all indoor 2022 commencement ceremonies. It will also apply to guests and graduates temporarily going indoors to utilize University facilities or shop at campus retail establishments.

The below masking exceptions at indoor UCLA commencement ceremonies are permitted:

In addition to the above ceremony exceptions, those dining indoors at campus restaurants may remove their masks while eating or drinking. However, outdoor dining and to-go options are strongly encouraged.

A complete list of all current campus protocols addressing COVID-19 prevention, vaccines, testing, exposure management and isolation/quarantine can be viewed on the UCLA COVID-19 website.

I am a commencement guest. Do I need to be vaccinated or tested to attend commencement at UCLA? Will tests be available on site?

Currently, guests do not need to present proof of vaccination or a negative COVID-19 test to come to campus or enter a commencement venue.

As a precautionary accommodation for visiting guests who are concerned about potential exposure during travel, UCLA will have rapid antigen tests available at Bruin Plaza and the Dickson Plaza Flagpole. These tests will be provided free of charge and be distributed on a first come, first served basis. Anyone testing positive must not attend these events and must follow isolation rules.

I am a graduate. Do I need to be vaccinated or tested to attend commencement at UCLA?

All graduates must be in compliance with the UC Systemwide COVID-19 Vaccination Policy and must test in accordance with the ongoing UCLA surveillance testing program and receive a negative result prior to their ceremony.

More information on the established Spring Quarter COVID-19 requirements for faculty, staff and students can be found on the UCLA COVID-19 resources website.

What if I have COVID-19 symptoms?

Anyone who is symptomatic must not attend commencement events.

UCLA students, faculty, and staff must complete the campus daily symptom monitoring survey prior to arriving on campus.

What if I am traveling to UCLA from out of state?

Those who plan to attend should stay informed about the California Department of Public Healths and LA County Department of Public Healths most recent guidelines.

What happens if Los Angeles County moves back into more restrictive COVID-19 tiers between now and commencement weekend?

The situation with the pandemic is fluid. If Los Angeles County moves back into more restrictive tiers, the State and County guidelines could introduce new requirements for the events to be held. Information on protocol updates will be communicated to guests by email or other appropriate mechanism.

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