individuals at risk only from receptive vaginal . The study could be good news for Sprout which was approved by the FDA in 2015 but has yet to prove to be the financial boon expected that led to the $1 billion sale of the company in 2015. 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Wade. Descovy (emtricitabine and tenofovir alafenamide) Consumer information. In adults and children who weigh at least 77 lb (35 kg), in combination with other HIV medicines. Sometimes it is not safe to use certain . Descovy for PrEP offers healthcare providers and appropriate people at risk for HIV an additional biomedical prevention option with a demonstrated improvement in bone and renal safety parameters as compared to Truvada.. If you have any other medical conditions. This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the US Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections, said Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDAs Center for Drug Evaluation and Research. According to the Centers for Disease Control and Prevention (CDC), PrEP is highly effective at reducing the risk of HIV infection in at-risk populations. Descovy for PrEP provides a new HIV prevention option that matches Truvadas high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time, Daniel ODay, Gileads CEO, said in a statement. WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.. Its not known how effective PrEP is for insertive anal sex, insertive vaginal sex, or how long it takes for the PrEP injection to work. DESCOVY (emtricitabine and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2015 WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS Descovy has a Boxed Warning in its U.S. product label regarding the risk of post treatment acute exacerbation of hepatitis B. Women gained more weight overall than men, and the weight gain seemed to be progressive (it did not plateau, even after 96 weeks). than F/TAF. You may report side effects to FDA at 1-800-FDA-1088. The FDA approved Descovy in 2015 as a PrEP medication to reduce the risk of getting HIV and as an ARV for people with HIV infection. As the immune system gets stronger, it may have an increased response to a previously hidden infection. BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. The trial compared once daily Descovy to Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg), a daily fixed dose combination of two drugs approved in 2012 to prevent the sexual acquisition of HIV; participants were followed for 48 to 96 weeks. A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . Flu-like symptoms may be a sign that you could have recently gotten HIV. Prevention methods, including PrEP, and safer sex practices are essential tools in the effort to end the HIV epidemic. Seven years after Truvada (F/TDF) was approved for HIV prevention as PrEP, we now have another PrEP medication option. Among people who inject drugs, PrEP pills reduce the risk of getting HIV by at least 74%. Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men. You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Keep the bottle tightly closed when not in use. While the magnitude of these changes is not alarming, overall these relatively small changes in LDL among those taking F/TAF need to be evaluated for possible clinical significance in the context of an individuals age, lifestyle issues, and other cardiac risk factors. The primary efficacy endpoint of DISCOVER was the incidence of documented HIV infection per 100 person-years after all participants had follow-up of at least 48 weeks and at least half had 96 weeks of follow-up. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the, If HIV-1 infection is suspected or if symptoms of acute infection are present while taking DESCOVY FOR PrEP, convert the DESCOVY FOR PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the. In the DISCOVER study, which demonstrated that F/TAF was non-inferior to F/TDF for PrEP (but did not determine that it was superior to F/TDF), there were fewer HIV infections among people taking F/TDF (11 infections) than among people taking F/TAF (6 infections; these numbers exclude people who had suspected acute HIV infections at baseline). Taken together, they earned nearly $3 billion in the fourth quarter of last year. , people taking F/TAF had an average 6% rise in LDL, while people taking F/TDF had only a 2% rise. Descovy (emtricitabine/tenofovir alafenamide) - Expanded indication, new strength On January 7, 2022, the FDA approved Gilead's Descovy (emtricitabine/tenofovir alafenamide), in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg. Descovy side effects (more detail) What other drugs will affect Descovy? Descovy comes in tablet form in the following strengths: Take Descovy according to your health care providers instructions. While taking Descovy, it is important to keep all of your appointments with your health care provider. The trial included 5,313 men and 74 transgender women who have sex with men, Mandavilli reports. Generic name: emtricitabine and tenofovir [EM-trye-SYE-ta-been-and-ten-OF-oh-vir-] ET, U.S. Food and Drug Administration Approves Descovy, Biotech layoffs gather pace as industry downturn persists. Efficacy was strongly correlated to adherence to daily dosing. The AIDS Healthcare Foundation claims the companydeliberately delayed bringing TAF to market in order to maximize the patent life of its HIV franchise. he/him. PrEP use received an A rating from the U.S. Preventive Services Task Force (USPSTF), signifying that PrEP has a high certainty of substantial preventive benefits for reducing the risk of HIV. In the United States, the WAC for a 30-day supply of DESCOVY 200/25 mg is $1,466 .44 or about $17,842 per year . These include a buildup of lactic acid in the blood (lactic acidosis),liver problems, and new or worsening kidney problems, including kidney failure. These and other risks are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, as filed with the U.S. Securities and Exchange Commission. In addition, the Advancing Access program offers a range of options to assist patients with obtaining information about insurance coverage and investigating insurance benefits for their Gilead medication. Provided in collaboration with NIHs Office of AIDS Research. In this trial, weight gain with emtricitabine and tenofovir alafenamide was assessed in 6908 people living with HIV (PLWH) who switched from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF). Gilead earned the FDA's approval for Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg) for HIV-1 pre-exposure prophylaxis (PrEP). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. People in the F/TAF + DTG group gained on average 6 kg (13.2 lbs) after 48 weeks and 8 kg (17.6 lbs) after 96 weeks. There is some evidence that F/TAF causes progressive weight gain in people taking it for PrEP or in combination with other drugs for HIV treatment. Gilead has long been buffeted by HIV activists like the PrEP4All coalition over the high price of Truvada and the circumstances of Truvadas development and testing, which was largely funded by private donors and the U.S. government. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Heres how theyre performing. AI-powered legal analytics, workflow tools and premium legal & business news. immune reconstitution inflammatory syndrome, Yellowing of your skin or the whites of your eyes (, Loss of appetite for several days or longer, Pain, aching, or tenderness on the right side of your stomach/abdominal area, Bone pain that does not go away or gets worse. Emphasizing patient education and patient-centered choice in selection of suitable and comfortable PrEP options is an important start. In the ADVANCE study, which included more than 1,000 men and women living with HIV, people taking F/TAF + dolutegravir (DTG) gained significantly more weight over the course of 96 weeks than people taking F/TDF + DTG. Available for Android and iOS devices. The reader is cautioned not to rely on these forward-looking statements. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. "Vitamn C njdete v ovoc, ako s pomarane a jahody, a vitamn E v . See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information. Descovy may cause serious side effects. Descovy for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status and should only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every three months during use. The safety and efficacy of Descovy for PrEP were evaluated in a randomized, double-blind multinational trial in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving Descovy for PrEP. Please login or register first to view this content. It was first FDA approved in April 2016 and indicated, in combination with other antiretroviral agents, Descovy can cause serious, life-threatening side effects. Seven years after Truvada (F/TDF) was approved for HIV prevention as PrEP, we now have another PrEP medication option. Tell your doctor if you have: signs of a new infection - fever, sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss; trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or. Your name may be listed on a registry to track any effects of antiviral medicine on the baby. The significance of these weight changes is uncertain, and further evaluation is necessary. Subscribe to BioPharma Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, Carmot Therapeutics Appoints Michael Gray as Chief Financial Officer and Chief Operating Offic, Nano Imrad Technology (NIT) Announces Availability Of Actinium-225, Pioneering A New Era Of Ca, Digital analytics driving optimum HCP engagement: New survey insights, Dr.Evidence Appoints Ken Kobayashi, MD, FACP to its Medical Strategy Advisory Board ("MSAB"), By signing up to receive our newsletter, you agree to our, With todays approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide,". Store Descovy in the original container at room temperature, away from moisture and heat. For more information on the use of Descovy during pregnancy, please refer to the, If you are breast/chestfeeding or plan to breast/chestfeed. | 2 p.m. The approval was granted to Gilead Sciences. headache, dizziness, feeling depressed or tired; This is not a complete list of side effects and others may occur. Descovy is taken daily by patients who do not have the virus. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Descovy is manufactured by Gilead Sciences. FDA APPROVAL DATE DESCOVY was approved by the US Food and Drug Administration on April 4, 2016 . Descovy for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Morning Rundown: Student loan debt bill vetoed, Florida shooting suspects behavior, Bobs Burgers actor arrested, August vote in favor of Descovy as a pre-exposure prophylaxis medication, or PrEP, 'Demisexual,' 'biromantic': LGBTQ youth adopting wide array of labels, Ocasio-Cortez slams Gilead over HIV drug prices: 'People are dying for no reason', a generic version of Truvada would hit the market in September 2020, promised to donate 2.4 million bottles annually, CEO behind HIV drug Truvada grilled on $3B in profits, HIV activists like the PrEP4All coalition. You must be HIV-negative and an adult to use this medicine for this purpose. Importantly, there have been no large studies of PrEP 2-1-1 using Descovy, so people preferring 2-1-1 dosing are encouraged to continue using Truvada, which has been well-studied. Closing ASCO: AstraZenecas very special meeting, more CAR-T survival data and Pfizers PARP play, With new startup Bitterroot, Forty Seven founder takes aim at heart disease, Merck sues to block Medicare negotiation of drug prices, Antibiotic maker Paratek, low on cash, agrees to a buyout, Extending Genetic Services Across Clinical Specialties to Improve Proactive Care, The latest developments on the gene therapy frontier, AstraZenecas Japan Partner to Go Solo on Future Cancer Drugs, Eisai hit with ransomware attack, launches investigation into possible data leaks, CEO of Germanys Merck: decoupling from China would be at huge economic cost, Telegenetics and the Changing Needs of Biopharma Clinical Trials, How to Increase Long-Term Research Participant Engagement. people taking F/TAF had an average 4% rise in LDL , while those taking F/TDF experienced no rise in LDL. If you have taken too much Descovy, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room. Gilead Sciences Statement on Recent Events in Washington, D.C. Gilead Announces New Arm of HIV Womens Prevention Study to Evaluate the Investigational Long-Acting HIV-1 Capsid Inhibitor Lenacapavir in Addition to Descovy for PrEP, Gilead Sciences Statement on The World Health Organizations Updated Veklury (Remdesivir) COVID-19 Treatment Guidelines, https://www.businesswire.com/news/home/20191003005779/en/, DESCOVY FOR PrEP is contraindicated in patients with unknown or positive HIV status, Use DESCOVY FOR PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs), Some HIV tests may not detect acute HIV infection. Take the missed dose as soon as you remember. The component drugs in Descovy, emtricitabine and tenofovir AF, are nucleoside reverse transcriptase inhibitors (NRTIs). in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg. It's a good option for people at risk of getting HIV from sex or injection drug use. Descovy is also used for PrEP to prevent HIV infection. Gilead now controls the U.S. HIV pre-exposure prophylaxis market with two separate drugs: Truvada and Descovy, a smaller and safer pill. Do not use Descovy if the original seal over the container opening is broken or missing. PrEP 2-1-1, which involves taking Truvada for PrEP around the times of anal sex instead of daily, has been well evaluated and is in wide use in Europe and elsewhere. San Francisco AIDS Foundation is a California nonprofit public benefit corporation which has been granted tax exempt status under Internal Revenue Code section 501(c)(3). Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Do not change your dose or dosing schedule without your doctor's advice. FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 3, 2019-- in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. Tell your doctor if you are pregnant, and use your medications properly to control your infection. These are not all the possible side effects of Descovy. The FDA approved the supplemental New Drug Application (sNDA) for Descovy under a priority review designation. The final approval follows an August vote in favor of Descovy as a pre-exposure prophylaxis medication, or PrEP, by an FDA advisory panel. A lack of clinical efficacy data prevented the FDA from recommending F/TAF as PrEP to people who may be exposed to HIV vaginally. SFAF offers daily PrEP and PrEP 2-1-1 dosing options. These data, which were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), included 5,387 individuals who were randomized 1:1 to receive either Descovy or Truvada. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Descovy is a smaller pill than Truvada. You may need frequent liver function tests while using this medicine and for several months after your last dose. You will need frequent medical tests to check your kidney and liver function, or your bone mineral density. Courts Allowed to Ban Mife Today, Viagra Tomorrow? Another possible side effect of Descovy is a change in your immune system (called immune reconstitution inflammatory syndrome or IRIS). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The flu-like symptoms of a new HIV infection may include tiredness, fever, nighttime sweating, rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat, or enlarged. Throw away Descovy that is no longer needed or expired (out of date). Descovy is FDA-approved for use in combination with . Yes, Descovy (emtricitabine and tenofovir alafenamide) is used as a treatment for HIV infection, the virus that can cause acquired immunodeficiency syndrome (AIDS). All Rights Reserved. The U.S. Food and Drug Administration today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1. Keep Descovy in the container that it came in and keep the container tightly closed. Do not have unprotected sex or share razors or toothbrushes. EXECUTIVE SUMMARY Higher efficacy has buoyed hopes for the outlook of Gilead's new TAF-based drugs. Descovy for PrEP provides a new HIV prevention option that matches Truvadas high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time, said Daniel ODay, Chairman and Chief Executive Officer, Gilead Sciences. Using this medicine will not prevent your disease from spreading. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. Take Descovy once each day with or without food. Key takeaways: PrEP pre-exposure prophylaxis is a medication that can prevent you from getting an HIV infection. Descovy combines TAF with another compound,emtricitabine, and is taken in a single tablet. There are no clinical data to support the use of F/TAF for PrEP in cisgender women, transmasculine individuals and other individuals who have receptive vaginal sex, since the DISCOVER study did not include cisgender women or transmasculine people in the trial. 2. San Francisco AIDS Foundation promotes health, wellness and social justice for communities most impacted by HIV through sexual health and substance use services, advocacy, and community partnerships. Get your prescription refilled before you run out of medicine completely. Descovy for PrEP provides a new HIV prevention option that matches Truvadas high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time, said Daniel ODay, Chairman and Chief Executive Officer, Gilead Sciences. U.S. Food and Drug Administration Approves Descovy (Emtricitabine, Tenofovir Alafenamide), Gilead's Third TAF-Based HIV Therapy - Fixed-Dose Combination HIV Treatment Backbone Can Be Paired with Range of Third Agents - Gileads longstanding patient support offerings in the United States include the co-pay coupon program for eligible commercially insured individuals; the Medication Assistance Program (MAP), which provides free medication for those who qualify based on financial need; and the Uninsured 24/7 portal, which provides access to MAP enrollment and free medication that can be accessed from a pharmacy within hours. This is because Descovy has not been studied in people assigned female at birth who are at risk of getting HIV from vaginal sex. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, and new or worsening kidney problems, including kidney failure.. IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR DESCOVY FOR PREP. Version: 13.02. 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