Emtricitabine/Tenofovir Disoproxil Fumarate

THURSDAY, Nov. 28, 2024 -- People whose partners have HIV must remember to take antiretroviral pills every single day or risk infection themselves. But researchers have come up with a way to avoid that daily hassle – an injectable drug that patients would only have to receive twice a year. What’s more, the new drug works even better than the currently available pills, clinical trial results show. A twice-yearly injection of Sunlenca (lenacapavir) reduces the risk of HIV infection by 96%, which is significantly more effective than oral pre-exposure prophylaxis (PrEP) using pills like Truvada , researchers report in the New England Journal of Medicine . “Seeing these high levels of efficacy – at almost 100% -- in an injectable that people only have to take every six months is incredible,” lead researcher Dr. Colleen Kelley , a professor of medicine at Emory University, said in a news release. “This is a considerable and profound advancement in medicine, especially for people whose circumstances don’t allow them to take a daily oral medication, and for those among populations disproportionately impacted by HIV,” she added. In the new clinical trial, 99% of the patients receiving Sunlenca did not become infected with HIV, results show. There were only two infections among 2,179 people taking Sunlenca, compared with nine infections among the 1,086 people randomly assigned to take Truvada. Results also showed it was easier for people to stick with the twice-yearly injections than to take a daily pill. Truvada’s effectiveness becomes greatly compromised if it’s taken inconsistently, researchers noted. “What we see over time is that about half of people who start taking daily oral PrEP stop within a year due to various factors,” Kelley said. “Having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing healthcare or staying adherent to daily, oral pills.” People at risk of HIV also tend to be people who have limited access to the pills, or may have trouble taking their meds consistently, researchers said. “We are not reaching everyone we need to reach with our current HIV prevention interventions, such as those who are disproportionately impacted by HIV and health care disparities,” Kelley said. “For people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay HIV negative.” The U.S. Food and Drug Administration approved the drug, marketed as Sunlenca, in December 2022 as a treatment for people with HIV, to help control their infection. These results show that it also could be used by people without HIV to prevent infection, researchers said. The trial data have been submitted to the FDA, and Kelley is hopeful the drug will be approved for this use by 2025. “Long acting antiretrovirals offer new hope for those who are not able to take oral medications,” Dr. Carlos del Rio , chair of medicine at Emory University, said in a news release. “The challenge is now to roll out and make these tools available and accessible in an equitable way — only then we will see new HIV infections dramatically decreased locally and globally.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine ( NEJM ) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. There were two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada ® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for PrEP and was generally well-tolerated, with no significant or new safety concerns identified. The strong efficacy and tolerability of lenacapavir are consistent with previous results from the PURPOSE 1 trial, which demonstrated zero infections and 100% efficacy for the investigational use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa. The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland (HIV Glasgow) earlier this month, the unblinding of the trial at interim analysis in September , and a presentation of additional efficacy and safety data in October at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 1 data were also published by NEJM in conjunction with the full data presentation at the 25 th International AIDS Conference in Munich, Germany (AIDS 2024). Gilead is executing an access strategy, informed by more than 100 global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review and approval of lenacapavir for PrEP in regions around the world. Data from both PURPOSE 1 and PURPOSE 2 will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024. The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications , including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Forward-Looking Statements This statement 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 Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the supply and distribution of lenacapavir, including through direct supply as well as indirect supply through the voluntary licensing agreements, and the ability of the parties to meet potential demand for lenacapavir, in each case, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada, including Boxed Warning, and lenacapavir are available at www.gilead.com . Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).