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New PrEP Studies: Long-Acting HIV-1 Capsid
Inhibitor Lenacapavir Every 6 Months
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• During IDWeek 2020, the company announced the addition of a new study arm to the Women's HIV Prevention Study evaluating the use of lenacapavir as an injectable PrEP option administered every six months. An additional lenacapavir for PrEP study in men who have sex with men and persons of trans experience is planned, with a projected trial initiation date of mid-late 2021.
• In addition to the Women's HIV Prevention Study, Dr. Brainard announced the men who have sex with men (MSM) and persons of trans experience lenacapavir for PrEP study, which is exploring sites in a number of countries including South Africa and the U.S., to be conducted in parallel with a similar trial initiation of mid-late 2021
Gilead Announces New Arm of HIV Women's Prevention Study to Evaluate the Investigational Long-Acting HIV-1 Capsid Inhibitor Lenacapavir in Addition to Descovy for PrEP
Foster City, Calif., December 21, 2020 - Gilead recently announced the addition of a new study arm to the Women's HIV Prevention Study evaluating the use of lenacapavir, the company's investigational, long-acting HIV-1 capsid inhibitor, as an injectable PrEP option administered every six months. The planned trial in adolescent girls and young women will also evaluate the use of oral HIV prevention options Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP® and Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP®.
The Women's HIV Prevention Study is being developed in partnership with the U.S. Food and Drug Administration (FDA), and with input from community stakeholders and advocates on best practices for recruitment and implementation. Using an innovative trial design, its primary objectives are to evaluate the efficacy of lenacapavir for PrEP and Descovy for PrEP in adolescent girls and young women at risk of HIV infection, and to estimate the HIV background incidence rate (bHIV) within the regions the trial is being conducted as a control arm.
"We recognize the urgent need for cisgender women to be better represented in HIV clinical trials given the rapid and disproportionate rate of HIV acquisition in this population," said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences, during a presentation at IDWeek2020. "We are pleased to have aligned with the FDA on a study design to not only examine the use of Truvada and Descovy as potential prevention strategies in cisgender women, but also to start the first-ever trial for use of a six-month dosed long-acting injectable as an HIV prevention method in cisgender women. The trial design is rooted in our belief that science is better when everyone has a seat at the table and reflects a truly collaborative approach with global stakeholders who are uniquely positioned to understand the needs of their local communities."
Gilead is conducting the Women's HIV Prevention Study in Sub-Saharan Africa and will initiate enrollment of cisgender adolescent girls and young women at multiple sites in Uganda and South Africa. Gilead is collaborating with regulatory authorities, Ministry of Health officials, and the HIV scientific and advocacy leadership in these communities on key elements of the study, including site selection, recruitment, protocol development, and ongoing study management.
In addition to the Women's HIV Prevention Study, Dr. Brainard announced the men who have sex with men (MSM) and persons of trans experience lenacapavir for PrEP study, which is exploring sites in a number of countries including South Africa and the U.S., to be conducted in parallel with a similar trial initiation of mid-late 2021.
Lenacapavir is an investigational agent that is also being developed as a component of a long-acting regimen in combination with other antiretroviral agents for treatment of HIV-1 infection. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from the ongoing Phase 1 study support subcutaneous every-six-month administration of lenacapavir for both HIV treatment and prevention. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not known.
For information about the approved uses and important safety information for Descovy (emtricitabine and tenofovir alafenamide; 200/25 mg), and Truvada (emtricitabine and tenofovir disoproxil fumarate; 200/300 mg), please see the full Prescribing Information including BOXED WARNINGS, available at Gilead.com.
Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy®, Descovy for PrEP® and Truvada for PrEP®.
There is no cure for HIV or AIDS.
Full press release link with indications, safety etc:
https://www.gilead.com/news-and-press/company-statements/gilead-announces-new-arm-of-hiv-womens-prevention-study
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