Gilead Sciences Reports Long-Term Efficacy and Safety of Descovy for PrEP and Biktarvy in HIV Treatment

Today, Gilead Sciences, Inc. announced that Descovy, used as pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in men and transgender women, and Biktarvy, used for the treatment of patients with initial HIV infection, have further demonstrated their long-term efficacy and safety in extension studies of Phase 3 trials. These data were presented at the 17th European AIDS Conference (EACS) held in Basel, Switzerland.

AIDS is an infectious disease caused by HIV infection. The development of modern antiretroviral drugs and the rise of “cocktail therapy” have enabled patients with HIV to control the condition long-term and achieve a life expectancy comparable to that of the general population. Recent studies have found that taking antiretroviral medications before exposure can reduce the risk of HIV infection. This preventive approach is known as PrEP (Pre-Exposure Prophylaxis).

Gilead’s next-generation anti-HIV drug, Descovy (emtricitabine 200 mg, tenofovir alafenamide 25 mg), was first approved in 2016 for use in combination with other antiretroviral agents to treat patients with HIV infection. Earlier this year, it received approval for an expanded indication as pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in HIV-negative adults and adolescents weighing at least 35 kg who are at risk through sexual exposure. The indicated population excludes individuals engaging in receptive vaginal sex.

The DISCOVER trial aimed to verify whether Descovy could meet the non-inferiority criteria compared to Truvada, an approved PrEP regimen. Truvada is a previous-generation antiviral drug developed by Gilead Sciences, Inc., and has received FDA approval for HIV pre-exposure prophylaxis (PrEP). The 96-week results of the DISCOVER trial confirmed the previously observed non-inferiority, with an average annual HIV incidence rate of 0.16 per 100 person-years in the Descovy group versus 0.30 per 100 person-years in the Truvada group. Furthermore, Descovy demonstrated long-term safety in terms of bone mineral density and renal function.

Diana Brainard, Ph.D., Senior Vice President of HIV and Emerging Viruses at Gilead Sciences, stated, “The 96-week data from the DISCOVER trial further support that Descovy has comparable efficacy to Truvada as pre-exposure prophylaxis (PrEP) and provide new insights into improved renal and bone safety. As an increasing number of high-risk individuals use PrEP over extended periods, these data confirm the value of Descovy as a next-generation PrEP regimen for HIV prevention.”

Compared with Descovy, Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg) contains the additional component bictegravir. This is a novel integrase strand transfer inhibitor (INSTI).

In Studies 1489 and 1490, the efficacy of Biktarvy in suppressing HIV was evaluated in treatment-naïve adults with HIV-1 infection, compared with dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or DTG plus Descovy, respectively.

The 144-week trial results showed that 82% of patients receiving Biktarvy achieved an HIV-1 RNA level of <50 copies/mL, meeting the non-inferiority criteria for suppression of viral replication compared with DTG/ABC/3TC (84%) and DTG + Descovy (84%). Furthermore, no patients in any treatment group experienced treatment failure due to drug resistance.

Diana Brainard, Ph.D., Senior Vice President of HIV and Emerging Viruses at Gilead Sciences, stated, “The latest findings on Biktarvy support its ability to provide durable viral suppression and its efficacy in preventing the emergence of drug resistance. These long-term data, spanning nearly three years, further confirm the sustained efficacy of Biktarvy as a first-line therapy for treatment-naïve adults with HIV infection.”

References:

[1] Gilead Presents 96-week Discover Trial Data Supporting Non-inferior Efficacy and Key Safety Differences of Descovy For PrEP™ Compared With Truvada For PrEP®. Retrieved Nov. 6, 2019, from https://www.businesswire.com/news/home/20191106005417/en

[2] Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials. Retrieved Nov. 6, 2019, from https://www.businesswire.com/news/home/20191106005418/en

[3] U.S. FDA Approves Gilead’s New Drug for the Treatment of HIV-1 Infection. Retrieved Nov. 6, 2019, from https://mp.weixin.qq.com/s/RdReI2Cdkux-doHRmG40IQ

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