Gilead Presents New Pharmacokinetic Data Showing Descovy's Superior Profile Over Truvada for HIV Pre-Exposure Prophylaxis

July 24, 2019/BioonBIOON/--U.S. pharmaceutical giant Gilead Sciences recently at the 2019 International AIDS Society Conference on HIV Science held in Mexico CityConference(IAS 2019) announced new data from the DISCOVER clinical study on HIV pre-exposure prophylaxis (PrEP).

This was a 2-year, randomized, controlled, double-blind Phase III study evaluating the safety and efficacy of once-daily Descovy (Chinese brand name: Dakewei; F/TAF; emtricitabine/tenofovir alafenamide, 200/25 mg) versus Truvada (Chinese brand name: Shufatai; F/TDF; emtricitabine/tenofovir disoproxil fumarate, 200 mg/300 mg) for HIV pre-exposure prophylaxis (PrEP). The study enrolled adult men and transgender women who have sex with men at significant and ongoing risk of acquiring HIV through sexual contact.

The results demonstrated that Descovy and Truvada met the non-inferiority endpoint for HIV pre-exposure prophylaxis (PrEP). There were no differences between the two drug groups in terms of HIV risk factors, acquisition of sexually transmitted infections (STIs), or adherence. However, subgroup analysis revealed that Descovy achieved intracellular drug concentrations more rapidly than Truvada, and additional pharmacokinetic data confirmed that drug concentration levels with Descovy persisted longer than those with Truvada.

Specific data showed that the time to reach 90% effective concentration (EC90) of tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) was significantly shorter in the Descovy group than in the Truvada group. At Week 4, TFV-DP levels in PBMCs in the Descovy group were 6.3-fold higher than those in the Truvada group. In the Descovy group, 98% of participants maintained drug levels above EC90, compared with only 68% in the Truvada group. Pharmacokinetic data from a separate PK study indicated that, after 14–28 days of dosing, the duration during which TFV-DP levels remained above EC90 after discontinuation of Descovy was at least 60% longer than that observed with Truvada. Lower concentrations of TFV-DP in PBMCs are associated with an increased risk of HIV infection; these data support the potential of Descovy for use in pre-exposure prophylaxis (PrEP).

Data released this March show that Descovy is as effective as Truvada for PrEP, with a better safety profile for bones and kidneys. Descovy will provide an important new preventive treatment option for people at high risk of HIV.

Regarding indications, Truvada has been approved for: (1) treatment of HIV-1 infection in adults in combination with other antiretroviral agents; and (2) reduction of the risk of sexually acquired HIV-1 infection in high-risk HIV-negative adults when used in conjunction with safer sex practices (such as condom use), known as pre-exposure prophylaxis (PrEP). In contrast, Descovy is only approved for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents and has not yet been approved for PrEP.

In China, Descovy (F/TAF, 200/10 mg and 200/25 mg) was approved in December 2018, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and adolescents (aged ≥12 years and weighing ≥35 kg).

Descovy is a fixed-dose combination tablet composed of emtricitabine (F) and tenofovir alafenamide fumarate (TAF). TAF is a novel nucleoside reverse transcriptase inhibitor (NRTI) and an upgraded version of Gilead’s marketed drug Viread (tenofovir disoproxil fumarate, TDF). InClinical TrialsTAF has been proven to exhibit highly potent antiviral efficacy at one-tenth the dose of TDF, while demonstrating a superior safety profile with improved renal and bone safety parameters. (Bioon.com)

Original Source:Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada®