Gilead's Descovy Nears FDA Approval for HIV PrEP in Men, Gender-Specific Efficacy Data Sparks Debate

Compiled by: Fan Dongdong

Recently, the U.S. FDA has been actively discussing the efficacy of Gilead’s Descovy for pre-exposure prophylaxis (PrEP) against HIV infection. However, what intrigues the public most is not whether the drug will be approved for male patients, but rather whether the FDA will also give the green light for its use in female patients.

The briefing document on Descovy recently released by the FDA shows that,Reviewers stated that this review primarily targeted two groups: men who have sex with men and men who have sex with transgender women.Gilead’s submitted data support the use of Descovy for pre-exposure prophylaxis (PrEP) against HIV infection in these two populations.

The data submitted herein are derived from a two-year, randomized, controlled, double-blind Phase III clinical study evaluating the safety and efficacy of once-daily Descovy and Truvada for pre-exposure prophylaxis (PrEP) against HIV. The study enrolled men who have sex with men (MSM) and men who have sex with transgender women, all of whom were at high risk of HIV infection.

The results showed that,Descovy and Truvada Achieved Non-Inferiority Endpoints for Pre-Exposure Prophylaxis Against HIV Infection, indicating no significant differences between the two groups in terms of HIV infection risk factors, acquired sexually transmitted infections, and adherence. Furthermore, Descovy demonstrated a faster onset of action than Truvada, achieving effective intracellular drug concentrations more rapidly, and additional pharmacokinetic data confirmed that drug concentration levels were maintained for a longer duration in patients receiving Descovy compared to those receiving Truvada.

SVB Leerink analyst Geoffrey Porges wrote in a report to clients, “Based on the briefing documents released by the FDA, Descovy will clearly be approved for pre-exposure prophylaxis (PrEP) against HIV infection in men.” Men constitute the largest consumer segment in the PrEP market. Currently, most men choose Truvada for PrEP; however, as Truvada approaches the end of its patent exclusivity period, Gilead Sciences is actively seeking approval for new drugs to replace it.

Porges also pointed out that FDA regulators appear uncertain about the efficacy of Descovy for pre-exposure prophylaxis (PrEP) in female patients, as Gilead’s trial data included only men and transgender women, lacking comprehensive data on all female populations. Whether Descovy will ultimately gain approval for other types of women depends on whether the FDA considers external pharmacokinetic studies sufficient to infer that the drug is effective in preventing HIV infection in these additional female groups.

HIV-1 is the primary cause of HIV infection worldwide. Descovy has previously been approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients aged 12 years and older. Currently, Truvada is the only medication approved for pre-exposure prophylaxis (PrEP) against HIV. In May of this year, Gilead Sciences committed to donating 2.4 million bottles of Truvada to the U.S. government, primarily aimed at controlling disease progression and preventing new infections. However, some media outlets have suggested that the underlying motive was to stifle competition from generic drugs. Gilead Sciences has further pledged to donate Descovy to the U.S. government should the FDA approve it for HIV prevention.

If Descovy is approved this time, it will be good news for Gilead to achieve its sales target for HIV drugs. Porges predicts that the peak sales of Descovy will reach $3.8 billion, which should be enough to offset the sales crisis faced by Truvada.

Reference Source: Gilead's Descovy Seems Set for a PrEP Nod in Men, FDA Review Shows. But What About Women?