▎WuXiEdited by Kant Content Team

Gilead Sciences and MSD announced today the latest results of a phase 2 clinical trial for the long-acting HIV oral combination therapy islatravir and lenacapavir. The results showed that at 24 weeks,This innovative combination maintains a high rate (94.2%) of viral suppression in HIV patients.(HIV-1 RNA <50 copies/mL). The press release noted that the trial results showed,This innovative combination has the potential to become the first once-weekly oral combination therapy for HIV treatment.Once-daily oral therapy has revolutionized HIV treatment, and options that reduce dosing frequency may address some daily...TakeChallenges in medication adherence, stigma, and other issues faced by individuals on oral antiretroviral therapy.

The primary endpoint result was the number of patients with HIV-1 RNA ≥50 copies/mL at Week 24. Data showed that one participant (1.9%) receiving islatravir and lenacapavir had viral levels exceeding 50 copies/mL at Week 24; this participant’s viral levels were suppressed by Week 30. In the Biktarvy group, no participants had viral levels exceeding 50 copies/mL at Week 24. The secondary endpoint was the proportion of individuals with HIV-1 RNA <50 copies/mL at Week 24, and results showedParticipants who switched to weekly islatravir and lenacapavir treatment or continued Biktarvy treatment maintained a high HIV suppression rate (94.2% vs. 94.2%) at week 24.

In terms of safety, grade 1 and 2 treatment-related adverse events (TRAEs) reported in the islatravir and lenacapavir groups included dry mouth and nausea (each 3.8%). No grade 1 or 2 TRAEs were reported in the Biktarvy group. Neither treatment group reported any grade 3 or 4 TRAEs related to the study drugs. This Phase 2 clinical trial will continue in an open-label manner until Week 48. Long-term data will be presented at future scientific conferences.

Lenacapavir (brand name Sunlenca) is a "first-in-class" long-acting HIV capsid inhibitor, indicated for use in combination with other antiretroviral drugs for the treatment of multidrug-resistant HIV infection in adult patients. It has received regulatory approval in multiple countries and regions. Islatravir (MK-8591) is a nucleoside reverse transcriptase translocation inhibitor under evaluation by Merck & Co., Inc., intended for use in combination with other antiretroviral drugs for the treatment of HIV-1.

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