Gilead Sciences Inc GILD and Merck & Co Inc MRK released results from the Phase 2 clinical study evaluating the combination of islatravir and lenacapavir for HIV infection.
At 24 weeks, the investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL), which is a secondary endpoint of the study.
Results of the primary endpoint (HIV-1 RNA ≥50 copies/mL (c/mL) showed that one participant (1.9%) treated with islatravir and lenacapavir had a viral load of >50 copies/mL at Week 24; the participant later suppressed on islatravir and lenacapavir at Week 30.
The potent antiviral activities and pharmacokinetic profiles of islatravir and lenacapavir support their development as an investigational once-weekly oral combination regimen.
In this open-label, active-controlled study, virologically suppressed adults (n=104) on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) were randomly allocated in a 1:1 ratio to receive either oral islatravir 2 mg and lenacapavir 300 mg once a week (n=52) or to continue daily oral Biktarvy (n=52).
No participants in the Biktarvy group had a viral load of more than 50 copies/mL at Week 24.
Results of the secondary endpoint, as measured by the proportion of individuals with HIV-1 RNA < 50 c/mL at Week 24, showed that participants who switched to treatment with once-weekly islatravir and lenacapavir or continued Biktarvy both maintained comparable high rates of HIV suppression at Week 24 (94.2% v. 94.2%).
Grade 1 and 2 treatment-related adverse events reported in the islatravir and lenacapavir group included dry mouth and nausea (each 3.8%).
No grade 1 and 2 TRAEs were reported in the Biktarvy group.
The Phase 2 study will continue in an open-label fashion through Week 48. Longer-term data will be presented at a future scientific conference.
Read Next: Pfizer/GSK-Backed ViiV Healthcare’s HIV Drug Associated With Increased Resistance, WHO Report Says.
Price Action: GSK shares closed up 0.05% at $42.62, and MRK stock up 0.75% at $123.75 on Wednesday.
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