FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) and Merck & Co Inc.(MRK) announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor.
At 48 weeks, the novel investigational combination maintained a high rate of viral suppression in virologically suppressed adults, a secondary endpoint of the study. Zero participants had a viral load of greater than or equal to 50 copies/mL at Week 48.
In the 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). The median age of participants was 40 years (20-76). Eighteen percent of participants were assigned female at birth, 50% were non-white, and 29% were Latine.
The proportion of individuals with HIV-1 RNA less than 50 c/mL at Week 48 by FDA snapshot algorithm (a secondary endpoint), showed that participants who switched to treatment with once-weekly islatravir and lenacapavir (ISL + LEN) or continued Biktarvy maintained comparable high rates of HIV suppression at Week 48 (94.2% v. 92.3%, respectively). No participants treated with either ISL + LEN or Biktarvy had a viral load of greater than or equal to 50 copies/mL at Week 48.
The company noted that treatment-related-adverse events were experienced by 19.2% of participants in the ISL + LEN group and the most common were dry mouth and nausea. Treatment-related-adverse events were reported by 5.8% of participants in the Biktarvy group (n=3/52). No grade 3 or 4 Treatment-related-adverse events related to the study drug were reported in either treatment group. Two participants discontinued ISL + LEN due to adverse events unrelated to the drug. At Week 48 no significant differences were seen between treatment groups in mean change from baseline in CD4+ T-cell counts or absolute lymphocyte counts. No participants discontinued due to a decrease in CD4+ T-cell or lymphocyte counts.
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