On Saturday, Gilead Sciences, Inc. GILD and Merck & Co. Inc. MRK revealed new results from a Phase 2 clinical study evaluating the investigational combination of islatravir and lenacapavir.
The data was presented at the ID Week 2024.
At 48 weeks, the investigational combination maintained a high rate (n=49; 94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults, a secondary endpoint of the study.
Also Read: Gilead Sciences Faces Wall Street Speculation About Obesity Drugs Despite Focus On Liver Treatments.
Zero participants had a viral load of ≥50 copies/mL at Week 48.
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).
The proportion of individuals with HIV-1 RNA <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 ISL + LEN or Biktarvy had a viral load of ≥ 50 copies/mL at Week 48 (another secondary endpoint).
19.2% of participants (n=10/52) in the ISL + LEN group experienced treatment-related adverse events (TRAEs), and the most common were dry mouth (n=2/52; 3.8%) and nausea (n=2/52; 3.8%).
TRAEs were reported by 5.8% of participants in the Biktarvy group (n=3/52).
No grade 3 or 4 TRAEs related to the study drug were reported in either treatment group.
In March, the companies released 24-week data from the Phase 2 study of 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.
Price Action: GILD stock was down 0.59% at $86.21, and MRK is down 1.19% at $107.25 at last check Monday.
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