Promising HIV Treatment: Phase 2 Clinical Trial Success for Gilead's and Merck's Combo Therapy

Zinger Key Points
  • Merck/Gilead's investigational combination Regimen has the potential to be the first oral weekly HIV treatment.
  • The results support continued development as a potential Long-Acting Oral Combo therapy option for Virologically Suppressed HIV patients.

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. 

Also Read: Crucial Battle Over Healthcare Mandates: Biden Administration Defends Preventive Care Coverage Amidst Legal Challenges.

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 NextPfizer/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.

HIV/AIDS ribbon via Shutterstock

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsStories That Matter
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!