Gilead, MRK Report Data From Investigational Combination Study for HIV

Gilead Sciences, Inc. GILD and partner Merck MRK announced new results from a mid-stage study evaluating the investigational combination of islatravir and lenacapavir for the treatment of HIV.Data showed a treatment switch to an investigational oral once-weekly combination regimen of islatravir and lenacapavir maintained viral suppression in adults at week 48.Shares of the company have risen 6.2% year to date against the industry’s decline of 1.7%.Image Source: Zacks Investment ResearchData From GILD and MRK’s Combo StudyThe phase II study is evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor.This open-label, active-controlled study enrolled virologically suppressed adults who were on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF).Biktarvy is Gilead’s once-a-day single tablet, which is used to treat HIV-1 in adults and children.These patients were randomly allocated in two arms equally 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).The novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression in virologically suppressed adults, a secondary endpoint of the study at 48 weeks. None of the participants had a viral load of ≥50 copies/mL at week 48.The proportion of individuals with HIV-1 RNA <50 c/mL at week 48 by FDA snapshot algorithm showed that participants who switched to treatment with once-weekly islatravir and lenacapavir or continued Biktarvy maintained comparable high rates of HIV suppression at week 48. No participant treated with either the combination regimen or Biktarvy had a viral load of ≥ 50 copies/mL at week 48 (another secondary endpoint).However, treatment-related-adverse events (TRAEs), as attributed by the study investigator, were experienced by 19.2% of participants in the combination arm. TRAEs were reported by only 5.8% of participants in the Biktarvy group.While Biktarvy has greatly helped to transform HIV care, novel HIV treatment options that allow for less frequent oral dosing have the potential to help support adherence.Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1.Gilead’s Dominant Position in the HIV SpaceGilead is a dominant player in the HIV market. The company developed the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP), to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice yearly.Approval of additional treatments should further bolster its franchise.Please note that lenacapavir is already approved under the brand name Sunlenca in the United States for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant infection.GILD is evaluating twice-yearly lenacapavir for the prevention of HIV as PrEP.  The company recently reported positive data from a second phase III study evaluating lenacapavir for the prevention of HIV.The strong results increase the probability of lenacapavir’s approval that should further solidify GILD’s HIV franchise.GSK GSK is a key competitor for GILD in the HIV market. The company posted 13% growth in HIV sales in the second quarter, driven by strong patient demand for two drug regimens — Dovato and Juluca — and long-acting drugs (Cabenuva and Apretude).GILD’s Zacks Rank & Stock to ConsiderGilead currently carries a Zacks Rank #3 (Hold). A better-ranked biotech from the sector is Alnylam Pharmaceuticals ALNY, which currently carries a Zacks Rank #2 (Buy).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 cents to 26 cents during the same period. Year to date, shares of ALNY have risen 55%. Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks