Gilead Sciences, Inc. (GILD - Free Report) announced positive 96-week results from a phase III study on Biktarvy.
The phase III randomized, double-blinded study (Study 1489) evaluated the safety and efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults.
The results from the ongoing study showed that Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) through 96 weeks of therapy. At week 96, non-inferiority was maintained from the primary endpoint measurement at week 48, with 87.9% (n=276/314) of patients taking Biktarvy and 89.8% (n=283/315) of patients taking ABC/DTG/3TC achieving HIV-1 RNA levels less than 50 copies/mL (difference: -1.9 percent, 95 percent CI: -6.9 percent to 3.1 percent, p=0.45). Biktarvy was well tolerated through 96 weeks.
The data will be presented during a late-breaking abstract session at the IDWeek 2018 conference in San Francisco.
The study is ongoing and will remain randomized and blinded through 144 weeks.
We remind investors that Biktarvy is approved in the United States as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history, or as a replacement for the current antiretroviral regimen in those adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. The European Commission also granted marketing authorization to Biktarvy in June 2018.
Gilead is a dominant player in the HIV market with an impressive portfolio for the same. HIV is one of the primary areas of focus for Gilead and the company is working to bring new HIV treatments to market, in order to further boost sales of the franchise. The company was the first to bring to market a single-tablet regimen (STR) for the treatment of HIV — Atripla. The TAF-based products, Genvoya, Odefsey and Descovy, are performing well with strong adoption in both the United States and Europe.
Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (“INSTI”), bictegravir with the demonstrated safety and efficacy profile of the Descovy, (FTC/TAF) which is a dual nucleoside reverse transcriptase inhibitor (“NRTI”) backbone. The combination produced the smallest INSTI-based triple-therapy STR. Biktarvy is expected to pose stiff competition to GlaxoSmith’s (GSK - Free Report) existing therapies, Tivicay and Triumeq.
Meanwhile, Gilead is banking on its HIV franchise to drive growth in future, given the persistent decline in HCV sales. The company’s stock has gained 9.4% in the year so far against the industry's decline of 4.6%.
Gilead’s HCV franchise is experiencing slowdown across key markets, including the United States and Europe, reflecting lower sales of Harvoni and Sovaldi as a result of competitive and pricing pressure. We note that Harvoni, Sovaldi and Epclusa face competition from AbbVie’s (ABBV - Free Report) Viekira Pak and Mayret, and Merck’s (MRK - Free Report) Zepatier, among others.
Meanwhile, Gilead is looking at newer avenues to help its top line and solidify its presence in the gene-therapy space. The initial uptake of Yescarta is also encouraging. The company is also intending to foray into the NASH and inflammation market with late-stage candidates — selonsertib and filgotinib.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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