Merck Reports Positive Efficacy Data from Phase III HIV Study

Merck and Co.MRK announced positive efficacy results from the phase III DRIVE-AHEAD study, evaluating the efficacy and safety of Delstrigo in treatment-naïve adults with HIV-1 infection.

Delstrigo was approved in August as a once-daily fixed dose triple combination regimen, containing Merck's non-nucleoside reverse transcriptase inhibitor ("NNRTI"), doravirine and other HIV medicines, lamivudine and tenofovir disoproxil fumarate. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also adopted a positive opinion, recommending granting of marketing authorization to Delstrigo in September.

In the DRIVE-AHEAD study, 728 patients, with no antiretroviral treatment history, were randomized to receive at least one dose of either Delstrigo or a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg) once daily. In the study, after 96 weeks of treatment, 77.5% of participants treated with Delstrigo achieved plasma HIV-1 RNA levels less than 50 copies/mL versus 73.6% in the group treated with EFV/FTC/TDF. The efficacy findings were consistent with the findings at Week 48, in which Delstrigo demonstrated non-inferior efficacy compared to EFV/FTC/TDF.

In a separate press release, Merck also presented 96-week data from the phase III DRIVE-SHIFT study, which evaluated the benefit of switching to Delstrigo in adults with HIV-1 infection, who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen. Data from the study showed non-inferior efficacy for those who switched to Delstrigo compared to those who continued with their baseline regimen.

Merck's shares have increased 26.5% so far this year compared with the industry 's growth of 7.1%.

In the HIV market, Gilead Sciences GILD and GlaxoSmithKline GSK dominate with several drug regimens in their portfolios. These drugs generate high revenues, every quarter.

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Zacks Rank & Stock to Consider

Merck currently has a Zacks Rank #3 (Hold).

Bristol-Myers Squibb Co. BMY is a better-ranked stock from the same space, sporting a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Bristol-Myers' earnings per share estimates have increased from $3.59 to $3.62 for 2018 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.39%. Share price of the company has increased 1.8% year to date.

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