Results

Merck’s HIV drug doravirine looks solid — though far less stellar than rivals — in 1st PhIII

Merck’s late-stage antiviral doravirine (MK-1439) came through in its first Phase III study, matching up nicely against J&J’s blockbuster Prezista.

The non-nucleoside reverse transcriptase inhibitor compared closely to the rival therapy in the non-inferiority test, adding a positive secondary endpoint on lower LDL levels among patients. The drug used in a cocktail remedy eliminated all signs of the virus among 83.8% (321/383) compared to 79.9% for Prezista (306/383).

Dr. Kathleen Squires, professor and director of infectious diseases, Thomas Jefferson University, Philadelphia, noted:

The results of this study provide solid evidence of the efficacy and safety profile of doravirine as a potential treatment option for treatment-naïve HIV-1 patients.

Merck has had this drug — its only Phase III HIV drug — in the clinic for a number of years now, patiently winding through mid-stage and a set of planned late-stage efforts as it looks for a successor to Isentress, on the market for the past decade while slowly growing annual revenue to $1.4 billion.

Merck’s perfectly respectable showing at a Seattle conference, though, was overshadowed by a heavyweight rivalry between Gilead and GlaxoSmithKline’s ViiV, which each produced stellar data for their late-stage contenders.

Looking to defend itself against a new HIV drug from Gilead, GlaxoSmithKline’s $GSK ViiV posted a near mirror image of viral suppression for its two-drug combo of Tivicay (dolutegravir) tied to J&J’s rilpivirine compared with the results from the three- and four-drug cocktails it hopes to replace. But Gilead $GILDstruck first, releasing the first look at some impressive Phase II data on their rival drug bictegravir. Analysts are waiting for Gilead to come through with Phase III data on bictegravir in Q2.


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