GSK unveils strong showing for twin-drug HIV treatment

pharmafile | February 14, 2017 | News story | Manufacturing and Production, Research and Development GSK, GlaxoSmithKline, HIV, Tivicay 

GlaxoSmithKline has announced strong Phase 3 findings for its own Tivicay (dolutegravir) as part of a twin-drug regimen with J&J’s Edurant (rilpivirine) for the treatment of HIV-1.

The results were released by GSK’s majority owned HIV specialist company ViiV Healthcare, which conducted two 148 week studies to investigate the safety and efficacy of transferring virologically-suppressed patients to the aforementioned two-drug regimen from a three or four drug cocktail treatment. Over 1000 patients participated in the studies, all of whom had reached viral suppression through either a three or four drug regimen or protease inhibitor antiretroviral treatment plan.

The studies found that the two-drug regimen achieved non-inferior viral suppression at four weeks, compared to three or four drug treatments, while adverse event rates comparable between the studies – an issue GSK addressed:

“As would be expected when switching from a stable regimen to a new regimen, more adverse events were reported and led to withdrawal from the study in the dolutegravir and rilpivirine arm (at 21) compared to the CAR arm (at 3),” the company said in its statement.

John C Pottage, Chief Scientific and Medical Officer at ViiV Healthcare, commented on the results: “The results from these studies may change our understanding of how HIV can be managed. For more than 20 years we thought that three or more drugs were required to maintain virologic suppression, but the SWORD studies provide compelling data that suppression may be maintained with a two drug regimen of dolutegravir and rilpivirine. These data mark an exciting first step towards making two drug regimens a reality in HIV treatment.”

GSK’s positive showing in the HIV treatment sphere can be seen as preparation for the company to face off against Gilead, who is expected to reveal Phase II data on its rival HIV medicine bictegravir later this year.

Matt Fellows

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