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GSK Unit Says Dovato 'Non-Inferior' to Biktarvy in Phase 4 HIV Study
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GSK Unit Says Dovato 'Non-Inferior' to Biktarvy in Phase 4 HIV Study
Jul 23, 2024 10:22 AM

12:56 PM EDT, 07/23/2024 (MT Newswires) -- GSK (GSK) said Tuesday that its ViiV Healthcare subsidiary's phase 4 clinical trial showed that the two-drug regimen Dovato has "non-inferior efficacy" compared with the three-drug regimen Biktarvy in people living with human immunodeficiency virus-1, or HIV-1.

The study compared Dovato, or dolutegravir and lamivudine, with the Biktarvy regimen, or bictegravir/emtricitabine/tenofovir alafenamide fumarate, as HIV-1 treatment for people who are virologically suppressed and who could benefit from treatment optimization, the company said.

The study met its primary endpoint, with Dovato showing "non-inferior efficacy" in maintaining viral suppression compared with switching to Gilead Sciences' ( GILD ) Biktarvy at 48 weeks, the company added.

The study also showed in a secondary endpoint that "weight increased significantly" in patients who switched to Biktarvy than in those who took Dovato, according to GSK.

ViiV, which GSK owns with partners Pfizer ( PFE ) and Shionogi, is expected to present the results of its phase 4 study at an international conference Thursday.

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