{"id":70785,"date":"2026-07-28T18:15:06","date_gmt":"2026-07-28T10:15:06","guid":{"rendered":"https:\/\/flcube.com\/?p=70785"},"modified":"2026-07-28T18:15:07","modified_gmt":"2026-07-28T10:15:07","slug":"gsks-dovato-demonstrates-non-inferior-efficacy-to-biktarvy-in-phase-iiib-vogue-hiv-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=70785","title":{"rendered":"GSK’s Dovato Demonstrates Non-Inferior Efficacy to Biktarvy in Phase IIIb VOGUE HIV Study"},"content":{"rendered":"\n

GlaxoSmithKline plc<\/strong> (GSK) (NYSE: GSK<\/a>) announced results from the Phase IIIb VOGUE study<\/strong> conducted by its affiliate ViiV Healthcare<\/strong>, demonstrating that Dovato (dolutegravir\/lamivudine)<\/strong> achieved non-inferior efficacy<\/strong> compared to Biktarvy (bictegravir\/emtricitabine\/tenofovir alafenamide)<\/strong> in treatment-na\u00efve adults living with HIV<\/strong>, including those with high viral loads or low CD4+ cell counts<\/strong>.<\/p>\n\n\n\n

Study Overview<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Sponsor<\/strong><\/td>ViiV Healthcare (GSK affiliate)<\/td><\/tr>
Study Name<\/strong><\/td>VOGUE (Phase IIIb)<\/td><\/tr>
Patient Population<\/strong><\/td>Treatment-na\u00efve adults with HIV-1 infection<\/td><\/tr>
Comparator<\/strong><\/td>Dovato vs. Biktarvy<\/td><\/tr>
Primary Endpoint<\/strong><\/td>Virologic suppression (HIV-1 RNA <50 copies\/mL) at Week 48<\/td><\/tr>
Non-inferiority Margin<\/strong><\/td>Pre-specified margin met<\/td><\/tr>
Study Date<\/strong><\/td>Results announced 27 Jul 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 Week 48 Results<\/h2>\n\n\n\n
Parameter<\/th>Dovato (n=254)<\/th>Biktarvy (n=255)<\/th>Difference<\/th><\/tr><\/thead>
Virologic Suppression Rate<\/strong><\/td>89% (226\/254)<\/td>92% (235\/255)<\/td>-3%<\/td><\/tr>
95% Confidence Interval<\/strong><\/td>\u2013<\/td>\u2013<\/td>[-8%, 2%]<\/td><\/tr>
Median Time to Suppression<\/strong><\/td>4.1 weeks<\/td>4.1 weeks<\/td>Similar<\/td><\/tr>
Treatment-Emergent Resistance<\/strong><\/td>None identified<\/td>None identified<\/td>No difference<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The study successfully met its non-inferiority endpoint<\/strong> with the adjusted treatment difference of -3%<\/strong> falling within the pre-specified non-inferiority margin. Both regimens demonstrated rapid viral suppression<\/strong> with identical median time to suppression of 4.1 weeks<\/strong>.<\/p>\n\n\n\n

Drug Profile Comparison<\/h2>\n\n\n\n

Dovato (dolutegravir\/lamivudine)<\/h3>\n\n\n\n