ViiV Healthcare to reveal results from largest head-to-head trial for Dovato vs. Biktarvy at AIDS 2024

ViiV Healthcare, a prominent global HIV specialist company primarily owned by GSK, along with Pfizer and Shionogi as shareholders, will present a significant clinical trial at the upcoming 25th International AIDS Conference in Munich, Germany from July 22 to 26. This presentation will feature the largest head-to-head, randomised clinical trial (RCT) comparing ViiV’s 2-drug regimen, Dovato (dolutegravir/lamivudine [DTG/3TC]), against a 3-drug regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]).

The study, sponsored by the SEIMC-GeSIDA Foundation, examines the efficacy and safety of switching virologically suppressed adults from an established treatment to either Dovato or Biktarvy. Results from the first 48 weeks will be shared, focusing on treatment efficacy, safety, and changes in participants' weight.

Harmony P. Garges, M.D., ViiV Healthcare’s Chief Medical Officer, emphasizes the importance of these findings. Garges notes that people living with HIV seek more treatment options to address needs beyond viral suppression. The head-to-head study between Dovato and Biktarvy, along with other data presented, underscores ViiV Healthcare's leadership in innovative HIV treatments and prevention strategies.

Among the key presentations, notable studies include:

1. PASO-DOBLE Study: This study evaluates the non-inferiority of the 2-drug regimen Dovato compared to the 3-drug regimen Biktarvy in virologically suppressed individuals. Researchers will discuss the 48-week results on efficacy, safety, and weight changes.

2. DYAD Study: This study presents 48-week findings on virologically suppressed participants without prior virologic failure who switched to Dovato or continued on Biktarvy.

3. SOUND Study: This study follows up on virologically suppressed participants with an unknown resistance history who switched from Biktarvy to Dovato, presenting 96-week findings.

In addition to these studies, new data from the HPTN 084 open-label extension study will be unveiled, examining the safety of cabotegravir long-acting (LA) for pre-exposure prophylaxis (PrEP) during pregnancy. This study focuses on maternal, pregnancy, and infant safety outcomes among participants who continued with cabotegravir LA injections during pregnancy.

Moreover, ViiV Healthcare will present phase I findings from VH184, a third-generation integrase inhibitor (INSTI), showing potent activity against multiple INSTI-resistant mutations. This marks the first data presentation of the company's next INSTI as part of its ultra long-acting development strategy.

Real-world evidence from the long-acting treatment regimen cabotegravir + rilpivirine (CAB+RPV LA) will also be featured. This includes perspectives from people living with HIV 12 months after switching to CAB+RPV LA, effectiveness, adherence, and patient-reported outcomes from various cohorts.

Specific studies to be highlighted include:
- BEYOND Study: Observational study on clinical outcomes 12 months post-initiation of CAB+RPV LA.
- CARLOS Study: Effectiveness and adherence outcomes from the German cohort.
- COMBINE-2 Study: Utilization and effectiveness among virologically suppressed, treatment-experienced individuals.

ViiV Healthcare’s commitment to innovative HIV care is further evidenced through presentations on the third-generation INSTI VH184 and other pipeline assets. These studies display the company's ongoing efforts to advance HIV treatment and prevention, ultimately aiming to transform the future of HIV care and help end the epidemic.

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