Dovato shows comparable efficacy to Biktarvy with less weight gain

DURHAM - ViiV Healthcare, a subsidiary of GSK (NYSE: GSK), announced positive results for its HIV treatment Dovato. The announcement comes as GSK, a prominent player in the pharmaceuticals industry with a market cap of $86.6 billion, continues to demonstrate strong financial health. According to InvestingPro analysis, GSK maintains an impressive 71.7% gross profit margin and is currently trading near its 52-week high. The company’s Dovato demonstrated non-inferior efficacy compared to Biktarvy in maintaining viral suppression in adults with HIV-1 over a two-year period, according to 96-week data from the PASO DOBLE clinical trial.

The phase IV randomized study, involving 553 virologically suppressed adults who switched from prior HIV treatments, showed that patients taking Dovato experienced statistically significant less weight gain and fewer drug-related adverse events than those taking Biktarvy. With GSK’s upcoming earnings report scheduled for October 29, investors following this development can access comprehensive analysis through InvestingPro’s detailed research reports, which offer expert insights on the company’s pipeline and market position.

Results presented at the European AIDS Clinical Society annual congress showed that mean adjusted weight gain was 0.84kg with Dovato compared to 2.35kg with Biktarvy through week 96, representing a difference of 1.52kg. Additionally, 20.1% of Dovato patients experienced weight increases greater than 5% versus 34.8% of those on Biktarvy.

Drug-related adverse events were less frequent with Dovato (7.6%) than with Biktarvy (13.4%). Six participants discontinued treatment due to adverse events, primarily neuropsychiatric in nature, with no significant differences between the treatment groups.

"For people living with HIV, achieving and maintaining viral suppression remains the cornerstone of effective treatment," said Jean van Wyk, Chief Medical Officer at ViiV Healthcare, in a press release statement. "However, HIV treatment options have now advanced to where we can also look to other health metrics to help define success."

PASO DOBLE is described as the largest head-to-head trial comparing the two-drug regimen Dovato to the three-drug regimen Biktarvy for HIV-1 treatment in virologically suppressed individuals. The study population included people on therapies that could be optimized, such as multiple tablet regimens or those containing drugs with cumulative toxicity.

No resistance was observed in any cases of virological failure during the study period. GSK’s strong market position and financial stability, evidenced by its $43.4 billion in revenue over the last twelve months, suggest continued investment in innovative treatments. For detailed analysis of GSK’s financial health and growth prospects, including 13 additional ProTips, visit InvestingPro.

In other recent news, GSK has received expanded approval from the China National Medical Products Administration for its Shingrix vaccine. This approval allows Shingrix to be used for preventing shingles in adults aged 18 and older who are at increased risk due to immunodeficiency or immunosuppression, marking it as the first vaccine authorized for this specific group in China. Additionally, GSK has announced a significant $30 billion investment in research and development, as well as supply chain infrastructure in the United States over the next five years. This investment will include a $1.2 billion commitment to advanced manufacturing facilities and digital technologies, which is expected to create hundreds of skilled jobs.

GSK also announced the appointment of Luke Miels as CEO designate, effective January 2026, following the planned departure of current CEO Dame Emma Walmsley. Furthermore, the U.S. Food and Drug Administration has approved leucovorin, a form of folic acid, for improving symptoms related to cerebral folate deficiency, which includes autistic features. Meanwhile, Raymond James has reiterated an Outperform rating on Veeva Systems, noting GSK’s successful implementation of Veeva’s Vault CRM across Europe. These developments highlight GSK’s ongoing strategic efforts in vaccine approval, leadership transition, and substantial investments in R&D and infrastructure.

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