ViiV's Dovato Shows Lower Steatotic Liver Disease Risk Compared to Biktarvy in HIV Patients
核心洞察
ViiV Healthcare's Dovato demonstrated significantly lower rates of steatotic liver disease (搜索) compared to Gilead's Biktarvy in HIV (搜索) patients after 96 weeks of treatment.
The Phase IV PASO DOBLE study showed 29% of Dovato patients developed steatotic liver disease (搜索) versus 49% of Biktarvy patients, with the most pronounced difference in patients with clinically meaningful weight gain.
The findings highlight important metabolic health differences between two-drug and three-drug HIV (搜索) regimens, providing new insights for treatment selection in virologically suppressed HIV patients.
ViiV Healthcare's two-drug HIV (搜索) regimen Dovato (dolutegravir/lamivudine) demonstrated a significantly lower incidence of steatotic liver disease (搜索) compared to Gilead's three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in virologically suppressed HIV patients, according to 96-week data from the Phase IV PASO DOBLE study presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.
Study Results Show Clear Metabolic Advantage
The sub-analysis of PASO DOBLE (GeSIDA 11720), the largest head-to-head randomized clinical trial comparing the two regimens, included 111 adults living with HIV (搜索) who were virologically suppressed. At 96 weeks, steatotic liver disease (搜索) was observed in 29% of patients who switched to Dovato compared with 49% of those who switched to Biktarvy (p=0.033).
The difference became even more pronounced in patients experiencing clinically meaningful weight gain of ≥5% of baseline body weight. In this subgroup, steatotic liver disease (搜索) was reported in 76% of Biktarvy patients versus only 17% of Dovato patients (p=0.002). No significant change was observed in patients who gained less than 5% of their baseline body weight.
Clinical Significance for HIV Treatment
"ViiV Healthcare has led innovation in HIV (搜索) by developing effective regimens containing fewer medicines," said Jean van Wyk, Chief Medical Officer at ViiV Healthcare. "This 96-week PASO DOBLE sub-analysis adds to the robust clinical and real-world data for Dovato, showing differences between the 2-drug regimen DTG/3TC and BIC/FTC/TAF as a 3-drug regimen in metabolic health outcomes."
The findings provide important context for treatment selection, as steatotic liver disease (搜索) represents an increasingly recognized comorbidity linked to metabolic health and weight gain in people living with HIV (搜索), affecting 30% to 65% of patients. The condition is a leading cause of non-AIDS-related morbidity and mortality in this population.
Previous Study Data Supports Metabolic Benefits
Earlier 96-week results from the PASO DOBLE study had already demonstrated that switching to Dovato was associated with less weight gain than switching to Biktarvy, with a mean adjusted difference of 1.52 kg, while maintaining non-inferior virologic suppression between the two treatment arms. The current sub-study provides additional insight into the relationship between weight gain and liver steatosis outcomes when comparing these two regimens.
After adjusting for relevant baseline factors, treatment regimen remained independently associated with steatotic liver disease (搜索), suggesting the metabolic differences observed are directly related to the choice of HIV (搜索) therapy rather than other patient characteristics.
Market Impact and Future Outlook
Peak sales for Dovato are expected to reach $2.5 billion in 2027, according to GlobalData's patient-based forecast, with key patents set to expire between 2027 and 2031. The HIV (搜索) market across the seven major markets is forecast to grow at a compound annual growth rate of 1.9% from $26.5 billion in 2023 to $32.1 billion in 2033.
These metabolic health findings may influence treatment decisions as healthcare providers and patients increasingly consider long-term health outcomes beyond viral suppression when selecting HIV (搜索) therapies. The data supports the potential advantages of simplified two-drug regimens in managing HIV while minimizing metabolic complications.