Patients with HIV showed lower cases of steatotic liver disease when switched to ViiV Healthcare’s Dovato compared to Biktarvy.
In the Phase IV PASO DOBLE study (NCT04884139), 29% of patients who started Dovato (dolutegravir/lamivudine (DTG/3TC)) experienced steatotic liver disease compared with 49% in the Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) cohort after 96 weeks of treatment.
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Patients enrolled in the trial were adults living with HIV who were virologically suppressed and who switched to either Dovato or Gilead’s Biktarvy.
The difference was most pronounced in those with clinically meaningful weight gain of ≥5% of baseline body weight, where steatotic liver disease was reported in 76% of patients who received Biktarvy and 17% of those who received Dovato. No significant change was seen in those who gained <5% of their baseline body weight.
Chief medical officer at ViiV Healthcare, Jean van Wyk, said: “ViiV Healthcare has led innovation in HIV by developing effective regimens containing fewer medicines. This 96-week PASO DOBLE sub-analysis adds to the robust clinical and real-world data for Dovato, showing differences between the two-drug regimen DTG/3TC and BIC/FTC/TAF as a three-drug regimen in metabolic health outcomes.”
Results were presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.
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By GlobalDataSteatotic liver disease is an increasingly recognised comorbidity linked to metabolic health and weight gain in people living with HIV, affecting 30% to 65% of patients. It is a leading cause of non-AIDS-related morbidity and mortality.
Peak sales for Dovato are expected to reach $2.5bn in 2027, according to GlobalData’s patient-based forecast, with key patents set to expire between 2027 and 2031.
Beyond the treatment space, there have been significant developments in the HIV prevention sector, with Gilead’s twice-yearly pre-exposure prophylaxis (PrEP) Yeztugo (lenacapavir) branded as a “game changer” for HIV, having prevented 100% and 99% of HIV cases in two Phase III trials.
The HIV market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is forecast to grow at a compound annual growth rate (CAGR) of 1.9% from $26.5bn in 2023 to $32.1bn in 2033, forecasts GlobalData.
GlobalData is the parent company of Clinical Trials Arena.
