ViiV's Dovato Shows Lower Steatotic Liver Disease Rates Compared to Biktarvy in HIV Patients

Patients who switched to Dovato had significantly lower rates of steatotic liver disease, especially those with clinically meaningful weight gain.

Feb. 24, 2026 at 11:12am

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In a Phase IV study, 29% of HIV patients who switched to ViiV Healthcare's two-drug regimen Dovato experienced steatotic liver disease, compared to 49% of those who switched to Gilead's three-drug regimen Biktarvy. The difference was most pronounced in patients with clinically meaningful weight gain of 5% or more, where steatotic liver disease was reported in 76% of Biktarvy patients but only 17% of Dovato patients.

Why it matters

Steatotic liver disease is an increasingly common comorbidity linked to metabolic health issues in people living with HIV, affecting 30-65% of patients and leading to significant non-AIDS-related morbidity and mortality. These findings suggest Dovato may offer metabolic health benefits compared to Biktarvy, which could have important implications for long-term patient outcomes.

The details

The data was presented from the Phase IV PASO DOBLE study (NCT04884139), which enrolled adults living with HIV who were virologically suppressed and switched to either Dovato or Biktarvy. After 96 weeks of treatment, the difference in steatotic liver disease rates was most pronounced in those with clinically meaningful weight gain of 5% or more - 76% in the Biktarvy group compared to 17% in the Dovato group. No significant difference was seen in those who gained less than 5% of their baseline body weight.

  • The data was presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.
  • The PASO DOBLE study enrolled patients and followed them for 96 weeks.

The players

ViiV Healthcare

A pharmaceutical company that specializes in HIV treatments and is a joint venture between GlaxoSmithKline, Pfizer, and Shionogi.

Dovato

A two-drug HIV regimen containing the integrase inhibitor dolutegravir and the nucleoside reverse transcriptase inhibitor lamivudine, developed by ViiV Healthcare.

Biktarvy

A three-drug HIV regimen containing the integrase inhibitor bictegravir, the nucleoside reverse transcriptase inhibitor emtricitabine, and the nucleotide reverse transcriptase inhibitor tenofovir alafenamide, developed by Gilead Sciences.

Jean van Wyk

Chief medical officer at ViiV Healthcare.

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What they’re saying

“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.”

— Jean van Wyk, Chief medical officer at ViiV Healthcare

What’s next

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 takeaway

These findings suggest that the two-drug regimen Dovato may offer metabolic health benefits compared to the three-drug regimen Biktarvy, which could have important implications for the long-term care and outcomes of people living with HIV.