A switch to the two-drug HIV regimen Dovato (dolutegravir/lamivudine) was associated with a lower proportion of steatotic liver disease (SLD) compared to the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in adults living with HIV-1 who are virologically suppressed, according to 96-week data presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado. The findings, announced February 23, 2026, by ViiV Healthcare, build on earlier metabolic findings and offer further insight into the potential benefits of simplified HIV treatment regimens.
Steatotic liver disease, increasingly recognized as a common health issue among people living with HIV, was reported in 49% (26 of 53 participants) of those who switched to Biktarvy, versus 29% (17 of 58 participants) who switched to Dovato, according to a sub-group analysis of the PASO DOBLE (GeSIDA 11720) study. This suggests that the two-drug regimen may offer a metabolic advantage for certain patients. The study is the largest head-to-head, phase IV randomized clinical trial investigating Dovato compared with Biktarvy in virologically suppressed adults.
Understanding Steatotic Liver Disease and HIV
SLD, also known as fatty liver disease, is a condition where excess fat builds up in the liver. It’s often linked to metabolic health issues like obesity, diabetes and high cholesterol. In people living with HIV, the risk of developing SLD is elevated, potentially due to factors like chronic inflammation, antiretroviral therapy, and changes in body composition. The increasing prevalence of SLD in this population highlights the necessitate for treatment strategies that minimize metabolic complications.
PASO DOBLE Study Details and Findings
The PASO DOBLE study, a randomized clinical trial, compared the efficacy and safety of Dovato and Biktarvy in adults with HIV who had a suppressed viral load. The 96-week sub-analysis focused specifically on the incidence of SLD. Researchers found a statistically significant difference in the proportion of participants developing SLD between the two treatment groups. The data presented at CROI 2026 reinforces earlier findings suggesting a potential metabolic benefit with Dovato.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, stated, “ViiV Healthcare has led innovation in HIV by developing effective regimens containing fewer medicines.” The company emphasized that these findings add to the growing body of clinical and real-world data supporting Dovato’s use in maintaining viral suppression while potentially improving metabolic health. ViiV Healthcare’s press release details the study findings.
Implications for HIV Treatment
The findings from the PASO DOBLE study could influence treatment decisions for individuals with HIV. Dovato, a two-drug regimen, offers a simplified treatment option compared to the traditional three-drug regimens like Biktarvy. For patients who are virologically suppressed and have concerns about metabolic health, the potential for a lower risk of SLD with Dovato may be a significant consideration. However, it’s crucial to note that treatment decisions should be made in consultation with a healthcare provider, taking into account individual patient factors and medical history.
What is Dovato and Biktarvy?
Dovato combines dolutegravir and lamivudine, two antiretroviral medications that work by inhibiting the HIV virus from replicating. Biktarvy, is a three-drug combination containing bictegravir, emtricitabine, and tenofovir alafenamide. Both regimens are highly effective at suppressing HIV, but they differ in their composition and potential metabolic effects. Yahoo News reports on the study’s implications for HIV patients.
Looking Ahead
ViiV Healthcare continues to investigate the long-term effects of Dovato and its impact on various health parameters in people living with HIV. Further research is needed to fully understand the mechanisms underlying the observed differences in SLD rates between Dovato, and Biktarvy. The company plans to continue monitoring data from the PASO DOBLE study and other clinical trials to refine treatment guidelines and optimize patient care. The next planned data release from the PASO DOBLE study is expected in the first quarter of 2027.
This research provides valuable information for healthcare providers and individuals living with HIV, highlighting the importance of considering metabolic health when selecting an antiretroviral regimen. If you have questions about your HIV treatment options, please consult with your doctor.
Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your treatment plan.
What are your thoughts on this new research? Share your comments below, and please share this article with anyone who might find it helpful.
