DOVATO is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.[1]
Why DOVATO? Weight counselling Weight impact Bone and renal impact
Fewer clinically significant DDIs with non-ARVs vs. other single-tablet regimens including BIC/FTC/TAF, as reported in EACS 2025 guidelines†,[2]
May provide a neutral impact on bone biomarkers, and low renal impact[3]
Why consider the impact of weight as part of your treatment decisions?[5]
To support the future health of your patients, BHIVA guidelines recommend that the impact of weight gain should be considered when selecting ART.[5]
The adjusted mean weight gain was 64% lower for DOVATO vs. BIC/FTC/TAF at Week 96 in treatment-experienced participants*,[6]
PASO DOBLE is the largest head-to-head, randomised controlled trial of DOVATO vs. BIC/FTC/TAF in treatment-experienced participants.[6] Week 96 data continued to widen the difference seen at Week 48.[6]
Weight change from baseline through Week 96[6]
Adapted from Masia M et al. 2025.[6]
Proportion of participants with weight gain >5% through 96 weeks[6]
Adapted from Masia M et al. 2025.[6]
5% gain in body weight was ~3.6 kg for the average participant.[4]
Overall, participants included in PASO DOBLE presented a median baseline weight of 72.8 kg across both arms.[4]
Primary endpoint: the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at 48 weeks in the ITT-E population (FDA Snapshot, 4% non-inferiority margin)[4]
Key secondary endpoints: the change in weight and the proportion of participants with >5% weight change at 96 weeks (the study was powered to assess differences in weight change)[4]
A similar trend of lower weight gain vs. BIC/FTC/TAF was shown in a naïve to treatment retrospective real-world cohort[13]
Weight gain data in people naïve to treatment is mixed in regard to the impact of specific antiretrovirals. Further confirmatory studies are needed.
Primary endpoint: proportion of participants who experienced ≥10% increase in weight through 96 weeks‡,[13]
Adapted from Yang C et al. 2025.[13]
10% gain in body weight was ~6.5 kg for the average participant.[13]
DOVATO may provide a neutral impact on bone biomarkers and low renal impact[3]
Small changes in renal function and bone biomarkers were observed from baseline up to ~3 years, which favoured DOVATO vs. DTG + TDF/FTC§,[3]
Adverse effects due to renal and urinary disorders with DOVATO (n=2/716) were infrequent and comparable to DTG + TDF/FTC (n=12/717)[3]
* This analysis was adjusted by sex, presence of TAF in previous regimen, age and race.[6]
†As defined in EACS guidelines. Includes the most common and clinically relevant interactions with 43 non-ARV medications, which are commonly co-prescribed with HIV therapy. Original data source: University of Liverpool HIV drug interaction data.[2] EACS guidelines state that no additional DDIs are expected when 3TC is added to other ARTs including DTG.[1,2]
‡The primary endpoint was the proportion of participants who experienced a ≥10% increase in weight at Week 96.[13] For the DOVATO and BIC/FTC/TAF groups at baseline, respectively, CD4+ T-cell counts were 301 (189–426) and 240 (93–390) cells/µL (p=0.01), and HIV-1 RNA levels were 4.75 (4.14–5.32) and 5.03 (4.38–5.68) log10 copies/mL (p<0.01).[13] To balance for differences in baseline characteristics between the DOVATO and the BIC/FTC/TAF groups, a propensity model using inverse probability of treatment weighting was generated.[15]
§Bone and renal biomarkers include GFR from cystatin C, CKD-EPI (mL/min per 1.73 m2), creatinine (µmol/L), GFR from creatinine adjusted for BSA (mL/min per 1.73 m2), protein/creatinine (g/mol), retinol binding protein/creatinine (µg/mmol), beta-2 microglubulin/creatinine (mg/mmol), and bone-specific alkaline phosphatase, osteocalcin, procollagen 1 N-terminal propeptide, and type 1 collagen C-telopeptide.[3]
AIDS, acquired immunodeficiency syndrome; ART, antiretroviral therapy; ARV, antiretroviral; BIC, bictegravir; BSA, body surface area; CI, confidence interval; CKD-EPI, chronic kidney disease epidemiology collaboration; DDI, drug-drug interaction; DTG, dolutegravir; EACS, European AIDS Clinical Society; FDA, United States Food and Drug Administration; FTC, emtricitabine; GFR, glomerular filtration rate; IAS, International AIDS Society; ITT-E, intention-to-treat-exposed; OR, odds ratio; SE, standard error; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
References:
- DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC)
- European AIDS Clinical Society (EACS) Guidelines. Version 13.0. October 2025.
- Cahn P et al. AIDS 2022; 36(1): 39–48.
- Ryan P et al. Lancet HIV 2025; 12(7): e473-e484
- BHIVA guidelines on antiretroviral treatment for adults living with HIV-1 2022 (2025 interim update).
- Masia M et al. Abstract presented at the European AIDS Conference (EACS). 15–18 October 2025. Paris, France. 1515.
- Schneider S et al. Infect Dis Ther. 2024; 13(4): 891–906.
- Silva Sombra I et al. Braz J Infect Dis 2021; 25(Suppl 1): 101045.
- Calza L et al. J Antimicrob Chemother 2020; 75(11): 3327–3333.
- Tan M et al. HIV Med 2019; 20(9): 634–637.
- Yagci Caglayik D et al. Poster presented at the European AIDS Conference (EACS). 25–27 October 2017. Milan, Italy. PE912.
- Kumar S and Samaras K. Front Endocrinol (Lausanne) 2018; 9: 705.
- Yang C et al. Poster presented at the International AIDS Society (IAS) Conference on HIV Science. 13–17 July 2025. Kigali, Rwanda. EP0146.
- Figueroa M et al. Clin Infect Dis 2025. https://doi.org/10.1093/cid/ciaf415. [Epub ahead of print].
- Yang C et al. 2025. doi:10.20944/preprints202501.0297.v1. [Epub ahead of print].
PM-GB-DLL-WCNT-250007 | February 2026
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