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.[3]
Long-term data up to ~3 years[2]
A well-established safety profile[3]
*n=5 people excluded due to missing data or not completing follow-up.[18]
†55 people were included in the PP analysis.[10]
‡4 participants lost to follow-up. In total, 141 participants were included in the PP analysis.[11]
§77 people were included in the PP analysis.[13]
||Although DRAGON data at Week 96 is available, the effectiveness outcome of HIV-1 RNA <50 copies/mL has not been reported for Week 96 data.[16,20]
¶Although 252 people we included in the study, only 251 had available data at database lock.[15]
#Median time over which people naïve to treatment became suppressed was 10.4 weeks. Median time on treatment was 1.3 years.[8]
††162 people were included in the PP analysis.[9]
3DR, 3-drug regimen; 3TC, lamivudine; ART, antiretroviral therapy; BIC, bictegravir; DTG, dolutegravir; FDA, United States Food and Drug Administration; FTC, emtricitabine; ITT, intention-to-treat; ITT-E, intention-to-treat-exposed; M=F, missing=failure; PP, per-protocol; TAF, tenofovir alafenamide.
References:
- Figueroa M et al. Clin Infect Dis 2025. https://doi.org/10.1093/cid/ciaf415. [Epub ahead of print].
- Cahn P et al. AIDS 2022; 36(1): 39–48.
- DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC).
- Cordova E et al. Lancet HIV 2025; 12(2): e95–e104.
- Rolle C et al. Open Forum Infect Dis 2023; 10(3): ofad101.
- ViiV Healthcare. Data on File. REF-294793. 2025
- Schuettfort G et al. Poster presented at HIV Glasgow. 10–13 November 2024. Glasgow, UK. P057.
- Benson P et al. Infect Dis Ther 2024; 13(4): 875–889.
- Cabello-Ubeda A et al. J Acquir Immune Defic Syndr 2025. 100(2): e4–e7.
- Calza L et al. J Acquir Immune Defic Syndr 2025; 99(1): 93–97.
- Gan L et al. Expert Rev Anti Infect Ther 2024; 22(10): 877–884.
- Suárez-García I et al. J Antimicrob Chemother 2025; 80(3): 682–691.
- Hidalgo-Tenorio C et al. Viruses 2022; 14(3): 524.
- Hou H et al. Medicine 2024; 103(27): e38558.
- Allavena C et al. Poster presented at HIV Glasgow. 10–13 November 2024. Glasgow, UK. P059.
- Cheng C et al. Poster presented at AIDS 2024. 22–26 July. Munich, Germany. TUPEB111.
- Yang J et al. J Med Microbiol 2025; 74(1): 001949.
- Philibert P et al. Poster presented at HIV Drug Therapy Glasgow. 10–13 November 2024. Glasgow, UK. P082.
- Wei Y et al. Chin Med J 2023; 136(22): 2677–2685.
- Yang C et al. Poster presented at the International AIDS Society (IAS) Conference on HIV Science. 13–17 July 2025. Kigali, Rwanda. EP0146.
PM-GB-DLL-WCNT-250005 | February 2026
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.