Drug updated on 11/1/2024
| Dosage Form | Tablet (oral; dolutegravir [50 mg] and lamivudine: [300mg]) |
| Drug Class | Integrase strand transfer inhibitors [INSTI] and nucleoside analogue reverse transcriptase inhibitors [NRTI] |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a complete regimen for the treatment of HIV1 infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.
Latest News
Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- The studies primarily focused on ART (antiretroviral therapy)-naive people with HIV (PWH) and virologically suppressed PWH (people with HIV), demonstrating that dolutegravir/lamivudine maintained high rates of virologic suppression (97-100% at Week 48) with low rates of virologic failure (0-3.3 per 100 person-years), comparable to other regimens such as BIC/FTC/TAF and DTG/ABC/3TC at Week 144.
- Inflammatory biomarker assessments indicated significant changes favoring dolutegravir/lamivudine, particularly in studies like TANGO and SALSA, where soluble CD14 levels were positively impacted, highlighting the potential additional benefits of this regimen in managing inflammatory processes in virologically suppressed PWH.
- Studies included diverse age groups, primarily those aged ≥18 years, and real-world evidence showed that dolutegravir/lamivudine was effective across various populations, supporting its use in broader clinical settings.
- Serious Adverse Events: Dolutegravir/lamivudine was associated with fewer serious adverse events compared to BIC/FTC/TAF (OR 0.51; 95% CI 0.29-0.87; P = 0.014) and DTG/ABC/3TC (OR (odds ratio) 0.38; 95% CI (confidence interval) 0.19-0.75; P = 0.006) in the evaluated populations, which included both ART-naive and virologically suppressed people with HIV (PWH).
- Adverse Drug Reactions and Discontinuations: There were no significant differences in adverse drug reactions leading to treatment discontinuation between dolutegravir/lamivudine and triple-drug regimens (RR (relative risk) 1.74; 95% CI 0.73-4.17; P = 0.215), and real-world studies indicated low rates of discontinuation due to adverse events, consistent with trial data, with discontinuations reported in 13.6% (95% CI: 11.1-16.2) of patients at Week 48.
- Population Types and Subgroup Considerations: The studies included specific populations such as ART-naive people with HIV (PWH) and virologically suppressed PWH, with dolutegravir/lamivudine compared with other regimens in ART-naive PWH. High rates of virologic suppression (97-100% at Week 48) and low rates of virologic failure (0-3.3 per 100 person-years) for dolutegravir/lamivudine were reported, indicating its effectiveness across these groups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Dovato (dolutegravir and lamivudine) Prescribing Information. | 2024 | ViiV Healthcare, Durham, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Major revision version 12.0 of the European AIDS Clinical Society guidelines 2023. | 2023 | HIV Medicine |
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | National Institutes of Health |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | National Institutes of Health |
| European AIDS clinical society guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |