Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; dolutegravir [50 mg] and lamivudine: [300mg]) |
| Drug Class | Integrase strand transfer inhibitors and nucleoside analogue reverse transcriptase inhibitors |
| 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
- Dovato (dolutegravir and lamivudine) is indicated as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 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.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Virologic Suppression and Failure: At Week 144, DTG+3TC demonstrated similar virologic suppression (HIV-1 RNA < 50 copies/mL) and virologic failure (HIV-1 RNA ≥ 50 copies/mL) rates compared to BIC/FTC/TAF and DTG/ABC/3TC. Real-world studies reported high virologic suppression rates (97-100% at Week 48) and low virologic failure rates (0-3.3 per 100 person-years) for DTG+3TC.
- Safety Profile: DTG+3TC had fewer serious adverse events compared to BIC/FTC/TAF and DTG/ABC/3TC (OR, 0.51 and 0.38, respectively) and similar overall adverse events and discontinuation rates. Minimal impact on renal function, lipid profiles, and bone mineral density was noted.
- Population-Specific Outcomes: In ART-naive people with HIV-1 (PWH), DTG+3TC showed comparable efficacy and safety to other regimens. In virologically suppressed PWH, including those with a history of virologic failure, DTG+3TC maintained high suppression rates and low failure rates. In patients with baseline viral load >100,000 RNA copies/ml, DTG+3TC was as effective as other regimens.
- DTG+3TC had minimal impact on renal function, lipid profiles, and bone mineral density, with safety outcomes broadly similar to other regimens over 48 weeks.
- The reviewed evidence includes data from ART-naive people with HIV-1, virologically suppressed PWH with a history of virologic failure, and patients with a baseline viral load >100,000 RNA copies/ml, showing that DTG+3TC is effective and safe across these specific subgroups, with high virologic suppression rates and low virologic failure, even in those with high baseline viral loads or a history of virologic failure.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Dovato (dolutegravir and lamivudine) Prescribing Information. | 2023 | ViiV Healthcare., Durham, NC |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor-based, 3-drug, single-tablet regimens in therapy-naive people with HIV-1. | 2023 | AIDS Research and Therapy |
| Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature. | 2023 | Expert Review of Anti-Infective Therapy |
| HIV treatment with the two-drug regimen dolutegravir plus lamivudine in real-world clinical practice: a systematic literature review. | 2021 | Infectious Diseases and Therapy |
| Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. | 2019 | Acquired Immune Deficiency Syndrome |