Drug updated on 4/18/2024
| 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.
Summary
- Dolutegravir and lamivudine (Dovato) is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no history of antiretroviral treatment, or to replace the current antiretroviral regimen in those who are virologically suppressed.
- Four studies were conducted, each exploring different aspects of Dovato's role in treating HIV-1 infection, comparing it to other regimens in terms of safety, efficacy, and considerations for specific populations and subgroups.
- Compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and another dolutegravir-based regimen at 144 weeks, Dovato shows comparable efficacy with fewer serious adverse events, suggesting its long-term effectiveness and better safety profile.
- Evidence indicates high rates of virologic response from using Dovato, along with low discontinuation rates due to adverse events. This suggests that the regimen has a minimal impact on renal function and can improve lipid profiles and bone mineral density.
- A meta-analysis compared Dovato directly with traditional three-drug regimens over 48 weeks, showing similar efficacy and safety outcomes, which further confirms its competitive stance within the antiretroviral therapy landscape.
- Subgroup analysis shows that though primarily evaluated among patients naїve to antiretroviral therapy, Dovato is potentially effective even among individuals who have a history of virologic failure or high baseline viral loads, making it suitable for a broader range of clinical scenarios.
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 |