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Dolutegravir/Lamivudine
Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block HIV replication.
Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block HIV replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based formulations).
At a glance
| Generic name | Dolutegravir/Lamivudine |
|---|---|
| Also known as | Dovato |
| Sponsor | Saint Michael's Medical Center |
| Drug class | Antiretroviral combination (INSTI + NRTI) |
| Target | HIV integrase; HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
This is a fixed-dose combination of two antiretroviral agents. Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks the enzyme responsible for inserting viral DNA into human chromosomes. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that terminates viral DNA chain elongation. Together, they provide complementary mechanisms to suppress HIV replication.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection in adolescents and children (weight-based formulations)
Common side effects
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
- Hypersensitivity reaction (rare)
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa (NA)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- Study of GS-3242 in Participants With HIV-1; Substudy-05 (PHASE1)
- DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dolutegravir/Lamivudine CI brief — competitive landscape report
- Dolutegravir/Lamivudine updates RSS · CI watch RSS
- Saint Michael's Medical Center portfolio CI