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DTG
DTG (dolutegravir) is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA.
DTG (dolutegravir) is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults, HIV-1 infection in adolescents and children.
At a glance
| Generic name | DTG |
|---|---|
| Also known as | Tivicay®, 3TC, TDF, Dolutegravir |
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Dolutegravir binds to the catalytic site of HIV integrase and inhibits the strand transfer step of viral integration into the host genome. This prevents establishment of productive HIV infection and reduces viral replication. It is a second-generation integrase inhibitor with improved potency and a higher genetic barrier to resistance compared to first-generation agents.
Approved indications
- HIV-1 infection in treatment-naïve adults
- HIV-1 infection in treatment-experienced adults
- HIV-1 infection in adolescents and children
Common side effects
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers (PHASE2)
- Shortened Regimen for Drug-susceptible TB in Children (PHASE3)
- 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)
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:
- DTG CI brief — competitive landscape report
- DTG updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI