Last reviewed 2026-05-31 · How we verify

Dolutegravir (DTG)

Dolutegravir (DTG) is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by ViiV Healthcare. It is currently FDA-approved for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults, HIV-1 infection in adolescents and children (weight-based dosing). Also known as: Tivicay.

Dolutegravir inhibits HIV integrase, preventing the virus from inserting its genetic material into the host cell's DNA.

Dolutegravir (DTG) is a small molecule used to treat HIV, HIV-1, and HIV-1 infection. It is often combined with other medications, such as lamivudine, for treatment.

At a glance

Mechanism of action

Dolutegravir is an integrase strand transfer inhibitor (INSTI) that binds to the catalytic site of HIV integrase and blocks the enzyme's ability to catalyze the integration of viral DNA into the human genome. By preventing this critical step in the HIV replication cycle, the drug stops viral propagation and reduces viral load in infected individuals. It is highly potent and has a high genetic barrier to resistance.

Approved indications

• HIV-1 infection in treatment-naïve adults
• HIV-1 infection in treatment-experienced adults
• HIV-1 infection in adolescents and children (weight-based dosing)

Common side effects

• Insomnia
• Headache
• Diarrhea
• Nausea
• Fatigue
• Hypersensitivity reaction

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.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Dolutegravir (DTG) CI brief — competitive landscape report
• Dolutegravir (DTG) updates RSS · CI watch RSS
• ViiV Healthcare portfolio CI

Frequently asked questions about Dolutegravir (DTG)

Related

• Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
• Target: All drugs targeting HIV integrase
• Manufacturer: ViiV Healthcare — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for HIV-1 infection in treatment-naïve adults
• Indication: Drugs for HIV-1 infection in treatment-experienced adults
• Indication: Drugs for HIV-1 infection in adolescents and children (weight-based dosing)
• Also known as: Tivicay

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing