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Dolutegravir/abacavir/lamivudine FDC
This fixed-dose combination inhibits HIV integrase and reverse transcriptase to prevent viral replication and reduce viral load in HIV-infected patients.
This fixed-dose combination inhibits HIV integrase and reverse transcriptase to prevent viral replication and reduce viral load in HIV-infected patients. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age and weight-dependent formulations).
At a glance
| Generic name | Dolutegravir/abacavir/lamivudine FDC |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Antiretroviral combination (INSTI + NRTIs) |
| Target | HIV integrase, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing integration of viral DNA into the host genome. Abacavir and lamivudine are nucleoside reverse transcriptase inhibitors (NRTIs) that inhibit reverse transcriptase, blocking conversion of viral RNA to DNA. Together, these three agents target multiple steps of the HIV replication cycle.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection in adolescents and children (age and weight-dependent formulations)
Common side effects
- Diarrhea
- Nausea
- Headache
- Insomnia
- Hypersensitivity reaction (abacavir)
- Hepatotoxicity
- Lactic acidosis
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA) (PHASE3)
- A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants (PHASE1)
- Effects of Biktarvy on CFR in Stable HIV Patients (PHASE3)
- ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection (PHASE3)
- Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection (NA)
- Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (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/abacavir/lamivudine FDC CI brief — competitive landscape report
- Dolutegravir/abacavir/lamivudine FDC updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI