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Once-daily ABC+3TC
ABC+3TC is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors (NRTIs) that blocks HIV reverse transcriptase to prevent viral replication.
ABC+3TC is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors (NRTIs) that blocks HIV reverse transcriptase to prevent viral replication. Used for HIV-1 infection (as part of combination antiretroviral therapy).
At a glance
| Generic name | Once-daily ABC+3TC |
|---|---|
| Also known as | ABC: abacavir: Ziagen, 3TC: lamivudine: Epivir, ABC+3TC co-formulated: Kivexa |
| Sponsor | Medical Research Council |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) combination |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Abacavir (ABC) and lamivudine (3TC) are both NRTIs that inhibit HIV reverse transcriptase by competing with natural nucleosides and causing chain termination during viral DNA synthesis. The once-daily formulation combines these two agents to improve adherence while maintaining suppression of HIV replication. This combination is a backbone component of antiretroviral therapy regimens.
Approved indications
- HIV-1 infection (as part of combination antiretroviral therapy)
Common side effects
- Hypersensitivity reaction (abacavir)
- Headache
- Nausea
- Diarrhea
- Fatigue
- Lactic acidosis (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 Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS) (PHASE1, PHASE2)
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Study of GS-1219 in Participants With HIV-1 (PHASE1)
- Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive (PHASE4)
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:
- Once-daily ABC+3TC CI brief — competitive landscape report
- Once-daily ABC+3TC updates RSS · CI watch RSS
- Medical Research Council portfolio CI