TRIUMEQ (abacavir sulfate)
TRIUMEQ is indicated for the treatment of HIV-1 Infection.
How TRIUMEQ Works
This medication combines three HIV-1 antiretroviral agents: dolutegravir, abacavir, and lamivudine. Dolutegravir functions as an integrase strand transfer inhibitor (INSTI), while abacavir and lamivudine are nucleoside analogue reverse transcriptase inhibitors (NRTIs). These components work in combination to target and inhibit the viral enzymes required for the replication of HIV-1.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-08-22
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TRIUMEQ Approval History
What TRIUMEQ Treats
1 indicationsTRIUMEQ is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
TRIUMEQ Boxed Warning
HYPERSENSITIVITY REACTIONS, AND EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine). Patients who carry the HLA ‑ B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir, although hypersensitivity reactions have occurred in patients who do not carry the HLA ‑ B*5701 allele [se...
WARNING: HYPERSENSITIVITY REACTIONS, AND EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine). Patients who carry the HLA ‑ B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir, although hypersensitivity reactions have occurred in patients who do not carry the HLA ‑ B*5701 allele [see Warnings and Precautions ( 5.1 )] . TRIUMEQ and TRIUMEQ PD are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA ‑ B*5701-positive patients [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . All patients should be screened for the HLA ‑ B*5701 allele prior to initiating therapy with TRIUMEQ or TRIUMEQ PD or reinitiation of therapy with TRIUMEQ or TRIUMEQ PD, unless patients have a previously documented HLA ‑ B*5701 allele assessment. Discontinue TRIUMEQ or TRIUMEQ PD immediately if a hypersensitivity reaction is suspected, regardless of HLA ‑ B*5701 status and even when other diagnoses are possible [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . Following a hypersensitivity reaction to TRIUMEQ or TRIUMEQ PD, NEVER restart TRIUMEQ or TRIUMEQ PD or any other abacavir ‑ containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions ( 5.1 )] . Exacerbations of Hepatitis B All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating TRIUMEQ or TRIUMEQ PD. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If TRIUMEQ or TRIUMEQ PD is used in patien
TRIUMEQ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TRIUMEQ
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04827134 results posted | 216149 | Ph 1 | completed | A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants |
| NCT02924389 results posted | IRB00089025 K23AI124913 | Ph 4 | terminated | Dolutegravir in Reservoirs |
| NCT02569346 SCRUM | UMCN-AKF 15.02 | Ph 1 | completed | Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet |
| NCT02868580 Lighthouse | CUR-101 | Ph 2 | completed | Safety and Tolerability of Antiretroviral (Triumeq) in Patients With Amyotrophic Lateral Sclerosis (ALS). |
| NCT02509195 | SSAT064 2014-004970-40 | Ph 4 | completed | SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over |
| NCT02556268 | 17957 | Ph 1 | completed | Interaction With HIV Antiretroviral Agents |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRIUMEQ FDA Label Details
Indications & Usage
FDA Label (PDF)TRIUMEQ is indicated for the treatment of HIV-1 Infection.
WARNING: HYPERSENSITIVITY REACTIONS, AND EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine). Patie...
TRIUMEQ Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TRIUMEQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 4 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment