TRIUMEQ PD (abacavir sulfate) · VIIV HLTHCARE
Triumeq PD is a fixed-dose combination of dolutegravir, abacavir, and lamivudine indicated for the treatment of HIV-1 infection in adults and pediatric patients who are at least three months old and weigh at least six kilograms. It is not recommended for individuals with suspected or confirmed resistance to integrase strand transfer inhibitors (INSTIs), as the dose of dolutegravir provided in this combination is insufficient for patients with resistance-associated substitutions.
How TRIUMEQ PD Works
Triumeq PD combines three antiretroviral agents from two different drug classes to inhibit HIV-1 replication: * **Dolutegravir** is an integrase strand transfer inhibitor (INSTI). It inhibits HIV integrase by binding to the active site and blocking the strand transfer step of retroviral DNA integration, which is essential for the HIV replication cycle. * **Abacavir and Lamivudine** are nucleoside reverse transcriptase inhibitors (NRTIs). Following intracellular phosphorylation to their active metabolites, they act as analogues of natural nucleosides. They compete for incorporation into viral DNA by the HIV reverse transcriptase enzyme, leading to DNA chain termination and inhibition of viral replication.
Details
- Status
- Prescription
- First Approved
- 2022-03-30
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
Companies
TRIUMEQ PD Approval History
What TRIUMEQ PD Treats
1 indicationsTRIUMEQ PD is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
TRIUMEQ PD 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 PD Competitive Set
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VIIV HLTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Trial Timeline
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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 PD FDA Label Details
Indications & Usage
FDA Label (PDF)TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir). TRIUMEQ and TRIUMEQ PD are a combination of dolutegravir (integrase...
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 PD Patents & Exclusivity
Patents (4 active)
Exclusivity
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Revenue Insights
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Patent Timeline
- • Cliff: 2030
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
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Competitive Landscape
- • 20 similar drugs
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Data Sources
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