TRIUMEQ PD
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRIUMEQ PD (TRIUMEQ PD).
Triumeq PD is a combination of abacavir (a nucleoside reverse transcriptase inhibitor, NRTI) and dolutegravir (an integrase strand transfer inhibitor, INSTI). Abacavir is phosphorylated to carbovir triphosphate, which inhibits HIV-1 reverse transcriptase by competing with natural dGTP and causing DNA chain termination. Dolutegravir inhibits HIV-1 integrase by binding to the integrase active site and blocking strand transfer, preventing integration of viral DNA into host DNA.
| Metabolism | Abacavir is primarily metabolized by alcohol dehydrogenase and glucuronyl transferase (UGT2B7) to inactive glucuronide and carboxylate metabolites. Dolutegravir is metabolized primarily by UGT1A1 with minor contribution from CYP3A4. |
| Excretion | Abacavir: 83% renal (unchanged and metabolites via alcohol dehydrogenase and glucuronidation), 16% fecal. Dolutegravir: 64% fecal (unchanged), 32% renal (unchanged and glucuronide conjugate). Lamivudine: 70% renal (unchanged). |
| Half-life | Abacavir: 1.5-2.0 hours. Dolutegravir: 14 hours (single dose), 11-13 hours (steady state). Lamivudine: 13-19 hours. Clinical context: Dolutegravir half-life supports once-daily dosing; abacavir rapid elimination requires twice-daily dosing. |
| Protein binding | Abacavir: ~50% (no specific protein). Dolutegravir: ~99% (albumin and alpha-1 acid glycoprotein). Lamivudine: <36% (no specific protein). |
| Volume of Distribution | Abacavir: 0.86 L/kg (distributes into tissues including brain). Dolutegravir: 17.4 L (limited; distributes into CSF and genital tract). Lamivudine: 1.3 L/kg (high distribution into total body water). |
| Bioavailability | Abacavir: 83% (oral). Dolutegravir: Not determined as solution; tablet bioavailability not given but absorption is 100% (absolute) after oral administration. Lamivudine: 86-88% (oral). |
| Onset of Action | Oral: For abacavir, peak plasma concentration within 1-1.5 hours; for dolutegravir, within 2-3 hours; for lamivudine, within 0.5-2 hours. Clinical antiviral effect detectable within days, maximal viral suppression by 4-8 weeks. |
| Duration of Action | Dolutegravir: 24 hours (once-daily dosing). Abacavir and lamivudine: 12 hours (twice-daily dosing). Clinical notes: Adherence to dosing schedule critical; missed doses may lead to suboptimal concentrations and virologic failure. |
One tablet (abacavir 600 mg / dolutegravir 50 mg / lamivudine 300 mg) orally once daily.
| Dosage form | TABLET, FOR SUSPENSION |
| Renal impairment | Contraindicated if CrCl <30 mL/min. No dose adjustment required for CrCl >=30 mL/min. |
| Liver impairment | Contraindicated in Child-Pugh class C. No dose adjustment for mild to moderate (Child-Pugh A or B) impairment, but use with caution. |
| Pediatric use | For children weighing >=40 kg: one tablet (abacavir 600 mg / dolutegravir 50 mg / lamivudine 300 mg) orally once daily. For children <40 kg, use individual components. Safety and efficacy not established for children <12 years or <40 kg. |
| Geriatric use | No specific dose adjustment required, but monitor renal function due to age-related decline in CrCl; avoid if CrCl <30 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRIUMEQ PD (TRIUMEQ PD).
| Breastfeeding | Breastfeeding not recommended due to potential for HIV transmission and adverse effects. Dolutegravir transfers into breast milk with infant plasma concentrations approximately 3% of maternal (M/P ratio ~1.1). Lamivudine and abacavir also excreted in breast milk. |
| Teratogenic Risk | First trimester: Exposure to dolutegravir is associated with an increased risk of neural tube defects (NTDs), with prevalence approximately 0.9 per 1000 pregnancies (vs 0.1 per 1000 without exposure). Second and third trimesters: No increased risk of major malformations, but possible risk of preterm birth and low birth weight. Lamivudine and abacavir have no known teratogenic risk. |
■ FDA Black Box Warning
Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir. Patients who carry the HLA-B*5701 allele are at higher risk. Discontinue promptly if hypersensitivity is suspected, regardless of HLA-B*5701 status. Contraindicated in patients with HLA-B*5701 positivity.
| Serious Effects |
["Presence of HLA-B*5701 allele (contraindication for abacavir)","Moderate or severe hepatic impairment (Child-Pugh class B or C)","Previous hypersensitivity reaction to abacavir","Concomitant use with dofetilide (dolutegravir contraindication due to increased dofetilide levels and risk of arrhythmia)"]
| Precautions | ["Hypersensitivity reactions (abacavir): screen for HLA-B*5701 before initiation; do not rechallenge after a hypersensitivity reaction","Lactic acidosis and severe hepatomegaly with steatosis (NRTI class effect)","Hepatic adverse events in patients with hepatitis B or C co-infection","Fat redistribution and immune reconstitution syndrome","Drug interactions (e.g., with polyvalent cations, metformin, and certain anticonvulsants)","Risk of neural tube defects with dolutegravir at the time of conception; avoid use in women of childbearing potential unless alternative options are not available"] |
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| Fetal Monitoring | Baseline and periodic liver function tests, renal function, blood glucose, and complete blood count. Monitor for hypersensitivity reactions (especially with abacavir, HLA-B*5701 testing required before initiation). In pregnancy, close fetal monitoring with ultrasound for NTDs if exposed in first trimester; consider folate supplementation. Viral load monitoring every 4-6 weeks and at delivery. |
| Fertility Effects | No evidence of impaired fertility in men or women based on preclinical and clinical data. Dolutegravir, lamivudine, and abacavir do not adversely affect spermatogenesis or oogenesis. |