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. |
| Molecular Weight | Dolutegravir: 419.4 Da; Abacavir: 286.3 Da; Lamivudine: 229.3 Da. Overall, 286-419 Da range. |
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 | Avoid unless benefit outweighs risk. Dolutegravir has been associated with neural tube defects when used at conception; data for abacavir and lamivudine are more reassuring but limited. |
| 2nd trimester | May be used if alternative regimens are not available. Monitor for hepatic toxicity and mitochondrial toxicity. |
| 3rd trimester | May be used if alternative regimens are not available. Monitor for neonatal anemia and neutropenia due to lamivudine. |
Clinical note
Comprehensive clinical and safety monograph for TRIUMEQ PD (TRIUMEQ PD).
| Placental transfer | All three components (abacavir, lamivudine, dolutegravir) cross the placenta. Dolutegravir achieves cord blood concentrations similar to maternal plasma; abacavir and lamivudine demonstrate moderate transfer. |
| Breastfeeding | Breastfeeding is not recommended in settings where formula is available and safe, as antiretrovirals may be excreted in breast milk and potential for HIV transmission exists. If used, monitor infant for adverse effects such as anemia and neutropenia. |
■ 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 |
Hypersensitivity to any component (abacavir, lamivudine, dolutegravir)HLA-B*5701 positive patients (abacavir hypersensitivity risk)Severe hepatic impairment (Child-Pugh Class C)
| 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 |
| Food/Dietary |
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| Lactation Rating | L4 - Possibly Hazardous |
| 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. |
| 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. |
| No significant food interactions. TRIUMEQ PD can be taken with or without food. Avoid taking with magnesium/aluminum-containing antacids, calcium or iron supplements, or sucralfate as they may reduce absorption; separate by at least 2 hours (iron/calcium) or 6 hours (antacids). |
| Clinical Pearls | TRIUMEQ PD (abacavir/dolutegravir/lamivudine) is a fixed-dose combination tablet for pediatric HIV treatment. Prior to initiation, screen for HLA-B*5701 allele; if positive, abacavir is contraindicated due to high risk of hypersensitivity reaction. Dolutegravir may be associated with neural tube defects if taken during early pregnancy; confirm pregnancy status in females of childbearing potential. Monitor renal function as lamivudine and dolutegravir are renally excreted; dose adjustment needed for CrCl <50 mL/min. Advise patients to report any symptoms of hypersensitivity (fever, rash, GI symptoms, malaise) immediately. |
| Patient Advice | Take this medication exactly as prescribed, with or without food, at the same time each day. · Do not miss doses; if a dose is missed within 4 hours of the usual time, take it as soon as possible; otherwise skip the missed dose. · Contact your doctor immediately if you develop fever, rash, nausea, vomiting, diarrhea, abdominal pain, extreme tiredness, or achiness, as these may be signs of a serious allergic reaction (hypersensitivity reaction). · This medication does not cure HIV or prevent transmission; use effective barrier protection (condoms) during sexual activity. · If you are a female of childbearing potential, discuss pregnancy plans and contraceptive methods with your doctor; this drug can cause harm to an unborn baby. · Store at room temperature (20-25°C) in the original container, away from moisture and light. |