Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine) PD Tablet (oral; 60 mg of abacavir, 5 mg of dolutegravir, and 30 mg of lamivudine) |
| Drug Class | Integrase strand transfer inhibitors and nucleoside analogue reverse transcriptase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg.
Summary
- Abacavir, dolutegravir, and lamivudine (Triumeq) is indicated for the treatment of HIV-1 infection in adults and pediatric patients aged at least 3 months and weighing at least 6 kg.
- The information was derived from three randomized controlled trial studies that primarily compare Triumeq's effectiveness and safety with bictegravir co-formulated with emtricitabine and tenofovir alafenamide (B/F/TAF).
- All studies focused on adult populations; one highlighted treatment-naive adults, another addressed virologically suppressed adults. One study specifically excluded individuals who were HLA-B*5701 positive or had hepatitis B virus infection due to concerns about abacavir sensitivity affecting treatment choice.
- Both regimens demonstrated high efficacy in managing HIV-1 RNA levels to below detectable thresholds (<50 copies per mL). However, the bictegravir regimen was consistently found non-inferior to the dolutegravir regimen both for treatment-naive individuals as well as those switching from an established D/ABC/3TC regimen.
- In terms of safety across all studies reviewed, bictegravir exhibited a slightly better tolerability profile than dolutegravir. For instance, lower incidences of drug-related adverse events were reported in the bictegravir group compared to the dolutegravir group.
- The frequency of serious adverse events was comparable between groups but patient-reported outcomes suggest a potential edge in day-to-day tolerability for bictegravir over dolutegravir which could have significant implications for adherence and quality of life.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Triumeq (abacavir, dolutegravir, and lamivudine) prescribing Information. | 2023 | ViiV Healthcare Durham, NC |
Randomized Controlled Trials
Sex Distribution:
F:10%
M:90%
629Subjects
Year:
2019
Source:The Lancet HIV
Sex Distribution:
F:12%
M:88%
1192Subjects
Year:
2018
Source:The Patient-Patient-Centered Outcomes Research
Sex Distribution:
F:11%
M:89%
563Subjects
Year:
2018
Source:The Lancet HIV