Drug updated on 9/4/2024
| 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
- 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.
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Summary
- Triumeq (abacavir, dolutegravir, and lamivudine) is 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.
- This summary is based on the review of one randomized controlled trial(s). [1]
- The proportion of participants achieving plasma HIV-1 RNA levels of less than 50 copies per mL at week 96 was 88% (276/314) in the bictegravir group and 90% (283/315) in the dolutegravir group, with a difference of -1.9% (95% CI: -6.9 to 3.1%), indicating non-inferiority between the two regimens.
- The study population consisted of adults aged ≥18 years, treatment-naive, HLA-B*5701 negative, without hepatitis B virus infection, and with an estimated glomerular filtration rate of at least 50 mL/min. No significant subgroup differences were reported in the study.
- Both bictegravir and dolutegravir regimens showed similar effectiveness in achieving the primary outcome, with no significant differences observed between the two groups.
- Common adverse events reported included nausea (11% in the bictegravir group vs. 24% in the dolutegravir group), diarrhea (15% in the bictegravir group vs. 16% in the dolutegravir group), and headache (13% in the bictegravir group vs. 16% in the dolutegravir group). Serious adverse events occurred in 11% of the bictegravir group and 12% of the dolutegravir group. No participants discontinued the bictegravir regimen due to adverse events, while 2% (5/315) discontinued the dolutegravir regimen due to adverse events.
- Study drug-related adverse events were reported in 28% of the bictegravir group and 40% of the dolutegravir group. There were two deaths in the bictegravir group (recreational drug overdose and suicide), which were not treatment-related. No deaths occurred in the dolutegravir group.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Triumeq (abacavir, dolutegravir, and lamivudine) Prescribing Information. | 2024 | ViiV Healthcare, Durham, NC |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. | 629Subjects F: 10% M: 90% | 2019 | The Lancet HIV |
Sex Distribution:
F:10%
M:90%
629Subjects
Year:
2019
Source:The Lancet HIV
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | National Institute of Health |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | National Institute of Health |
| European AIDS clinical society guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |