Dolutegravir Plus Lamivudine Comparable to 3-Drug Regimens for HIV-1
Dolutegravir plus lamivudine has no major dietary restrictions, and has potential for co-formulation into a single tablet.
In virologically suppressed individuals with HIV-1, dolutegravir plus lamivudine was noninferior to continuation of standard 3-drug maintenance therapy, according to a study published in Clinical Infectious Diseases.
Researchers in the pilot Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure study (ASPIRE; Clinicaltrials.gov identifier: NCT02263326) included adults with HIV-1 who were virologically suppressed on any 3-agent regimen for at least 48 weeks. The researchers randomly assigned participants to either continue their current 3-agent antiretroviral therapy or switch to open-label oral dolutegravir 50 mg plus lamivudine 300 mg once daily.
To determine the primary outcome, researchers compared the proportion of participants with treatment failure in the study group with the proportion of participants with treatment failure in the control group by week 24. They defined treatment failure as virologic failure, loss to follow-up, or treatment discontinuation or modification.
Of the 44 participants in the treatment group, 6.8% experienced treatment failure by week 24 compared with 6.7% of the 45 participants in the control group. Only 1 participant in the treatment group experienced virologic failure, and they did not experience any drug resistance.
"Adoption of two-agent maintenance therapy in routine practice would be enhanced by a regimen that combines efficacy, convenience, limited drug-drug interactions, long-term tolerability and safety," wrote the researchers.
Although the researchers note that their study is limited by its small sample size, they concluded that their results support the planned full clinical trial of this regimen.
Disclosures: To view a complete list of disclosures, please see the full text of the study. Drs Berzins and Nyaku report no conflicts of interest.
Taiwo BO, Marconi VC, Berzins B, et al. Dolutegravir plus lamivudine maintain HIV-1 suppression through week 48 in a pilot randomized trial [published online December 26, 2017]. Clin Infect Dis. doi: 10.1093/cid/cix1311/4775007.