Dolutegravir/Lamivudine for HIV Non-Inferior to 3-Drug Regimen

ViiV Healthcare’s 2-drug HIV regimen of dolutegravir (Tivicay, 50 mg) plus lamivudine (Epivir, 300 mg) demonstrated non-inferiority compared with a regimen containing tenofovir alafenamide fumarate (TAF), according to data from a phase 3 study.

The phase 3 TANGO trial assessed the antiviral efficacy and safety of switching to the 2-drug combination in adults with HIV who are virally suppressed and stable on a TAF-containing regimen.

For the study, eligible participants had been on a TAF-containing regimen with HIV-1 RNA <50 copies per milliliter (c/mL) for at least 6 months, without prior virologic failure, no historical nucleoside reverse transcriptase or integrase inhibitor major resistance mutation, and no evidence of hepatitis B infection. Participants were randomized to switch to dolutegravir plus lamivudine or continue on the TAF-containing regimen through week 148.

Overall, top-line results demonstrated that the study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 c/mL at week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. Additionally, safety results for the 2-drug regimen were consistent with the product labeling for each medicine.

“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression,” Kimberly Smith, MD, head of global research and medical strategy at ViiV Healthcare, said in a statement. “These week 48 data clearly indicate that they can—individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.”

Currently, the single-pill, 2-drug regimen of dolutegravir plus lamivudine is approved in the United States for the treatment of HIV in adults with no antiretroviral treatment history and with no known resistance to either medicines.

The full results from the study will be presented at the 10^th International AIDS Society Conference on HIV Science.

Reference

ViiV Healthcare announces phase 3 study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen [news release]. GlaxoSmithKline. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-phase-iii-study-meets-primary-endpoint/. Accessed July 17, 2019.