Phase 3 Program Launched for HIV Treatment Regimen

ViiV Healthcare, an HIV company established by GlaxoSmithKline and Pfizer, recently announced plans to launch a phase 3 program to evaluate a new HIV treatment.

The 2-drug regimen of dolutegravir (Tivicay) and lamivudine (Epivir) treats patients with HIV-1, who have not received prior antiretroviral treatment. The phase 3 program consists of the studies GEMINI 1 and 2, whicch compares the 2-drug regimen of dolutegravir plus lamivudine with a 3-drug regimen of dolutegravir plus a fixed-dose tablet of tenofovir/emtricitabine (Truvada), according to a press release from GlaxoSmithKline.

Both randomized, double-blind studies will compare the safety, efficacy, and tolerability of the 2 treatment regimens. There will be approximately 700 patients included in each study, and will be randomized 1:1 for each treatment. GEMINI 1 and 2 are designed to show non-inferior antiviral activity of the dolutegravir plus lamivudine regimen, compared with dolutegravir plus the tenofovir/emitrivitabine fixed-dose combination.

The primary efficacy endpoint will be evaluated at week 48, but the study will continue to evaluate the long-term effects on antiviral activity, tolerability, and safety of the 2-drug combination. These 2 studies are the third development program from ViiV Healthcare analyzing a 2-drug regimen for HIV treatment.

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor used with other antiretroviral treatments, and has been approved in more than 100 countries, according to the press release. Known adverse reactions include insomnia, fatigue, and headache.

However, the treatment may also effect serum liver biochemistries in patients with hepatitis B or C virus, and may cause immune reconstitution syndrome. Lamivudine (Epivir) is a nucleoside analogue used with other antiretroviral agents.

Known adverse reactions include headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough. It also comes with a boxed warning regarding lactic acidosis and severe hepatomegaly, exacerbations of hepatitis B virus, and different formulations of the drug, according to the press release.

“We believe the clinical profile for dolutegravir presents an important opportunity to investigate the possibility of first-line treatment of HIV with a 2-drug regimen,” said John C Pottage, Jr, MD, chief scientific and medical officer, ViiV Healthcare. “With this ambitious phase III program, we will explore whether this 2-drug regimen can fundamentally change the existing HIV treatment strategy, reducing the number of medications and potentially streamlining treatment regimens for people living with HIV.”