Two-Drug HIV Regimen May Control Virus in Treatment-Naive Patients

ViiV Healthcare reported positive results from 2 phase 3 studies which were designed to evaluate the safety and efficacy of a 2-drug regimen of dolutegravir and lamivudine in comparison with a 3-drug regimen for treatment-naïve patients with HIV.

GEMINI 1 and GEMINI 2 are duplicate, phase 3 randomized, double-blind, multicenter, parallel group, non-inferiority studies. The GEMINI studies are part of ViiV Healthcare’s innovative clinical trial program for 2-drug regimens that seeks to reduce the number of medications used in HIV treatment in order to address long-term toxicity concerns.

The studies included approximately 1,400 participants that are treatment naïve HIV-1 infected adults with baseline viral loads less than 500,000 copies per ml. The studies were conducted at research centers in Europe, Central and South America, North America, South Africa, and the Asia Pacific.

During the course of the study, participants either received dolutegravir/lamivudine or dolutegravir and tenofovir disoproxil fumarate/emtricitabine. According to ViiV Healthcare, the studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per milliliter a standard measure of HIV control at week 48. According to the researchers, patients who experienced virologic failure did not develop treatment-emergent resistance.

“The GEMINI studies demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination. They affirm our two-drug regimen strategy and reinforce our belief that many patients can control their disease with two drugs instead of three or more. Importantly, the studies show that this two-drug regimen could be an option for treatment naïve patients and can support a broad range of patients living with HIV around the world,” said John C. Pottage, Jr, MD, chief scientific and medical officer of ViiV Healthcare in a statement.

Dolutegravir is an integrase strand transfer inhibitor (INSTI) designed to be used in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication through the process of preventing the viral DNA from integrating into the genetic material of T cells. This step is essential in the HIV replication cycle and is responsible for establishing chronic infection. Additionally, dolutegravir is approved in over 100 countries across North America, Europe, Asia, Australia, Africa, and Latin America. Lamivudine is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection.

ViiV Healthcare plans to apply for regulatory approval for the 2-drug regimen of dolutegravir and lamivudine later this year.