UK-based pharmaceutical company ViiV Healthcare has initiated its Phase III programme to support the regulatory filings of a two-drug regimen of dolutegravir (Tivicay) and lamivudine (Epivir) to treat HIV-1 infection in adults.
Dolutegravir (Tivicay) is developed as an integrase strand transfer inhibitor (INSTI) to be used in combination with other anti-retroviral agents indicated to treat HIV.
The replication of HIV is blocked by the integrase inhibitors by preventing the viral DNA from adhering into the genetic material of human immune cells (T-cells).
Lamivudine is a nucleoside analogue used in combination with other anti-retroviral agents to treat HIV infection. It is available in branded (Epivir) and other generic forms.
ViiV’s Phase III programme is comprised of two identical studies, GEMINI I and II.
Both the studies are randomised, double-blind trials designed to evaluate the safety, efficacy, and tolerability of a two-drug regimen of dolutegravir and lamivudine against dolutegravir and two nucleoside reverse transcriptase inhibitors administered on a once-daily basis.
The studies are expected to enrol about 700 HIV patients each who have not received any prior anti-retroviral therapy.
The patients will be randomised on a 1:1 basis to be administered with dolutegravir and lamivudine or dolutegravir and tenofovir / emtricitabine fixed-dose combination.
The studies are primarily focused to measure the efficacy of dolutegravir and lamivudine, which will be tested after completing 48 weeks of the study and thereafter continue determining its anti-viral activity, tolerability and safety through Week 148.
ViiV healthcare chief scientific and medical officer John Pottage said: “We believe the clinical profile for dolutegravir presents an important opportunity to investigate the possibility of first-line treatment of HIV with a two-drug regimen.
“With this ambitious phase III programme, we will explore whether this two-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.”
ViiV is conducting the Gemini trials as its third development programme aimed at treating HIV.