GlaxoSmithKline (GSK Quick QuoteGSK - Free Report) announced that its HIV-focused company, ViiV Healthcare has initiated a phase III program to support regulatory filings for a two-drug regimen of Tivicay and Epivir for the treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy.

ViiV Healthcare was formed in Nov 2009 by Glaxo and Pfizer, Inc. (PFE Quick QuotePFE - Free Report) . The partners were later joined by Shionogi in Oct 2012.

We note that the GEMINI trials comprise the third development program undertaken by ViiV Healthcare to investigate a two-drug regimen for the treatment of HIV. The phase III program includes two identical studies – GEMINI 1 and GEMINI 2. The two studies are designed to compare Tivicay plus Epivir with a three-drug regimen of Tivicay plus the fixed-dose tablet Truvada. Each study will enroll approximately 700 subjects who will be randomized 1:1 to receive Tivicay plus Epivir or Tivicay plus Truvada.

The primary efficacy endpoint will be measured at week 48 and the study will continue to evaluate long-term antiviral activity, tolerability and safety of Tivicay plus Epivir through week 148.

HIV currently has no cure. With the phase III GEMINI program, ViiV Healthcare intends to evaluate if this two-drug regimen can fundamentally change the existing HIV treatment strategy, thereby reducing the number of medications and potentially streamlining treatment regimens for people suffering from the disease.

Both Glaxo and Pfizer currently carry Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Actelion Ltd and Corcept Therapeutics (CORT Quick QuoteCORT - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).

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