GSK’s Duo-Combo HIV Treatment Gives Positive Trial Results

ViiV Healthcare, established in November 2009 by GlaxoSmithKline, Pfizer Inc. and Shiongi, reported positive results from its Phase III GEMINI-1 and -2 clinical trials for its two-drug regimen for HIV.

The two studies were evaluating the safety and efficacy of its two-drug regimen (2DR) of dolutegravir and lamivudine compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment naive HIV-1 adults with baseline viral loads less than 500,000 copies per milliliter (mL). The trials met their primary endpoint, which was non-inferiority based on plasma HIV-1 RNA <50 copies per mL, which is a standard HIV control measure. They were evaluated at Week 48.

The combo’s safety profile was consistent with product labeling for the individual drugs. The two studies are part of ViiV’s program to evaluate two-drug regimen’s long-term toxicity concerns. They involve about 1,400 men and women with HIV and are being conducted in Europe, Central and South America, North America, South Africa and Asia Pacific.

ViiV plans to submit the combination to regulators later this year.

“People with HIV are living longer and more productive lives,” said John Pottage, ViiV Healthcare’s chief scientific and medical officer, in a statement. “However, under current standard of care, many patients still take three or more medicines every day. 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.”

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI). It is designed to be used in combination with other antiretroviral drugs. It has been approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America. In May, U.S. and European regulatory authorities were evaluating evidence that this drug might be linked to serious birth defects. However, the European Medicines Agency (EMA) panel in March recommended the two-drug combo be approved. It was approved by the U.S. Food and Drug Administration (FDA) in November 2017.

Lamivudine is a nucleoside analogue. It is also used in combination with other antiretroviral drugs. It is sold under the brand name Epivir as well as in generic versions.

In May, ViiV and GSK announced the European Commission had granted marketing authorization for Juluca (dolutegravir 50mg/rilpivirine 25mg) to treat HIV-1 in virologically suppressed adults on a stable antiretroviral regimen for at least six months with no history of virological failure or resistance to any non-nucleoside reverse transcriptase inhibitor or integrate inhibitor. Dolutegravir is a ViiV product, while rilpivirine is a Johnson & Johnson/Janssen product.

Juluca was approved in the U.S. on November 21, 2017 as a complete regiment to treat HIV-1 infection in adults for the same specifics as in Europe.