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Two Drug HIV Regimen Has Fewer Side Effects


A two-drug regimen for those just starting treatment has moved closer to FDA approval.

A new HIV regimen option could replace existing three-drug regimens with a two-drug one, for those just beginning treatment. The yet-unnamed drug would join Juluca as another two-drug regimen capable of replacing three-drug versions. Juluca was recently approved by the U.S. Food and Drug Administration for adults already on treatment and virally suppressed.

Although a three-drug regimen was once considered essential in order to prevent the development of resistance, new two-drug regimens are proving to be just as effective without some of the side effects of the previous multidrug options. HIV treatment is already moving to single-tablet regimens, breaking the tedium of endlessly taking a handful of pills. But even in a single pill, stomaching three or more drugs daily can come with unwanted side effects and inevitably puts a toll on the body over long periods of time.

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

Toxicity in antiretroviral drugs is an important factor to consider, especially as poz people age. Organizations like the World Health Organization monitor drug therapies and the toxicity associated with them. Reducing the amount of medications that people living with HIV are consigned to take improves adherence and long-term health outcomes, while reducing potential toxicities.

These are reasons why pharma companies are looking for two-drug combinations that can do the work previously done by three.

ViiV Healthcare reported that in Phase 3 studies, the dolutegravir and lamivudine combination demonstrated the ability to control HIV in people who hadn’t previously taken antiretroviral medications. The two supportive studies, dubbed GEMINI-1 and GEMINI-2, were designed to assess the safety profile and efficacy of dolutegravir (an integrase inhibitor) and lamivudine (a nucleoside reverse transcriptase inhibitor) compared to a three-drug regimen of dolutegravir combined with two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate and emtricitabine.

The studies were conducted at research centers throughout Europe, Central and South America, North America, South Africa, and Asia Pacific; and involved 1,400 men and women living with HIV. While details are still forthcoming (more will be revealed at an upcoming conference), researchers showed that the two-drug regimen was effective, with participants reaching viral suppression (with viral loads less than 50 copies per milliliter) by week 48.

None of the participants (even those whose viral loads weren’t controlled) developed treatment-emergent resistance, or drug resistance that develops after a person begins taking medication. Drug resistance is always a concern when it comes to antiretrovirals, because of HIV’s ability to mutate frequently and adapt to the drugs meant to combat it.

“The GEMINI studies demonstrate the potency, safety, and tolerability of the dolutegravir plus lamivudine combination,” Pottage said. “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 naive patients and can support a broad range of patients living with HIV around the world.”

ViiV Healthcare is planning to submit the two-drug regimen of dolutegravir and lamivudine to the FDA for approval later this year.

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Benjamin M. Adams