Two-Drug Regimen Proves To be Effective in Controlling HIV

A new and improved two-drug HIV regimen option could replace an existing three-drug regimen, and the data suggests that it can adequately control HIV. The unnamed new drug would join the FDA-approved Juluca as another two-drug regimen replacing an older three-drug regimen. Juluca was approved and is used to treat certain adults who are virologically suppressed. The new ViiV drug is a two-drug regimen specifically for people who beginning treatment treatment for the first time.

Stomaching three drugs daily — and many more drugs in some cases —  eventually becomes tedious and inevitably puts a toll on the body, which is why some current developments in HIV medicine are focusing on reducing the amount of medications that people living with HIV are consigned to take.

ViiV Healthcare reported landmark results in phase III studies for dolutegravir and lamivudine, which demonstrated the ability to control HIV in patients who haven’t taken medication for HIV, according to a June 13 press release.

The two supportive studies, dubbed GEMINI-1 and GEMINI-2, were designed to assess the safety profile and efficacy of dolutegravir and lamivudine compared to a three-drug regimen of dolutegravir combined with two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine.

The studies met their goal by reaching a standard measure of HIV control, with less than 50 copies per milliliter in plasma samples. This goal was achieved at week 48 of their studies. None of the patients who didn’t gain control of their viral load in either treatment arm developed treatment-emergent resistance, or resistance that begins only after therapy with the drugs. Drug resistance is usually an important concern when it come to antiretrovirals, because of HIV’s nature and its ability to mutate and adapt to any changes.

Drug makers and the scientists behind the GEMINI studies hope to help improve the quality of life for people living with HIV. “People with HIV are living longer and more productive lives,” John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said. “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 naive patients and can support a broad range of patients living with HIV around the world.”

The study was expansive. Some 1,400 men and women living with HIV were observed and studies were conducted at research centers throughout Europe, Central and South America, North America, South Africa and Asia Pacific.

Taking three or more drugs daily isn’t going to be the case in the near future, with new offerings currently in development.

Toxicity in antiretroviral drugs is an important thing to consider, especially as people living with HIV age. Organizations like the World Health Organization keep a closely vigilant eye on drug therapies and the toxicity associated with them. By reducing the amount of chemicals and drugs that people living with HIV have to take can help reduce the amount of potentially toxic ingredients they ingest.

ViiV Healthcare is planning its regulatory submissions for the two-drug regimen of dolutegravir and lamivudine later this year, according to the press release.