Two-Drug Antiretroviral HIV Treatment Performs Well in Recent Trials

The advancement of drugs to prevent and treat HIV in recent years are helping to reduce the rate of new infections and help those living with HIV live longer and healthier lives. Now to add to the progress, a recent announcement from drug maker GlaxoSmithKline details positive results from two trials of new antiretroviral therapy (ART) drug regimens.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) in 2014 announced its Fast-Track initiative, a plan to end the AIDS epidemic by 2030. While such a goal may seem ambitious, health officials believe the target is within reach thanks to technological advances and scientific breakthroughs. The World Health Organization (WHO) attributes the reduction of HIV infections and related deaths to ART drugs, which suppress the HIV virus from multiplying and stop the progression of disease. WHO recommends that those infected with HIV begin a regimen of these drugs as early as possible after diagnosis to reduce the risk of developing life-threatening infections, and endorses ART therapy as a pre-exposure prophylaxis for those at substantial risk of HIV infection.

ART treatment regimens involve taking a combination of drugs on a daily basis to keep viral loads low and infections at bay. By taking these drug “cocktails” regularly, individuals with HIV can keep their immune systems that are strong enough to fight infections and cancers, while also reducing their risk of passing on the virus to others. The cocktails are often made up of a combination of three or more ART drugs from six classes of HIV medicines. With the right mix of drugs in the right dosages short-term side effects such an anemia, fatigue, and nausea can be minimal. Long-term side effects, such as insulin resistance and bone density loss, can make it hard for some patients to adhere to their treatment plans.

In a recent news release from GlaxoSmithKline, the drug maker announced positive results from two recent Phase III studies testing the safety and efficacy of a two-drug antiretroviral regimen for HIV. The combination under investigation included dolutegravir and rilpivirine taken in concert by virologically suppressed patients who had been taking a cocktail of three or four HIV medications. At the end of the trial, the two-drug regimen met the primary endpoint of non-inferiority to the multiple drug regimens. This was determined based on the number of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48.

GlaxoSmithKline, which developed the two-drug cocktail through ViiV Healthcare, of which they have majority ownership, shared the news of the successful trials while noting that they will release detailed findings of these trials at an upcoming scientific meeting. “These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated,” said Dominique Limet, CEO of ViiV Healthcare, in a recent statement. “The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”