On Mar19, 1987, the U.S. FDA approved the first antiretroviral drug, zidovudine(AZT) for HIV-AIDS. In the intervening years, antiretroviral therapy(ART) has grown to encompass more than 25 drugs across 6 drug classes with a combined market value of $22 billion. .Antiretroviral therapy has helped numerous patients live longer, healthier lives while reducing the risk of transmission.
In most patients, the treatment begins with three drugs from 2 of the 6 different drug classes. For most patients, to achieve undetectable viral loads in their blood, they must strictly adherence to the regime indefinitely.
Despite careful consideration by doctors, many ART patients suffer adverse effects as a result of these toxic drugs including renal failure, neuromuscular weakness, and necrosis. This frequently leads to discontinuation of treatment or death. Monthly HIV treatment can cost patients anywhere from $2000-$5000 a month due to the expensive 4 pill drug regimen and is a major financial burden.
This month, two different companies are seeking to essentially change the game with a move towards a 2 drug treatment strategy. This new treatment methodology could potentially reduce adverse side effects as well as decrease the financial burden associated with the usage of 4 different drugs. GSK and ViiV Healthcare, specializing in HIV drugs submitted regulatory approvals for a single-tablet, two drug regimen of dolutegravir(Tivicay, Viiv Healthcare) and ripilvirine(Edurant, Janssen Sciences Ireland UC) to FDA and EMA. ViiV Healthcare is majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders.
Going head to head with GSK, is the U.S. drugmaker Gilead which has evaluated the addition of bictegravir(Gilead) to emtricitabine/tenofovir alafenamide(FTC/TAF) currently in use to treat HIV. On May 30, Gilead announced that this three-drug regimen was equally good or “non-inferior” to combinations using dolutegravir as found in four late-stage studies. Gilead will submit regulatory approvals this year.
Gilead was one of the key players in the HIV drugs market until the approval of dolutegravir(GSK) in 2013. In the past few years, dolutegravir has been a star player for GSK and Viiv Healthcare. With this 2 drug regimen racing towards approval, GSK seems tipped to grab a greater share of the HIV drugs market. However, keynotes from Gilead regarding its new regimen show that kidney function was unaffected, a key side effect of current ART therapy including dolutegravir. This could be an important consideration for healthcare practitioners.