FDA just approved Juluca, a drug that might be the answer to treating HIV and AIDS!
The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes HIV infection and over time acquired immunodeficiency syndrome (AIDS). AIDS is a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. Without treatment, average survival time after infection with HIV is estimated to be 9 to 11 years, depending on the HIV subtype.
The new FDA approved drug – Juluca
Two large studies have found that the two-drug combination of Tivicay (dolutegravir) and Edurant (rilpivirine) works as well as standard three- or four-antiretroviral (ARV) regimens.
At the beginning of the clinical trial in February this year, the participants were taking a standard ARV regimen and had an undetectable viral load.
They either remained on their original regimen or switched to ViiV Healthcare’s integrase inhibitor Tivicay plus Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant.
First and foremost, the researchers looked at the rates of those with an undetectable viral load after 48 weeks of treatment.
These rates were comparable between the two treatment groups. Given the apparent success of the trials, nine months later, for the first time, the U.S. Food and Drug Administration (FDA) has approved an HIV treatment regimen that contains only two antiretrovirals (ARVs), instead of the standard three or more drugs.
Juluca (dolutegravir/rilpivirine), a combination of drugs from ViiV Healthcare and Janssen, is approved as a new option for people with HIV who have been virally suppressed on their current ARV regimen for at least six months.
The FDA approval is based on two identical clinical trials, SWORD 1 and 2, which included 1,024 people with HIV who were initially on successful ARV treatment. Findings from these studies were reported in February at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
The participants were randomized to stay on their current regimen or switch to the components of Juluca. Those who took the two-drug regimen had the same rate of viral suppression after 48 weeks (95 percent) as those who stayed on their initial regimen.
The most common adverse health events among those taking Juluca were diarrhea and headache, each reported by 2 percent of the participants.
Fewer drugs in an HIV treatment regimen should spell less toxicity, at least in theory. Future research should indicate whether the two-drug regimen does indeed confer a long-term safety advantage over regimens including three or more ARVs, in particular with regard to bone and kidney health.