FDA approves new two-drug, single tablet Juluca for people with well controlled HIV

On November 21, 2017, the Food and Drug Administration approved a new two-drug, combination pill to treat HIV infection in people whose viral loads are already well controlled on another regimen. The once-a-day medication, called Juluca, is a combination of the integrase inhibitor dolutegravir (Tivicay) and the NNRTI rilpivirine (Edurant). Both individual drugs and the new combo pill are manufactured by ViiV Healthcare.

HIV regimens usually include three drugs to fully control HIV infection — by suppressing the virus in two steps of its life cycle. This is true for people who are starting treatment for the first time or for those who switch to another regimen over time. However, this new regimen uses only two drugs to do the same thing — but only after the virus has already been controlled by another regimen.

The approval of Juluca is based upon the results from two clinical studies (SWORD-1 and SWORD-2) of 1,024 people. All participants had HIV that was fully suppressed at the start with 3- or 4-drug regimens. Half continued on their regimens while the other half switched to the new two-drug regimen. The studies compared whether a “maintenance” regimen of dolutegravir + rilpivirine suppressed HIV as well as a standard regimen. The results showed that it did — with a 95% suppression rate in both groups.

The only drawback is that not everyone will be able to switch over to the new regimen. Those who are eligible to take Juluca are those who have controlled HIV for at least 6 months, have had no history of failed treatment, and currently have no resistance mutations that are associated with dolutegravir and rilpivirine.

“This new regimen will help some people living with HIV reduce the number of drugs they take over time,” stated Project Inform’s Director of Education Alan McCord. “Since HIV treatment is currently taken for life, taking fewer drugs can help reduce the risk of potential long-term side effects, and thereby improving quality of life.”

Juluca must be taken with a meal. Side effects seen in the two clinical studies included inflammation of the nose and throat, headache, upper respiratory tract infections and diarrhea.

For a detailed analysis of the results from SWORD-1 and -2, go to aidsmap.com.