Juluca (dolutegravir and rilpivirine), the first two-drug regimen for certain patients with HIV is now available in pharmacies across the United States. In November 2017, Viiv Healthcare, owned by pharmaceutical giant GlaxoSmithKline, gained US Food and Drug Administration (FDA) approval for maintenance treatment of HIV-1 infections in adults who are: virologically suppressed, on a stable antiretroviral regimen for at least six months, and with no treatment failure or substitutions due to resistance to dolutegravir or rilpivirine.

Data from the Centers for Disease Control and Prevention (CDC) suggests HIV infection rates are on the decline, with the number of new infections in the country falling by ten percent between 2010 and 2014. However, CDC figures also show more than 1 million people in the United States still live with HIV infection, including more than 160,000 who have yet to have their condition diagnosed.

At the time of Juluca’s approval, CEO of Viiv Healthcare Deborah Waterhouse described the FDA’s decision as “the start of a new era in HIV treatment.” The drug is a once-daily single pill treatment designed to provide suitable patients with a way to reduce the number of antiretrovirals taken without compromising on the efficacy of a more traditional three-drug treatment program. 

Juluca is a combination of two medications: integrase strand transfer inhibitor dolutegravir, and the non-nucleoside reverse transcriptase inhibitor rilpivirine. Pills contain 50mg of dolutegravir and 25mg of rilpivirine. Approval from the FDA was granted following two phase III clinical trials which demonstrated the two-drug regimen was comparable in efficacy after 48 weeks to results in trials using three or four drugs.  

Common Side Effects and Adverse Reactions to Juluca

The most common adverse reactions to Juluca were headaches and diarrhea. Other more serious side effects include skin rashes, allergic reactions, liver injury, organ dysfunction, depression, and changes in mood. 

It is contraindicated in patients with hypersensitivity to either dolutegravir or rilpivirine. It is also contraindicated for coadministration with dofetilide and with any drug where “significant decreases in rilpivirine plasma concentrations may occur”. The drug is also not recommended for breastfeeding mothers. 

For more information on Juluca, visit https://juluca.com