The US Food and Drug Administration (FDA) has approved the first once-daily, two-drug single pill treatment for certain patients with human immunodeficiency virus type 1 (HIV-1). Approval for Juluca (dolutegravir and rilpivirine) was granted to ViiV Healthcare, a global specialist in HIV owned by pharmaceutical giant GlaxoSmithKline.
Juluca contains 50mg of the integrase strand transfer inhibitor dolutegravir and 25mg of rilpivirine, a non-nucleoside reverse transcriptase inhibitor. It is a complete treatment for patients with HIV-1 who have been virologically suppressed for at least six months, with no history of treatment failure and no substitutions associated with resistance to rilpivirine or dolutegravir.
The drug was approved following two clinical trials of 1,024 people whose virus was suppressed by their current anti-HIV medication. These showed Juluca was effective in viral suppression and the results demonstrated its efficacy was comparable to that of existing anti-HIV medicine.
A variety of drug classes are currently used to treat HIV and minimize the likelihood of spreading infection, including nucleoside reverse transcriptase inhibitors (NRTIs) such as Ziagen (abacavir), and protease inhibitors, such as Reyataz (atazanavir). A number of combination therapies are also available, such as Descovy (emtricitabine, tenofovir alafenamide) and Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide).
Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, commented: “Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients.”.
Centers for Disease Control and Prevention (CDC) estimates suggest more than 1 million people in the United States live with HIV. In 2014, the United States released health guidelines highlighting the benefits of early treatment for patients with HIV, noting this reduces levels of HIV in the body, decreasing the likelihood of transmission to others. Around 15 percent of Americans living with HIV are unaware of their HIV-positive status, according to the CDC’s latest Morbidity and Mortality Weekly Report.
Common Side Effects of Juluca:
The most common side effects seen in patients taking Juluca were diarrhea and headaches. Other serious side effects included skin rashes, allergic reactions, liver problems, depression, and mood chances.
The drug should not be prescribed alongside other anti-HIV medication as there is a risk of interactions with these and other commonly used medication.
