First Two-Drug HIV Regimen Approved by FDA

Janssen Therapeutics’ Juluca has become the first single-pill, two-drug regimen to treat patients with human immunodeficiency virus type 1 (HIV-1) infection. While currently-available HIV treatments combine three or more drugs – increasing the risk of side effects – Juluca combines two previously-approved drugs, dolutegravir and rilpivirine.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Dr. Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

Patients may be eligible to switch to Juluca if they have been stable on an antiretroviral regimen for six months or more, and are virologically supressed. Individuals must also have no history of treatment failure and must not be resistant to either of the compounds in Juluca.

“Today’s approval of Juluca marks a significant milestone in the treatment of HIV,” said Brian Woodfall, Global Head of Late Development, Janssen Research & Development. “This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider.”

It’s estimated that 1.1 million individuals in the US are living with a chronic HIV infection, according to the Centers for Disease Control and Prevention (CDC). While global HIV mortality decreased by 22 percent between 3009 and 2013 – due to improved access to treatment – the chronic infection can never be cured, representing a significant unmet need for patients.

Juluca is the result of a collaboration between Johnson & Johnson’s subsidiary, Janssen and ViiV Healthcare, which was established in 2014. ViiV is owned by GlaxoSmithKline, Pfizer and Shionogi. Janssen markets rilpivirine alone under the name Edurant, while dolutegravir is owned by ViiV and branded as Tivicay.

The FDA approval was based on the results from two Phase III clinical trials, which included more than 1,000 patients with HIV-1. After 48 weeks of treatment with the two-drug antiretroviral therapy (ART), the investigators found that Juluca was non-inferior to a three-drug therapy in terms of viral suppression.

“The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care,” said Deborah Waterhouse, CEO ViiV Healthcare. “This is the start of a new era in HIV treatment. We are delighted to be able to provide the first two-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”

According to ViiV, the company has other drugs in its two-drug HIV regimen pipeline, including one combination therapy for treatment-naïve patients, and another for naïve and treatment-experienced individuals. Both investigational HIV therapies are currently in Phase III development.