The U.S. Food and Drug Administration has approved a new HIV drug specifically for poz folks who are switching HIV meds. ViiV Healthcare’s Juluca is the first two-drug regimen approved that combines dolutegravir and rilpivirine, and the first not to include a nucleoside reverse transcriptase inhibitor (NRTI).
Juluca is only approved for those who are already in treatment and undetectable, but are currently seeking to switch medications. According to ViiV, it is indicated as a complete regimen for maintenance treatment of HIV-1 (the most common strain) in adults who have suppressed viral loads (less than 50 copies per mL), and have been on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known resistance to the individual components.
Financial analysts from data analytics company Global Data are already projecting sales of Juluca could exceed $2 billion by 2025, due to the fact that it’s the first HIV regimen of its kind. Current antiretroviral therapy regimens contain at least three drugs to reduce the development of drug resistance. All previously approved regimens have relied on a backbone of two NRTIs, but those drugs have been associated with what Global Data calls an “increased risk of adverse events associated with cumulative ART exposure, particularly renal- and bone-related issues.”
Juluca instead relies on the integrase strand transfer inhibitor dolutegravir and the non-nucleoside reverse transcriptase inhibitor rilpivirine (from Janssen Therapeutics). This makes the drug useful not only for those who may have developed resistance to NRTIs like Truvada, but additionally for anyone who also has liver- or bone-related medical issues.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, M.D., director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, told End Points News.
The FDA approval was based on data from two phase III clinical trials, which revealed that the two-drug regimen achieved viral suppression as well as three- or four-drug regimens, and that adverse side-effects occurred infrequently.
An unrelated 2016 study in Spain suggested there are many benefits to a two-drug combination, including the discovery that it might reduce the risk of cardiovascular disease and kidney problems linked to toxicities associated with the use of two NRTIs.
Deborah Waterhouse, CEO of ViiV Healthcare, said in a written statement, “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. 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 U.S., to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”
As Waterhouse suggests, expanding options for HIV treatments is particularly important because the increased longevity of people living with HIV means that poz people (starting with long-term survivors) must take medications for decades to remain virally suppressed. That can increase the likelihood of developing drug resistance or toxicities to the medications, which are both reasons to switch.