Janssen Submits NDA for Once-Daily, Single-Tablet Regimen to Treat HIV

Today, September 25, 2017, Janssen Research & Development, LLC announced that they have submitted a new drug application (NDA) for a darunavir-based, once-daily, single-tablet regimen for the treatment of HIV in adults and adolescents who are 12 years of age or older.

“If approved, [darunavir 800 mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide/ 10mg] D/C/F/TAF will be the only complete regimen to deliver the potential adherence advantages of a single tablet regimen (STR) with the high genetic barrier to resistance of darunavir and demonstrated safety profile of TAF,” according to the press release.

In a recent interview with Contagion^® at the 9th IAS Conference on HIV Science, Magda Opsomer, MD, director, clinical leader, Infectious Diseases and Vaccines, from Janssen Pharmaceutical Companies, in Belgium, explains why darunavir may be more beneficial compared with other available HIV medications.

It was due to the favorable results yielded from two phase 3 studies—EMERALD and AMBER—that Janssen made the decision to submit the NDA to the US Food and Drug Administration. For the 48-week EMERALD study, investigators sought to assess how safe and effective switching to the D/C/F/TAF instead of staying on “a boosted protease inhibitor (PI) plus F/TDF regimen.” For the AMBER study, also a 48-week study, investigators assessed if the D/C/F/TAF regimen was safer and more effective in treatment-naïve patients than a DRV/C+F/TDF regimen was.

Janssen reports that both phase 3 trials have found “high rates of virologic suppression and no treatment-emergent DRV or TAF resistance among both treatment-naïve adult patients and virologically suppressed adult patients who switched regimens.”

Representatives from Janssen will report the data from both studies at upcoming infectious disease conferences. Dr. Opsomer provided a brief overview of the results yielded by the EMERALD study; the data will also be presented at ID Week which will be held next week in San Diego, California, from October 4-8, 2017. The data yielded from the AMBER study will be shared at the European AIDS Conference occurring later in the month, October 25-27, 2017, in Milan, Italy.

According to the US Department of Health and Human Services, adhering to HIV treatment regimens can be very difficult for individuals for several reasons, including the following:

• Side effects from interactions between HIV drugs and other medications the individual may be taking
• A busy schedule, including traveling for work, may make it hard to take medications on time
• Unstable living or housing situations
• Illness or depression
• Alcohol or drug use
• Fear of associated stigma
• Lack of health insurance to cover cost of HIV drugs

However, due to the fact that this new treatment regimen would only be a once-daily, single-pill treatment, it might make it a little bit easier for individuals to remember to take it correctly.

“This filing marks an important milestone in continuing to address the needs of individuals living with HIV who struggle with adherence and the associated risks of developing medication resistance,” Richard Nettles, vice president, Medical Affairs at Janssen, stressed in the press release. He added, “If approved, this treatment will enable us to expand our promising portfolio of products for those living with HIV to include a medicine that for the first time brings together darunavir’s high genetic barrier to resistance with the safety profile if tenofovir alafenamide, in a once daily, single-pill dosing regimen.”

Janssen teamed up with Gilead Sciences, Inc. in amending a licensing agreement for “the development and commercialization of a once-daily STR combination” regimen, consisting of darunavir and Gilead’s TAF, emitricitabine, and cobicistat back in December 2014, according to the press release. For more information on the EMERALD and AMBER trials, go to www.clinicaltrials.gov.