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Gilead files NDA for once-daily HIV treatment
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Gilead Sciences is seeking FDA approval for its investigational, once-daily regimen of emtricitabine 200 mg and tenofovir alafenamide 25 mg, plus Janssen Pharmaceutical’s rilpivirine 25 mg, for the treatment of HIV-1 infection in adult and pediatric patients aged 12 years and older, according to the press release.
The FDA is expected rule on the new drug application (NDA) for the combination treatment (R/F/TAF) within 6 months of accepting it.
The drugmaker suggests tenofovir alafenamide (TAF) — a novel nucleotide reverse transcriptase inhibitor (NRTI) — may provide greater antiviral efficacy at a dose less than one-tenth that of its other HIV-1 treatment, Viread (tenofovir disoproxil fumarate; TDF). TAF also has demonstrated improved renal and bone laboratory parameters compared with TDF, according to the release.
“R/F/TAF is Gilead’s third TAF-based filing in less than a year, and we are looking forward to the potential to offer people living with HIV another effective treatment option with a favorable safety profile,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in a press release. “The R/F/TAF filing also represents Gilead’s next collaboration with Janssen in our combined efforts to increase and potentially improve HIV treatments for a range of patients.”
Gilead’s application supports the use of R/F/TAF for treatment-naive patients and virologically suppressed patients seeking a new ART option.
In addition to R/F/TAF, Gilead has filed NDAs for a single-tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF), given once daily, as well as a two-dose combination of emtricitabine (200 mg/10 mg) and TAF (200 mg/25 mg) to be used with other antiretrovirals, according to the release. The FDA is expected to rule on these filings in November and April 2016, respectively.
The NDA for R/F/TAF is based on a bioequivalence study that showed the treatment achieved the same drug levels of emtricitabine and TAF in the blood as E/C/F/TAF (TAF 10 mg), and the same drug levels of rilpivirine as a 25-mg dose of rilpivirine administered alone. According to Gilead, TAF has shown to be safe and effective for a range of HIV patients in a number of clinical studies — including treatment-naive adults and adolescents, virologically suppressed adults who switched treatments, and adults with mild-to-moderate renal impairment. Research also suggests TAF-based treatment in the form of E/C/F/TAF improves renal and bone laboratory parameters when compared with TDF-based treatment in the form of E/C/F/TDF, or Stribild. – by David Jwanier