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Results from a Phase 3 clinical trial, Study 109, assessing Gilead Science's (GILD -0.4%) next generation offering for the treatment of HIV-1 infection showed that it was non-inferior (no worse than) to tenofovir disoproxil fumarate (TDF)-based regimens such as Stribild at week 48. Additionally, the study demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL. The data were presented at the eighth IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada.
- The product candidate is a once-daily single tablet combination of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF). The value proposition of the new combo pill is comparable antiviral efficacy to TDF at one tenth the dose which mitigates unwanted stress on the bones and kidneys. This makes it a more desirable therapeutic option for long term use.
- Data from Study 109 show that patients receiving E/C/F/TAF experienced a cure rate (SVR12) of 97% compared to 93% for the TDF cohort. The rates of virologic failure were 1.0% for TAF versus 1.3% for TDF. General safety was similar.
- The company has three NDAs under review at the FDA for TAF products, one for two fixed-dose combination F/TAFs (200 mg/10 mg and 200/25 mg), one for E/C/F/TAF and one for the combination of emtricitabine 200mg, TAF and Janssen's (NYSE:JNJ) rilpivirine 25 mg (R/F/TAF). The FDA has announced PDUFA dates for E/C/F/TAF (November 5) and F/TAF (April 7, 2016). The NDA for R/F/TAF was submitted on July 1 so a PDUFA won't be assigned until the agency accepts the application for review.