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Gilead Presents Multiple HCV and HBV Data at Liver Congress

Gilead Sciences Inc. GILD presented results from several phase II and phase III studies that are evaluating its two experimental, pangenotypic, fixed-dose combination therapies including Sovaldi/velpatasvir and Sovaldi/velpatasvir plus GS-9857 for the treatment of chronic hepatitis C virus (HCV) infection. In addition, the company announced new data evaluating the use of Harvoni in adolescents aged 12 to 17.

Also, the company presented data from a couple of phase III studies on tenofovir alafenamide (TAF) for the treatment of chronic HBV infection. Data were presented at The International Liver Congress.

Pangenotypic Regimens Show Encouraging SVR12 Rates

Results from the open-label phase III ASTRAL-5 study evaluating once-daily Sovaldi with velpatasvir for 12 weeks in patients with HCV genotype 1-6 who are co-infected with HIV demonstrated that the combination was found to be well-tolerated and resulted in high SVR12 rates. Overall, the SVR12 rate was 95% while it was 100% and 97% in patients with cirrhosis and prior treatment-failure, respectively.

We note that the Sovaldi/velpatasvir combination is under priority review in the U.S. with a response expected by Jun 28. It is also under review in the EU.

Gilead also presented encouraging data from three phase II studies (Studies 1168 and 1169 and TRILOGY-3) on Sovaldi/velpatasvir plus GS-9857. Based on these data, a fixed-dose combination of Sovaldi/velpatasvir/GS-9857 is being evaluated in four phase III studies – POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4. We note that the combination enjoys Breakthrough Therapy status in the U.S. for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.

Meanwhile, data from a phase II study on Harvoni in genotype 1 HCV-infected adolescents aged 12 to 17 demonstrated that Harvoni is well tolerated and resulted in high SVR12 in this patient population. Harvoni is currently also being evaluated in a pediatric population of children aged 3 to 11.

TAF Positive in Phase III HBV Studies

Gilead announced detailed 48-week results from two large phase III studies (Studies 108 and 110) evaluating the use of once-daily TAF (25 mg) in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infection.

Both the randomized, double-blind, 96-week studies met their primary endpoints. In the studies, it was observed that TAF was non-inferior to Viread, another Gilead drug, based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. Meanwhile, the improvement in renal and bone laboratory safety parameters was better in the TAF arm than Viread.

We note that TAF is currently under FDA review for the treatment of adults with chronic HBV infection. A response is expected by Nov 11. Gilead has also filed regulatory applications for TAF both in the EU and Japan.

Gilead is a Zacks Rank #1 (Strong Buy) stock. Other equally ranked stocks in the health care sector are AMAG Pharmaceuticals, Inc. AMAG, Emergent BioSolutions, Inc. EBS  and Anika Therapeutics Inc. ANIK.

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