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ARTICLE

Epclusa: What Have We Learned?

JAN 01, 2017 | AMANDA BINKLEY, PHARMD, AAHIVP, AND ASHLEY SHERIDAN, PHARMD

ASTRAL-4 

In order to evaluate the efficacy of sofosbuvir/ velpatasvir among patients with decompensated cirrhosis, both previously treated and treatment-naïve, ASTRAL-4 was initiated. ASTRAL-4 was a phase-3, open-label trial evaluating patients with genotypes 1 through 6, both previously treated and treatmentnaïve, who had decompensated cirrhosis, defined as Child-Pugh-Turcotte class B.14 The primary endpoint of the evaluation was SVR12. Eligible patients were randomized to one of three treatment arms: sofosbuvir/ velpatasvir for 12 weeks, sofosbuvir/velpatasvir plus ribavirin for 12 weeks, or sofosbuvir/velpatasvir for 24 weeks. As expected, the majority of patients had genotype 1 (78%), followed by genotype 3 (15%), genotype 4 (3%), and genotype 6 (<1%), with no patients included with genotype 5.14
 
SVR12 rates in patients with genotype 1 were highest among those who received sofosbuvir/velpatasvir plus ribavirin (96%), followed by those who received sofosbuvir/velpatasvir for 24 weeks (92%), and patients who received sofosbuvir/velpatasvir for 12 weeks (88%). Similarly, in patients with genotype 3, SVR12 was highest among patients who were treated with sofosbuvir/ velpatasvir plus ribavirin, achieving SVR12 rates of 85% compared with 50% of patients who received sofosbuvir/ velpatasvir alone for both 12 or 24 weeks achieving SVR12.14
 
When looking at the ASTRAL-1 through -3 trials collectively, there were 1,035 patients treated with sofosbuvir/velpatasvir for 12 weeks, with 98% achieving a SVR12. In addition, ASLTRAL-4 demonstrated higher SVR rates in those with Child-Pugh-Turcotte class B cirrhosis who received sofosbuvir/velpatasvir plus ribavirin for 12 weeks than those who received sofosbuvir/velpatasvir for 12 or 24 weeks. The results from the ASTRAL trials showed that treatment with a 12-week course of sofosbuvir/velpatasvir was highly effective in achieving high viral cure rates regardless of HCV genotype.15
 

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