ASTRAL studies: New combination yields encouraging patient-reported outcomes
SAN DIEGO — Treatment with velpatasvir/sofosbuvir was associated with improvements in a number of patient self-reported quality of life measures, according to findings presented at Digestive Disease Week 2016.
Zobair M. Younossi, MD, of the Center for Liver Disease in the Department of Medicine at Inova Fairfax Hospital in Falls Church, Va., and colleagues aimed to compare patient-reported outcomes (PROs) during and after treatment with velpatasvir/sofosbuvir (Gilead Sciences) with those reported by patients treated with Sovaldi (sofosbuvir, Gilead Sciences) and ribavirin. Eligible participants had genotype 2 and 3 HCV and were participants in the ASTRAL-2 and ASTRAL-3 trials.
Zobair M. Younossi
“Genotype 3 presents a difficult challenge in terms of treatment,” Younossi said. “We don’t have a lot of patient-reported data for [velpatasvir/sofosbuvir].”
There were 818 patients included in the analysis; 33% for genotype 2 and 67% for genotype 3. Patients were treated for 12 or 24 weeks. SVR12 rates were above 90% for patients with genotype 2 and 3 disease who were treated with velpatasvir/sofosbuvir for 12 weeks as well as for genotype 2 patients treated with sofosbuvir and ribavirin for 12 weeks. Patients treated for 24 weeks with sofosbuvir and ribavirin had slightly lower SVR12 rates, at around 80%.
Patient-reported outcomes were measured using four instruments: SF-36, FACIT-F (a fatigue-specific metric), CLDQ-HCV and WPAI:SHP (a work-specific metric). These questionnaires were completed at baseline, during treatment, and up to 24 weeks follow up.
By the fourth week of treatment, nearly half of the PRO domains showed significant improvement among patients treated with velpatasvir/sofosbuvir, according to Younossi. The increase was nearly 10 points on a 100-point scale. These improvements increased to +11.6 by treatment week 8 (P < .05 for 15/23 PROs) and to +13.3 by treatment week 12 (P < .05 for all but two outcomes).
“By the end of treatment in the [velpatasvir/sofosbuvir] group, you start to see improvement in every measure of patient reported quality of life,” he said.
Patients treated with sofosbuvir and ribavirin, conversely, demonstrated improvements in around one-quarter of the outcome measures but decrements in other domains at week 4 of treatment, according to Younossi. “With ribavirin, you see a slight decline in quality of life around 4 weeks, and then you see an improvement,” he said. However, at 4 weeks after treatment, these decrements had resolved. “By post-treatment week 4, we see substantial improvement of PROs regardless of the regimen used.”
Younossi added that the improvements in PROs continue beyond week 12 and through to week 24.
Multivariable analysis results indicated that the use of velpatasvir/sofosbuvir independently predicted improvements in self-reported outcomes. “In almost all categories, there was improvement,” Younossi said. “These PRO improvements occur early into treatment and are sustained after treatment completion.”
Younossi ZM, et al. Abstract #499. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.
Disclosures: Younossi reports associations with AbbVie, Bristol-Myers Squibb, Gilead and Intercept.