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DAA therapy improves patient-reported outcomes despite cirrhosis, ribavirin use
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BOSTON — All patients with hepatitis C, even those with decompensated cirrhosis, experienced improved patient-reported outcomes after treatment with direct-acting antivirals with or without ribavirin, according to findings presented at The Liver Meeting 2016.
“Although on-treatment [patient-reported outcomes] improvements are more notable with ribavirin-free regimens, post-SVR improvements are similar,” Zobair M. Younossi, MD, MPH, chairman of the department of medicine at Inova Fairfax Hospital and vice president for research at Inova Health System in Falls Church, Va., said during his presentation. “By the end of treatment, you see that all patients regardless of whether their cirrhotic, non-cirrhotic or decompensated cirrhotics, they actually gain benefits in terms of their PROs.”
Younossi presented findings from four patient-reported outcome (PRO) questionnaires utilized during the ASTRAL series of studies. The questionnaires included SF-36, CLDQ-HCV, FACIT-F and WPAI:HCV. There were three patient groups represented in the analysis: patients without cirrhosis, patients with compensated cirrhosis and patients with decompensated cirrhosis. Treatment-emergent changes in PROs were studied in two groups: those who received ribavirin and those who did not.
The study included 1,701 patients treated with Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) with or without ribavirin, Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) or Sovaldi (sofosbuvir, Gilead Sciences) plus ribavirin for 12 or 24 weeks; 1,112 without cirrhosis; 338 with compensated cirrhosis; 251 with decompensated cirrhosis. Of the 488 patients treated with ribavirin, 401 received sofosbuvir alone plus ribavirin and 87 received sofosbuvir/velpatasvir plus ribavirin. The 1,213 patients treated with sofosbuvir/ledipasvir did not receive ribavirin.
Baseline data indicated that patients with decompensated cirrhosis were more likely to have depression and fatigue (P < .002), while patients without cirrhosis were more likely to be employed and treatment-naive (both P < .0001). Cirrhosis was associated with a significantly lower baseline PRO score — up to –33.5 points on a universal 0 to 100 scale — compared with patients without cirrhosis (P < .05 for all but three domains).
At treatment end, patients receiving ribavirin in all three cirrhosis categories experienced similar changes in PROs (P > .01 for all). These changes included moderate improvements in some PROs (up to 11.8; P < .05) and moderate decrements in others (–7.1; P < .05 for mental health outcomes).
At 4 weeks after the end of therapy, an improvement of up to 12.6 points from baseline was reported, regardless of cirrhosis status (P > .01). A similar result was reported between baseline and 12 weeks after treatment (up to 14.2 points) and 24 weeks after treatment (17.1 points; P > .01 for both comparisons).
“PRO improvements were seen across disease severity with decompensated cirrhotics experiencing the best and greatest improvement of PRO scores during treatment with sofosbuvir/velpatasvir and this really tells you that the comprehensive outcome with these patients with these drugs we see high SVRs of 98% but also in this context PRO improvement,” Younossi said.
Younossi noted that patients with decompensated cirrhosis treated with sofosbuvir/ledipasvir experienced the greatest benefit in terms of PROs, showing significant improvement in 17 of the 26 PROs. Results from 26 outcome measures indicated that patients without cirrhosis improved by 2.3 points, patients with compensated cirrhosis improved by 4.8 points and patients with decompensated cirrhosis improved by 7.3 points (P < .05). Sustained improvement remained by SVR12 follow-up in the decompensated group (5.8) and the compensated group or those without cirrhosis (4.1), according to the results (P < .05).
Multivariable analysis results showed that patients with compensated cirrhosis yielded an additional improvement in terms of treatment-emergent outcomes between 2.3 and 5.0 points (P < .05 for all) for patients treated with sofosbuvir/velpatasvir. For those with decompensated cirrhosis treated with sofosbuvir/velpatasvir, an additional improvement of 5.5 to 9.1 points (P < .002 for all) was reported in the multivariable model.
“The other point that’s really important to remember … is that if you follow these patients for another 12 weeks to week 24, that improvement in PRO continues, suggesting that all the benefit of cure is not achieved by 12 weeks of follow-up,” Younossi said. “These improvements that you see are regardless disease severity in most of the categories that we’ve seen. … Patients with mild disease get as much benefit as those with severe disease.” – Katrina Altersitz and Rob Volansky
Reference:
Younossi YM, et al. Abstract #24. Presented at: The Liver Meeting; Nov. 11-15, 2016; Boston.
Disclosures: Younossi reports no relevant financial disclosures.