A study presented at the International Liver Congress™ 2017 held April 19-23 in Amsterdam, The Netherlands found that treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) or sofosbuvir/velpatasvir (SOF/VEL) led to significant improvement in patient-reported outcomes (PROs) in patients with hepatitis C virus (HCV) with cirrhosis.1
Chronic HCV affects approximately 71 million people globally, and a significant percentage will develop liver damage.2 HCV treatment has been completely transformed since the first direct-acting antivirals (DAAs) were approved in 2011 by the US Food and Drug Administration (FDA).
“Treatment of HCV with the new anti-viral agents is associated with a 98% sustained virologic response or HCV cure — this is a clear indication for clinical benefit of these treatment regimens,” said lead study investigator Zobair Younossi, MD, executive director of the Center for Liver Diseases at Inova Fairfax Hospital and professor of medicine at Virginia Commonwealth University. “On the other hand, the impact of these treatments on patient experiences has not been assessed,” he told Infectious Disease Advisor.
Dr Younossi and colleagues compared PROs of patients with chronic HCV with (n=718) and without (n=1190) cirrhosis who were taking SOF/VEL/VOX, SOF/VEL, or placebo as part of the POLARIS trials. Outcomes were compared at baseline and following treatment with:
- Placebo (152 non-cirrhosis; 51 cirrhosis)
- SOF/VEL for 12 weeks (700 non-cirrhosis; 262 cirrhosis)
- SOF/VEL/VOX for 8 or 12 weeks (1056 non-cirrhosis; 405 cirrhosis)
The findings show an overall sustained virologic response (SVR) of 94.3% in the SOF/VEL and SOF/VEL/VOX groups for both types of patients at 12 weeks. In addition, the following outcomes were observed in the patients with cirrhosis.
- Significantly lower baseline PRO scores compared with patients without cirrhosis (by up to −10.7 points on a 0-100 PRO scale; P <.05 for 24/26 PRO scores)
- Significant PRO improvement (by +1.3 to +14.1 points, P <.05) after both treatment regimens, which was greater than the improvement in patients without cirrhosis given the same treatment
- PRO improvements persisted after treatment with both regimens (+2.1 to +15.6 points by post-treatment week 4; +2.0 to +15.6 by week 12; +3.3 to +17.5 by week 24; P <.05)
- No improvement was seen in PROs as a result of placebo (all P >.05)
- After adjusting for confounders, receiving antiviral treatment rather than placebo was found to be associated with PRO improvement of +4.2 to +11.0 points (all P <.05)
“This study supports [the theory] that these treatments have comprehensive benefits by improving clinical outcomes as well as patient experience,” said Dr Younossi. “Improvement of PROs is not only related to achieving SVR but also improvement of liver function that will further improve PROs.”
- Younossi ZM, Stepanova M, Jacobson I, et al. High efficacy is accompanied with substantial gains in patient reported outcomes in cirrhotic patients with chronic hepatitis C treated with sofosbuvir (SOF), velpatasvir with or without voxilaprevir (VOX): data from POLARIS 1, 2, 3 and 4. Presented at: The International Liver Congress™ 2017. Amsterdam, The Netherlands; April 19-23, 2017. Abstract LBP-544.
- Hepatitis C Fact Sheet. World Health Organization. http://www.who.int/mediacentre/factsheets/fs164/en Updated April 2017. Accessed May 4, 2017.