Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial

Eduardo Vilar Gomez, Yoan Sanchez Rodriguez, Ana Torres Gonzalez, Luis Calzadilla Bertot, Enrique Arus Soler, Yadina Martinez Perez, Ali Yasells Garcia, Maria Del Rosario Abreu Vazquez, Eduardo Vilar Gomez, Yoan Sanchez Rodriguez, Ana Torres Gonzalez, Luis Calzadilla Bertot, Enrique Arus Soler, Yadina Martinez Perez, Ali Yasells Garcia, Maria Del Rosario Abreu Vazquez

Abstract

Objectives: Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis.

Design: A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child-Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks.

Results: Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child-Pugh classes B or C, but not among patients with Child-Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated.

Conclusions: The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV-related decompensated cirrhosis. Trial registration number http://ClinicalTrials.gov (NCT00502086).

Conflict of interest statement

Competing interests: None.

Figures

Figure 1
Figure 1
Flow of patients through the study. *Four patients with hepatocellular carcinoma (HCC) were not discontinued because diagnosis was made at the end of the treatment.
Figure 2
Figure 2
Kaplan–Meier curves for (A) survival and (B) time to disease progression according to Child–Pugh (CP) classes (A vs B or C). Time to disease progression was defined as the incidence of liver-related death, the development of hepatocellular carcinoma or the first occurrence or relapse (only for those patients with a previous history of hepatic decompensation) of at least one of the following clinical conditions: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome or upper-gastrointestinal bleeding secondary to portal hypertension. The CP score is a measure of the severity of liver disease. Numbers in parentheses show the number of events.
Figure 3
Figure 3
Kaplan–Meier estimates of the time to worsening of the (A) Child–Pugh (CP) and (B) Model for End-Stage Liver Disease (MELD) scores during the treatment. Numbers in parentheses show the number of events. The MELD and CP scores are measures of the severity of liver disease.

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