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

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, n1⁄450) or placebo (n1⁄450) 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 ChildePugh 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; p1⁄40.036). 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; p1⁄40.044). However, the beneficial effects of viusid were wholly observed among patients with ChildePugh classes B or C, but not among patients with ChildePugh 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; p1⁄40.046). 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.

Article focus

  • Hepatitis C virus (HCV)-related decompensated cirrhotic patients have a poor therapeutic response and reduced tolerance to the current standard of care therapy.
  • Therapeutic goals in these patients should be directed towards reducing liver-related morbidity and mortality, and the need for liver transplantation.
  • Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties that could modulate the histological pattern of CHC, especially inflammation and fibrosis, in an attempt to halt disease progression and consequently improve liver function and liver-related morbidity and mortality, and prevent development of hepatocellular carcinoma (HCC).

Key messages

  • The administration of viusid to HCV-related decompensated cirrhotic patients induced a significant improvement of overall survival, a significant reduction in the disease progression and development of HCC.
  • The benefit of viusid was also seen in the secondary end point of worsening of the prognostic scores such as Model for End-Stage Liver Disease and ChildePugh scores.
  • The viusid effects on survival and disease progression were selective for patients with advanced stage of liver disease (ChildePugh B or C).
  • Viusid was well tolerated, and only minor transient adverse events such as nausea and diarrhoea were reported.

Strengths and limitations of this study

  • The main strength of this study was to demonstrate that Viusid improves overall clinical outcomes (survival, HCC and disease progression) in cirrhotic patients who have failed to achieve sustained virological response with standard of care, and these benefits appear to be more prominent in patients with poorer liver function (ChildePugh B or C).
  • The study was designed with a small sample size.
  • Further multicentre and large-scale studies are needed to corroborate the impact of viusid on the clinical outcomes in patients with HCV-related decompensated cirrhosis.

Full details of this clinical study are available in the “Clinical studies” section of the Viusid eLeaflet.

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