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

Abstract

ObjectivesViusid 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.DesignA 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.ResultsViusid 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.ConclusionsThe 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 numberhttp://ClinicalTrials.gov (NCT00502086).

Ocoxin® oral solution slows down tumor growth in an experimental model of colorectal cancer metastasis to the liver in Balb/c mice

“…It was synthesized by combining two products, Viusid ® and Ocoxin ® . The Viusid component has been tested in different clinical trials showing beneficial effects in patients suffering from chronic hepatitis C and cirrhosis ( 10 , 11 ). Moreover, OOS antitumor effects have validated in vitro and in vivo preclinical breast cancer models ( 12 ).…”

Effect of zinc treatment on clinical outcomes in patients with liver cirrhosis: A systematic review and meta-analysis

“…Only two studies (Takuma et al[ 17 ] and Vilar Gomez et al[ 18 ]) reported severity of cirrhosis with mean Child Pugh scores of 6.0 and 6.3 and MELD scores of 11.8 and 12.9.…”

“…Vilar Gomez et al[ 18 ] evaluated the efficacy of Viusid for 96 wk in reducing mortality in 100 patients with hepatitis C-related decompensated cirrhosis. Viusid was chosen because it is a nutritional supplement with recognized anti-inflammatory and antioxidant properties.…”

“…No studies reported 1-year mortality, which was the primary outcome of this systematic review. Three studies (Bresci et al[ 19 ], Hayashi et al[ 20 ], and Takuma et al[ 17 ]) reported 6-mo survival and one (Vilar Gomez et al[ 18 ]) reported 2-year survival. There is a substantial amount of heterogeneity across the selected study trials in terms of zinc formulation, dosage and patient characteristics.…”

“…We used the National Institutes of Health risk of bias tools to assess the quality of included studies[ 16 ]. Two studies (Vilar Gomez et al[ 18 ] and Hayashi et al[ 20 ]) were of low risk of bias and two studies of uncertain risk of bias (Bresci et al[ 19 ] and Takuma et al[ 17 ]). Risk of bias assessments are presented in Supplementary Table 1.…”