Clinical efficacy of Viusid in patients with cirrhosis of the liver secondary to chronic hepatitis C. Interim analysis of a randomized, controlled and double blind clinical trial Dr. Eduardo Vilar National Institute of Gastroenterology Havana, Cuba
Clinical efficacy of Viusid in patients withcirrhosis of the liver secondary to
chronic hepatitis C.Interim analysis of a randomized, controlled
and double blind clinical trial
Dr. Eduardo VilarNational Institute of GastroenterologyHavana, Cuba
Baseline characteristics of the patients
Characteristics Viusid(n=35)
Placebo(n=35)
Age – years, Mean ± SD* 59 ± 10 57.2 ± 8.7
Sex – no. (%)MaleFemale
16 (46%)19 (54%)
13 (37%)22 (63%)
Child Score – no. (%)†ABC
19 (49%)13 (50%)3 (50%)
20 (51%)13 (50%)2 (40%)
Child-Pugh score Mean ± SD 6.1 ± 1.2 6.2 ± 1.2
Alpha-fetoprotein μg/liter Mean ± SD 8.6 ± 1.1 7.9 ± 1.3
Alanine aminotransferase U/LMean ± SD 78.6 ± 48.3 78.9 ± 40.9
Aspartate aminotransferase U/LMean ± SD 89.8 ± 80.7 101.2 ± 88.5
Albumin – g/LMean ± SD 38.4 ± 3.5 38.1 ± 3.4
Bilirubin – μmol/L Mean ± SD 21.3 ± 15.6 21.1 ± 13.3
Creatinine – mg/dLMean ± SD 1.1 ± 0.3 1.02 ± 0.2
Hemoglobin – g/LMean ± SD 125 ± 12.7 126 ± 16
Platelet count per mm3
Mean ± SD 205 ± 43.2 199 ± 43.2
Prothrombin time - sec ‡Mean ± SD 4.9 ± 3 5 ± 3.7
White-cell count per mm3
Mean ± SD 6000 ± 1900 6670 ± 1800
* All values expressed with a plus/minus sign are means ± SD.† The Child-Pugh score (range, A=5-6; B=7-9; C=10-15, where 5 indicates goodliver function and 15 poor liver function) is a measure of the severity of liver disease.‡ The prothrombin time was evaluated as seconds upper control value.
Continuation
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
P<0.001
Kaplan-Meier estimates of acumulative incidence of ascites
Placebo
Viusid
SBP. Spontaneous Bacterial Peritonitis
Kaplan-Meier estimates of acumulative incidence of spontaneous bacterial peritonitis
Placebo
Viusid
HE. Hepatic Encephalopathy
Kaplan-Meier estimates of acumulative incidence of hepaticencephalopathy
Placebo
Viusid
Kaplan-Meier estimates of time to an increase in the Child-Pugh Score
Placebo
Viusid
Study summary
• At the end of 48-56 weeks of the treatment, mean change in hemoglobin
and albumin concentration were significantly higher in patients assigned to
Viusid treatment in comparison to the patients with placebo.
• Increased mean value of bilirrubin were observed at first weeks of
treatment in patients assigned to Viusid in comparison with the placebo
group, however, the mean values were significantly decreased and lower in
those patients treated with Viusid at 48 week of treatment.
• A notable decreasing in mean values of clinical score was observed
in those patients assigned to Viusid treatment in comparison with
those patents assigned to placebo.
• Increased mean value in Child-Pugh score were observed in those
patients treated with placebo as compared to Viusid during the 48
weeks of therapy.
• The cumulative incidence of ascites, spontaneous bacterial
peritonitis, hepatic encephalopathy and Child-Pugh score was higher
in patients assigned to placebo group as compared to Viusid during
the 48 weeks treatment period.