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.