Table 5. Randomized Controlled Trials with Long-term Clinical Outcomes in Patients with Hepatitis C Infection after Treatment with Interferon*

Study, Year
(Reference)
Patients Analyzed (n) and Duration of Followup Interventions Long-Term Outcomes Internal Validity Applicability to Screening
Nishiguchi, 2001129

90

Mean 8.7 y

a) INF-alfa 6 MU 3 times weekly for 24 wk

b) Symptomatic treatment

a vs. b

Hepatocellular carcinoma: 27% vs. 73% (P<0.001); adjusted RR 0.256 [95% CI, 0.125-0.522])

Death: 11% vs. 58% (P<0.001); adjusted RR 0.135 [95% CI, 0.049-0.372])

Adjusted RR for progression to Child B cirrhosis: 0.250 (0.124-0.505)

Fair

Not blinded

Unclear

Required elevated ALT and liver biopsy consistent with active cirrhosis; incidence of hepatocellular cancer and death much higher in untreated Japanese populations than in the United States

Bernardinello, 1999130

61

Up to 5 y

a) Intramuscular INF-beta 6 MU 3 times weekly for 6 mo then 3 M 3 times weekly for 6 mo

b) No treatment

a vs. b (not statistically significant)

Cumulative probability of decompensation: 24% vs. 35%
Risk for death: 9% vs. 4.4%

Hepatocellular carcinoma: 5.3 % (2 cases) vs. 4.3% (1 case)

Fair

Attrition, crossovers, and contamination not reported; possibility of differential loss to followup not reported

Unclear

Required elevated ALT and liver biopsy findings consistent with active cirrhosis

* Numbers in square brackets are 95% CIs.
ALT = alanine aminotransferase; INF = interferon; RR = relative risk.

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