The effect of interferon alfa and ribavirin combination therapy in naive patients with chronic hepatitis C.
BACKGROUND
Chronic hepatitis C may lead to cirrhosis and hepatocellular carcinoma in a subset of patients. Because response rates with interferon alfa therapy are unsatisfactory, new therapies are needed.


METHODS
We conducted a three-arm, randomized trial in 45 interferon-naive men (mean age 40.6 +/- 12 years) with chronic hepatitis C to compare treatments: group A, ribavirin alone (15 mg/kg daily for 6 months); group B, interferon alone (3 MU thrice weekly for 6 months); and group C, interferon plus ribavirin at the above doses. Histologic outcomes of therapy were assessed by pretreatment and post-treatment liver biopsies.


RESULTS
In group A, alanine aminotransferase levels normalized during therapy in 66% of those with HCV-1b and 34% of those with HCV-2a, but all patients relapsed after treatment ended. In group B, alanine aminotransferase levels normalized during treatment in 66%, 75%, and 100% of patients infected with HCV-1b, HCV-2a, and HCV-3, respectively; however, a sustained response was noted in only 25% of those with HCV-3. In group C, a sustained normalization of alanine aminotransferase with negative serum HCV RNA was seen in 20% of those with HCV-1b, 40% of those with HCV-2a, and 75% of those with HCV-3 12 months after therapy. One year after therapy ended, group C demonstrated a significant sustained response (47%) as well as a significant reduction in piecemeal necrosis and portal inflammation (p < 0.05).


CONCLUSIONS
Combination therapy was significantly superior to ribavirin or interferon monotherapy in producing a sustained response in interferon-naive patients with chronic hepatitis C (p < 0.05). The results of our study suggest that ribavirin potentiates the effect of interferon therapy in chronic hepatitis C.
Chemello
L
L
Clinica Medica 2, University of Padova, Italy.
Cavalletto
L
L
Bernardinello
E
E
Guido
M
M
Pontisso
P
P
Alberti
A
A
D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000145:classification / Q000302:isolation & purification; D006526:Hepatitis C / Q000628:therapy*; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012016:Reference Values; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*
D000998:Antiviral Agents; D007370:Interferon Type I; D011994:Recombinant Proteins; D012254:Ribavirin; D001219:Aspartate Aminotransferases