A. Bellobuono et al., Should patients with early loss of serum HCV-RNA during alpha interferon therapy for chronic hepatitis C be treated for 6 or 12 months?, J HEPATOL, 30(1), 1999, pp. 8-13
Background/Aims: Retrospective studies have suggested that early loss of se
rum HCV-RNA predicts sustained response to alpha-interferon treatment in ch
ronic hepatitis C, but the optimal duration of therapy after loss of HCV-RN
A is not known. The aims of this study were: a) to prospectively evaluate t
he effectiveness of HCV-RNA testing after 1 month of alpha-interferon treat
ment in the prediction of sustained response, and b) to compare the efficac
y of 6 and 12 months of therapy in patients with a negative serum HCV-RNA t
est after the first month of treatment.
Methods: One hundred and thirty patients were administered interferon alpha
-2b at doses related to body weight (< or greater than or equal to 60 kg) a
nd to HCV genotype: 5 or 8 MU tiw for type 1, and 3 or 5 MU tiw for genotyp
es non-1. Serum HCV-RNA testing was performed using in-house nested RT-PCR
at month 1, at the end of treatment and 6 months afterwards. We considered
sustained response to be the maintenance of normal alanine aminotransferase
and negativity at serum HCV-RNA testing until the end of follow-up.
Results: Sustained response was observed in 2/72 (2.8%) patients with detec
table HCV-RNA after the initial month of therapy, in 8/30 (26.7%) patients
with early loss of HCV-RNA treated for 6 months and in 20/28 (71.4%) patien
ts treated for 12 months (p<0.01).
Conclusions: Serum HCV-RNA detectability after the first month is strongly
associated with a very poor chance of sustained response, and these cases s
hould be offered other treatments. Patients with early loss of HCV-RNA shou
ld complete a 12-month treatment, which appeared more effective than a 6-mo
nth treatment.