Abstract |
We assessed the efficacy of interferon (IFN) plus ribavirin over 24 or 48 weeks for the retreatment of patients with chronic hepatitis C who had relapsed or did not respond to a previous course of IFN. One-hundred and twenty patients (69 non-responders and 51 relapsers) were randomly assigned to receive IFN-alpha2b (3 million units thrice weekly) plus ribavirin (1,000-1,200 mg per day) for 24 weeks (group A: 58 patients) or 48 weeks (group B: 62 patients). Treatment was discontinued at week 12 if the alanine aminotransferase (ALT) level remained elevated. The rate of sustained response was 15.5% in group A and 37.1% in group B (P = 0.013). Relapsers treated for 48 weeks had a sustained response rate of 66.6% compared with a sustained response rate of only 25% in those treated for 24 weeks (P = 0.004). Moreover, a sustained response was seen in 14.3% of non-responders treated for 48 weeks and in 8.8% of those treated for 24 weeks (P = 0.71). Fifty-three per cent of patients with a normal ALT level and undetectable hepatitis C virus (HCV) RNA at week 12 had a sustained response compared with 14% of those who were HCV RNA positive at week 12 (P < 0.001). Independent predictive factors of sustained response were: therapy for 48 weeks (P = 0.0026), relapse after IFN treatment (P = 0.0006), loss of HCV RNA at week 12 (P = 0.0008) and HCV genotype non-1 (P = 0.024). Hence, in patients with chronic hepatitis C who failed to respond to a previous course of IFN monotherapy, combination therapy with IFN plus ribavirin for 48 weeks seems to be more effective than IFN plus ribavirin for 24 weeks.
|
Authors | J Enríquez, A Gallego, X Torras, T Pérez-Olmeda, M Diago, V Soriano, M S Luján, J García-Samaniego |
Journal | Journal of viral hepatitis
(J Viral Hepat)
Vol. 7
Issue 6
Pg. 403-8
(Nov 2000)
ISSN: 1352-0504 [Print] England |
PMID | 11115050
(Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Antiviral Agents
- Interferon alpha-2
- Interferon-alpha
- RNA, Viral
- Recombinant Proteins
- Ribavirin
- Alanine Transaminase
|
Topics |
- Adult
- Alanine Transaminase
(blood)
- Antiviral Agents
(adverse effects, therapeutic use)
- Drug Therapy, Combination
- Female
- Hepacivirus
(genetics, isolation & purification)
- Hepatitis C, Chronic
(drug therapy, virology)
- Humans
- Interferon alpha-2
- Interferon-alpha
(adverse effects, therapeutic use)
- Male
- Middle Aged
- RNA, Viral
(blood)
- Recombinant Proteins
- Recurrence
- Ribavirin
(adverse effects, therapeutic use)
- Treatment Failure
- Treatment Outcome
- Viral Load
|