Interferon alpha with ribavirin for the treatment of chronic hepatitis C in non-responders or relapsers to interferon monotherapy.
BACKGROUND
A more effective therapy for chronic hepatitis C virus-infected patients is needed.


OBJECTIVE
To evaluate the efficacy, tolerance and timing of response to interferon alpha plus ribavirin in 60 patients with no response or reactivation after interferon alpha alone.


METHODS
Sixty patients, 42 non-responders and 18 relapsers, received 3 million units three times weekly of interferon alpha-2b plus 1-1.2 g ribavirin daily, for 6 months. Basal biochemical and virological (HCV RNA and genotype) parameters were determined. Clinical examination, recording adverse effects, and laboratory tests, including viraemia, were carried out at 1, 2, 3 and 6 months.


RESULTS
A significant (P < 0.001) progressive decrease of HCV RNA and alanine transaminase (ALT) levels was observed during treatment. On finalizing the sixth month, 42 patients (70%) had normal ALT and 26 (43.3%) were HCV RNA negative. Of these 26 complete responders, in 20 the viraemia was undetectable by the third month, while a late clearance at the sixth month of treatment was observed in six patients. Response rates were higher in previous responders to interferon alone (P < 0.05). Mild adverse effects appeared in 46 patients (79.6%), but only three were withdrawn due to serious side-effects. Significantly (P < 0.001), haemoglobin and leucocytes decreased, and bilirubin, ferritin and uric acid increased in the first month of treatment, with no changes thereafter.


CONCLUSIONS
Interferon alpha plus ribavirin progressively decreased HCV RNA and ALT levels, achieving a complete response in the six months of treatment in 26 (43.3%) patients. This combined therapy was well tolerated.
Moreno-Monteagudo
J A
JA
Liver Unit, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Spain. morenootero@hotmail.com
Fernández-Bermejo
M
M
García-Buey
L
L
Sanz
P
P
Iacono
L O
LO
García-Monzón
C
C
Borque
M J
MJ
Moreno-Otero
R
R
D000328:Adult; D000410:Alanine Transaminase / Q000032:analysis; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004351:Drug Resistance; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D012008:Recurrence; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D012254:Ribavirin; D000410:Alanine Transaminase