A prospective assessment of an 'a la carte' regimen of PEG-interferon alpha2b and ribavirin combination in patients with chronic hepatitis C using biochemical markers.
In therapy with standard interferon and ribavirin, five independent risk factors (RF) were predictive of relapse. The aim was to prospectively validate an a la carte regimen of pegylated interferon (PEG-IFN) alpha2b 1.5 microg/kg and ribavirin 11 mg/kg [PEG-IFN-ribavirin (PEG-IFN-R)], taking into account these five risk factors in order to determine whether to continue an additional 24 weeks of treatment in polymerase chain reaction (PCR) negative patients after 24 weeks. Treatment was stopped after 24 weeks in PCR positive patients. The same regimen was continued in PCR negative patients for an additional 24 weeks if patients had two or more RF. FibroTest and ActiTest assessed the impact of treatment on the histological features from baseline to end of follow-up. A total of 96 patients were included; 84 (87.5%) had at least two RF and 12 (12.5%) had no or one RF. A total of 70 patients were sustained virologic response (SVR; 73%), 19 were nonresponders (20%) and seven were relapsers (7%). The SVR in genotypes 2 or 3 was 85% (34/40) vs 64% in other genotypes (36/56; P = 0.02). There was a decrease (P = 0.003) in fibrosis as estimated by FibroTest, from 0.38 +/- 0.03 (mean +/- SE) at baseline to 0.33 +/- 0.03 at the 12-week follow-up, and a decrease in activity as estimated by ActiTest, from 0.49 +/- 0.02 to 0.19 +/- 0.03 (P < 0.0001). Improvement in activity was already significant at 12 weeks, even in virologic nonresponders. This study confirms that an a la carte regimen which takes into account not only genotype but also baseline viral load, fibrosis stage, gender and age, is efficient for the PEG-IFN-R combination. It achieves a 73% SVR and a significant decrease in fibrosis and activity as estimated by biochemical markers.
Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, Université Paris VI, Paris, France.
C
C
d'Arondel
M
M
Munteanu
J
J
Moussalli
V
V
Thibault
S
S
Naveau
A
A
Simon
D
D
Messous
R
R
Morra
C
C
Blot
T
T
Poynard
D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016632:Apolipoprotein A-I / Q000097:blood; D001663:Bilirubin / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006242:Haptoglobins / Q000032:analysis; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000511:alpha-Macroglobulins / Q000032:analysis; D005723:gamma-Glutamyltransferase / Q000097:blood
C505693:APOA1 protein, human; D000998:Antiviral Agents; D016632:Apolipoprotein A-I; D006242:Haptoglobins; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D000511:alpha-Macroglobulins; D011092:Polyethylene Glycols; D012254:Ribavirin; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase; C417083:peginterferon alfa-2b; D001663:Bilirubin