Clinical trial: peg-interferon alfa-2b and ribavirin for the treatment of genotype-1 hepatitis C recurrence after liver transplantation.
BACKGROUND
Treatment of hepatitis C virus (HCV) recurrence after liver transplantation (LT) is difficult with low response rates.


OBJECTIVE
To assess the safety and efficacy of pegylated-interferon (PEG-IFN) alfa-2b + ribavirin (RBV) in patients with post-LT recurrent genotype-1 HCV and to establish stopping rules according to response.


METHODS
Fifty-three patients with post-LT HCV recurrence were enrolled. Patients received PEG-IFN alfa-2b 1.0 micro/kg/week plus RBV 8-10 mg/kg/day for 24 weeks. Those with 'early virological response at week 24' (EVR24) continued treatment for 24 weeks (group A). Patients without EVR24 were randomized to continue (group B) or to discontinue (group C).


RESULTS
Overall sustained virological response (SVR) was 26% (14/53). Alanine aminotransferase, rapid virological response, EVR12, EVR24, undetectable serum HCV-RNA at weeks 12 (cEVR12) and 24 (cEVR24) were related to SVR. cEVR12 and cEVR24 (OR: 14.7; 95% CI: 2.02-106.4) were independent predictors of SVR. All patients with SVR, had cEVR12. No patient in groups B and C achieved end-of-treatment response. One patient in group B had SVR.


CONCLUSIONS
Pegylated-interferon alfa-2b was effective in one of four of patients with HCV genotype 1 after LT. Treatment should be discontinued in patients with no virological response at week 12. Further studies are needed to evaluate whether a longer treatment period may be beneficial in patients with > or =2 log10 drop in HCV-RNA at week 24.
Lodato
F
F
Department of Digestive Diseases and Internal Medicine, Azienda Ospedaliero-Universitaria Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
Berardi
S
S
Gramenzi
A
A
Mazzella
G
G
Lenzi
M
M
Morelli
M C
MC
Tame
M R
MR
Piscaglia
F
F
Andreone
P
P
Ballardini
G
G
Bernardi
M
M
Bianchi
F B
FB
Biselli
M
M
Bolondi
L
L
Cescon
M
M
Colecchia
A
A
D'Errico
A
A
Del Gaudio
M
M
Ercolani
G
G
Grazi
G L
GL
Grigioni
W
W
Lorenzini
S
S
Pinna
A D
AD
Ravaioli
M
M
Roda
E
E
Sama
C
C
Vivarelli
M
M
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D016031:Liver Transplantation / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000235:genetics; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D055502:Secondary Prevention; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b