Abstract
Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNα) monotherapy vs Peg-IFNα and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C. Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNα monotherapy (180 μg weekly) or Peg-IFNα and ribavirin, up to the maximum tolerated dose, for 48 weeks. Results: Early virological response (EVR, i.e., HCV-RNA ≥ 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INFα dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day. Conclusions: Peg-IFNα-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin.
| Original language | English |
|---|---|
| Pages (from-to) | 1009-1017 |
| Number of pages | 9 |
| Journal | Journal of Hepatology |
| Volume | 46 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 2007 |
Fingerprint
Keywords
- HCV
- Liver transplantation
- Peginterferon alfa-2a
- Ribavirin
- Treatment
ASJC Scopus subject areas
- Gastroenterology
Cite this
A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C. / Angelico, Mario; Petrolati, Alessandra; Lionetti, Raffaella; Lenci, Ilaria; Burra, Patrizia; Donato, Maria Francesca; Merli, Manuela; Strazzabosco, Mario; Tisone, Giuseppe.
In: Journal of Hepatology, Vol. 46, No. 6, 06.2007, p. 1009-1017.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C
AU - Angelico, Mario
AU - Petrolati, Alessandra
AU - Lionetti, Raffaella
AU - Lenci, Ilaria
AU - Burra, Patrizia
AU - Donato, Maria Francesca
AU - Merli, Manuela
AU - Strazzabosco, Mario
AU - Tisone, Giuseppe
PY - 2007/6
Y1 - 2007/6
N2 - Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNα) monotherapy vs Peg-IFNα and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C. Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNα monotherapy (180 μg weekly) or Peg-IFNα and ribavirin, up to the maximum tolerated dose, for 48 weeks. Results: Early virological response (EVR, i.e., HCV-RNA ≥ 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INFα dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day. Conclusions: Peg-IFNα-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin.
AB - Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNα) monotherapy vs Peg-IFNα and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C. Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNα monotherapy (180 μg weekly) or Peg-IFNα and ribavirin, up to the maximum tolerated dose, for 48 weeks. Results: Early virological response (EVR, i.e., HCV-RNA ≥ 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INFα dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day. Conclusions: Peg-IFNα-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin.
KW - HCV
KW - Liver transplantation
KW - Peginterferon alfa-2a
KW - Ribavirin
KW - Treatment
UR - http://www.scopus.com/inward/record.url?scp=34247605934&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34247605934&partnerID=8YFLogxK
U2 - 10.1016/j.jhep.2006.12.017
DO - 10.1016/j.jhep.2006.12.017
M3 - Article
VL - 46
SP - 1009
EP - 1017
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 6
ER -