Efficacy and safety of pegylated interferon combined with ribavirin for the treatment of older patients with chronic hepatitis C.
BACKGROUND
The present study evaluated the efficacy and safety of pegylated interferon (PegIFN)/ribavirin treatment in elderly patients with hepatitis C virus (HCV) infection.


METHODS
Seventy elderly patients with hepatitis C virus (HCV) infection (group A; age, > or = 65 years) and 140 sex- and HCV genotype-matched controls (group B; age, 50-64 years) were allocated to receive a PegIFN-alpha-2a/ribavirin standard-of-care regimen.


RESULTS
Group A had a significantly higher rate of treatment discontinuation (21.4% vs 6.4%; P = .001) and grade 3 or 4 adverse events (34.3% vs 20%; P = .002) than group B. In intention-to-treat analysis, the sustained virologic response (SVR) rate was substantially lower in group A than in group B (67.1% vs 78.6%; P = .07). The inferiority of the SVR rate in group A was observed among patients with HCV genotype 1 (HCV-1) (51.9% vs 75.9%; P = .03) but not among patients with HCV genotype 2 or 3 (HCV-2/3) (76.7% vs 80.2%; P = .65). Among patients in group A who had a rapid virologic response, those infected with HCV-1 and those infected with HCV-2/3 had similar SVR rates (80% and 87.9%, respectively). For patients receiving treatment for >80% of its expected duration, SVR rates were similar between the 2 groups (80.4% vs 82.6%, respectively), regardless of viral genotype.


CONCLUSIONS
Older patients with HCV infection, especially those in the subgroup infected with HCV-1, had a greater frequency of adverse events and poorer adherence to the standard-of-care regimen, which may be the major reason for treatment inferiority.


BACKGROUND
Clinicaltrials.gov identifier NCT00629824 .
Huang
Chung-Feng
CF
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Graduate Institute of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.
Yang
Jeng-Fu
JF
Dai
Chia-Yen
CY
Huang
Jee-Fu
JF
Hou
Nai-Jen
NJ
Hsieh
Ming-Yen
MY
Lin
Zu-Yau
ZY
Chen
Shinn-Cherng
SC
Hsieh
Ming-Yuh
MY
Wang
Liang-Yen
LY
Chang
Wen-Yu
WY
Chuang
Wan-Long
WL
Yu
Ming-Lung
ML
D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D016022:Case-Control Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data; D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a