Abstract
Elderly patients with chronic hepatitis C cannot tolerate standard combination therapy of peginterferon and ribavirin, which remains the backbone of therapy in many countries, including Japan. The efficacy and safety of low-dose peginterferon α-2b in combination with low and escalating doses of ribavirin in older patients with high viral load genotype 1 were investigated in this randomized controlled trial. Thirty-two patients (age ≥60 years) were randomized into standard (group 1) or low (group 2) doses of peginterferon α-2b in combination with low and escalating doses of ribavirin. Patients were evaluated for safety and efficacy of treatment. There was a higher virological response rate in group 1 than in group 2. However, the response in men was higher than in women in the early treatment phase and 24 weeks after treatment (P=0.008). There was no significant difference between the two groups in the virological response rate in men and women. Completion of therapy was higher in group 2 than in group 1 (31% vs. 13%, P=0.200). Dose modification of ribavirin was less frequent in group 2 than in group 1 (69% vs. 88%, P=0.200). These data suggest that combination therapy with low-dose peginterferon plus low and escalating doses of ribavirin may be safer in older patients than that with standard dose peginterferon, without impairing the treatment response.
| Original language | English |
|---|---|
| Pages (from-to) | 2082-2089 |
| Number of pages | 8 |
| Journal | Journal of Medical Virology |
| Volume | 87 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Dec 1 2015 |
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Keywords
- Adverse event
- Dose modification
- Sustained virological response
- Treatment discontinuation
ASJC Scopus subject areas
- Virology
- Infectious Diseases
Cite this
Randomized trial of low-dose peginterferon α-2b plus low and escalating doses of ribavirin in older patients with chronic hepatitis C with high viral load genotype 1. / Iwasaki, Yoshiaki; Okamoto, Ryo Ichi; Ishii, Yasushi; Araki, Yasuyuki; Hashimoto, Noriaki; Yamamoto, Kazuhide.
In: Journal of Medical Virology, Vol. 87, No. 12, 01.12.2015, p. 2082-2089.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized trial of low-dose peginterferon α-2b plus low and escalating doses of ribavirin in older patients with chronic hepatitis C with high viral load genotype 1
AU - Iwasaki, Yoshiaki
AU - Okamoto, Ryo Ichi
AU - Ishii, Yasushi
AU - Araki, Yasuyuki
AU - Hashimoto, Noriaki
AU - Yamamoto, Kazuhide
PY - 2015/12/1
Y1 - 2015/12/1
N2 - Elderly patients with chronic hepatitis C cannot tolerate standard combination therapy of peginterferon and ribavirin, which remains the backbone of therapy in many countries, including Japan. The efficacy and safety of low-dose peginterferon α-2b in combination with low and escalating doses of ribavirin in older patients with high viral load genotype 1 were investigated in this randomized controlled trial. Thirty-two patients (age ≥60 years) were randomized into standard (group 1) or low (group 2) doses of peginterferon α-2b in combination with low and escalating doses of ribavirin. Patients were evaluated for safety and efficacy of treatment. There was a higher virological response rate in group 1 than in group 2. However, the response in men was higher than in women in the early treatment phase and 24 weeks after treatment (P=0.008). There was no significant difference between the two groups in the virological response rate in men and women. Completion of therapy was higher in group 2 than in group 1 (31% vs. 13%, P=0.200). Dose modification of ribavirin was less frequent in group 2 than in group 1 (69% vs. 88%, P=0.200). These data suggest that combination therapy with low-dose peginterferon plus low and escalating doses of ribavirin may be safer in older patients than that with standard dose peginterferon, without impairing the treatment response.
AB - Elderly patients with chronic hepatitis C cannot tolerate standard combination therapy of peginterferon and ribavirin, which remains the backbone of therapy in many countries, including Japan. The efficacy and safety of low-dose peginterferon α-2b in combination with low and escalating doses of ribavirin in older patients with high viral load genotype 1 were investigated in this randomized controlled trial. Thirty-two patients (age ≥60 years) were randomized into standard (group 1) or low (group 2) doses of peginterferon α-2b in combination with low and escalating doses of ribavirin. Patients were evaluated for safety and efficacy of treatment. There was a higher virological response rate in group 1 than in group 2. However, the response in men was higher than in women in the early treatment phase and 24 weeks after treatment (P=0.008). There was no significant difference between the two groups in the virological response rate in men and women. Completion of therapy was higher in group 2 than in group 1 (31% vs. 13%, P=0.200). Dose modification of ribavirin was less frequent in group 2 than in group 1 (69% vs. 88%, P=0.200). These data suggest that combination therapy with low-dose peginterferon plus low and escalating doses of ribavirin may be safer in older patients than that with standard dose peginterferon, without impairing the treatment response.
KW - Adverse event
KW - Dose modification
KW - Sustained virological response
KW - Treatment discontinuation
UR - http://www.scopus.com/inward/record.url?scp=84942983778&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84942983778&partnerID=8YFLogxK
U2 - 10.1002/jmv.24276
DO - 10.1002/jmv.24276
M3 - Article
C2 - 26010427
AN - SCOPUS:84942983778
VL - 87
SP - 2082
EP - 2089
JO - Journal of Medical Virology
JF - Journal of Medical Virology
SN - 0146-6615
IS - 12
ER -