Abstract
The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting of interferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naïve patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFNα)-2a 180 μg one time per week (qwk), or alb-IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA <10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG-IFNα-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG-IFNα-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 μg q2wk versus PEG-IFNα-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNα-2a.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 407-417 |
| Number of pages | 11 |
| Journal | Hepatology |
| Volume | 48 |
| Issue number | 2 |
| DOIs | |
| State | Published - Aug 2008 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Hepatology
Cite this
Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. / Zeuzem, Stefan; Yoshida, Eric M.; Benhamou, Yves; Pianko, Stephen; Bain, Vincent G.; Shouval, Daniel; Flisiak, Robert; Rehak, Vratislav; Grigorescu, Mircea; Kaita, Kelly; Cronin, Patrick W.; Pulkstenis, Erik; Subramanian, G. Mani; McHutchison, John G.
In: Hepatology, Vol. 48, No. 2, 08.2008, p. 407-417.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C
AU - Zeuzem, Stefan
AU - Yoshida, Eric M.
AU - Benhamou, Yves
AU - Pianko, Stephen
AU - Bain, Vincent G.
AU - Shouval, Daniel
AU - Flisiak, Robert
AU - Rehak, Vratislav
AU - Grigorescu, Mircea
AU - Kaita, Kelly
AU - Cronin, Patrick W.
AU - Pulkstenis, Erik
AU - Subramanian, G. Mani
AU - McHutchison, John G.
PY - 2008/8
Y1 - 2008/8
N2 - The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting of interferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naïve patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFNα)-2a 180 μg one time per week (qwk), or alb-IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA <10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG-IFNα-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG-IFNα-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 μg q2wk versus PEG-IFNα-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNα-2a.
AB - The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting of interferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naïve patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFNα)-2a 180 μg one time per week (qwk), or alb-IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA <10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG-IFNα-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG-IFNα-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 μg q2wk versus PEG-IFNα-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNα-2a.
UR - http://www.scopus.com/inward/record.url?scp=49649089488&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=49649089488&partnerID=8YFLogxK
U2 - 10.1002/hep.22403
DO - 10.1002/hep.22403
M3 - Article
C2 - 18666223
AN - SCOPUS:49649089488
VL - 48
SP - 407
EP - 417
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 2
ER -