Safety and Antiviral Activity of Albinterferon Alfa-2b in Prior Interferon Nonresponders With Chronic Hepatitis C

被引：33

作者：

Nelson, David R. ^{[1
]}

Rustgi, Vinod ^{[2
]}

Balan, Vijayan ^{[3
]}

Sulkowski, Mark S. ^{[4
]}

Davis, Gary L. ^{[5
]}

Muir, Andrew J. ^{[6
]}

Lambiase, Louis R. ^{[7
]}

Dickson, Rolland C. ^{[8
]}

Weisner, Russell H. ^{[9
]}

Fiscella, Michele ^{[11
]}

Cronin, Patrick W. ^{[11
]}

Pulkstenis, Erik ^{[11
]}

Mchutchison, John G. ^{[10
]}

Subramanian, G. Mani ^{[11
]}

机构：

[1] Univ Florida, Coll Med, Gainesville, FL 32610 USA

[2] Metropolitan Res, Fairfax, VA USA

[3] Mayo Clin, Scottsdale, AZ USA

[4] Johns Hopkins Univ, Baltimore, MD USA

[5] Baylor Univ, Med Ctr, Dallas, TX USA

[6] Duke Univ, Durham, NC USA

[7] Univ Florida, Jacksonville, FL USA

[8] Mayo Clin, Jacksonville, FL 32224 USA

[9] Mayo Clin, Rochester, MN USA

[10] Duke Clin Res Inst, Durham, NC USA

[11] Human Genome Sci Inc, Rockville, MD USA

来源：

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2009年 / 7卷 / 02期

关键词：

PEGINTERFERON ALPHA-2A; FUSION PROTEIN; PLUS RIBAVIRIN;

D O I：

10.1016/j.cgh.2008.10.035

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background & Aims: Pegylated interferon alfa-2a/2b is used in combination with ribavirin to treat patients with chronic hepatitis C (CHC), although many do not achieve a sustained virologic response (SVR). Albinterferon alfa-2b, a recombinant protein consisting of interferon alfa-2b fused to human albumin, may increase drug exposure. This phase 2 study evaluated the safety/efficacy of albinterferon in CHC patients who had not responded to interferon-based regimens. Methods: A total of 115 patients were assigned to 5 groups given 1200 mu g albinterferon every 4 weeks or 900, 1200, 1500, or 1800 mu g every 2 weeks, plus oral ribavirin, for 48 weeks. The primary efficacy end point was achievement of an SVR after 24 weeks. Treatment was extended to 72 weeks for 6 slow responders who were negative for hepatitis C virus RNA after 24 weeks. Results: The types of adverse events were similar across groups; the overall discontinuation rate as a result of adverse events was 10.4%. Reductions in absolute neutrophil counts were less frequent in the every 4 weeks group and comparable among the every 2 weeks groups. The overall SVR rate was 17% (11% for previous nonresponders to pegylated interferon-alfa/ribavirin with genotype 1 infection). An SVR occurred in 3 of 6 slow responders by 72 weeks. The greatest reductions in hepatitis C virus RNA in nonresponders to pegylated interferon-alfa/ribavirin with genotype 1 infection were observed in the 1800-mu g group. Conclusions: In patients with CHC who did not respond to interferon-based regimens, higher doses of albinterferon had significant early antiviral activity and a low incidence of adverse events, with the types of adverse events similar to those observed with interferon.

引用

页码：212 / 218

页数：7

共 18 条

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