Abstract
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 μg albinterferon every 4 weeks or 900, 1200, 1500, or 1800 μg 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-μg 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 212-218 |
| Number of pages | 7 |
| Journal | Clinical Gastroenterology and Hepatology |
| Volume | 7 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2009 |
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ASJC Scopus subject areas
- Hepatology
- Gastroenterology
Cite this
Safety and Antiviral Activity of Albinterferon Alfa-2b in Prior Interferon Nonresponders With Chronic Hepatitis C. / Nelson, David R.; Rustgi, Vinod; Balan, Vijayan; Sulkowski, Mark S.; Davis, Gary L.; Muir, Andrew J.; Lambiase, Louis R.; Dickson, Rolland; Weisner, Russell H.; Fiscella, Michele; Cronin, Patrick W.; Pulkstenis, Erik; McHutchison, John G.; Subramanian, G. Mani.
In: Clinical Gastroenterology and Hepatology, Vol. 7, No. 2, 02.2009, p. 212-218.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and Antiviral Activity of Albinterferon Alfa-2b in Prior Interferon Nonresponders With Chronic Hepatitis C
AU - Nelson, David R.
AU - Rustgi, Vinod
AU - Balan, Vijayan
AU - Sulkowski, Mark S.
AU - Davis, Gary L.
AU - Muir, Andrew J.
AU - Lambiase, Louis R.
AU - Dickson, Rolland
AU - Weisner, Russell H.
AU - Fiscella, Michele
AU - Cronin, Patrick W.
AU - Pulkstenis, Erik
AU - McHutchison, John G.
AU - Subramanian, G. Mani
PY - 2009/2
Y1 - 2009/2
N2 - 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 μg albinterferon every 4 weeks or 900, 1200, 1500, or 1800 μg 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-μg 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.
AB - 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 μg albinterferon every 4 weeks or 900, 1200, 1500, or 1800 μg 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-μg 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.
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U2 - 10.1016/j.cgh.2008.10.035
DO - 10.1016/j.cgh.2008.10.035
M3 - Article
VL - 7
SP - 212
EP - 218
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
SN - 1542-3565
IS - 2
ER -