PAmAb is safe, well tolerated, and bioavailable after a single intramuscular or intravenous dose, which supports further clinical development of PAmAb as a novel therapeutic agent for inhalational anthrax.
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-IFN␣)-2a 180 g one time per week (qwk), or alb-IFN 900 or 1,200 g once every two weeks (q2wk), or 1,200 g 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 intentionto-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 g q2wk, 55.5% (61/110) with 1,200 g q2wk, and 50.9% (59/116) with 1,200 g q4wk, and 57.9% (66/114) with PEG-IFN␣-2a (P ؍ 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 g q2wk, 18.2% with 1,200 g q2wk and 12.1% with 1,200 g q4wk, and 6.1% with PEG-IFN␣-2a (P ؍ 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatmentassociated missed workdays were significantly lower with alb-IFN 900 g q2wk versus PEG-IFN␣-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-IFN␣-2a. (HEPATOLOGY 2008;48:407-417.) Abbreviations: AE, adverse event; ANC, absolute neutrophil count; CHC, chronic hepatitis C; CI, confidence interval; EVR12, early virologic response at week 12; HCV, hepatitis C virus; HRQOL, IFN␣, interferon alfa; LOD, limit of detection; LOQ, limit of quantitation; peginterferon alfa; qwk, one time per week; q2wk, once every two weeks; q4wk, once every four weeks; RBV, ribavirin; RVR4, rapid virologic response at week 4; SVR, sustained virologic response; ULN, upper limit of normal. From the 1 J.W. Frankfurt, Germany; 2 University of British Columbia, Vancouver, Canada; Paris, France; 4 Monash University Medical School, Victoria, Australia;5 University of Alberta, Edmonton, Canada; 6 Hadassah University, Jerusalem, Israel;7 Medical University of Bialystok, Poland; Romania; Prague, Czech Republic;10 University of Manitoba, Winnipeg, Canada; 11 Human Genome Sciences Inc., Rockville, MD;and 12 Division of Gastroenterology, Duke Clinical Research Institute, Durham, NC. Received February 21, 2008; accepted April 25, 2008. Supported by Human Genome Sciences Inc., Rockville, MD, and Novartis Pharma AG, Basel, Switzerland (S.Z., E.M.Y., Y.B., S.P., V.G.B., D.S., R.F., V.R., M.G., K.K., J.G.M. Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany. E-mail: zeuzem@em.uni-frankfurt.de; fax: 49-(0)69-6301-6448. Copyright © 2008 [3][4][5][6][7][8] Approximately 70% ...
BACKGROUND & AIMS A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. METHODS In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μgto 900 μg, impacting 38% of this treatment arm. RESULTS By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%–88.6%), 79.8% (95% confidence interval, 74.9%–84.1%), and 80.0% (95% confidence interval, 75.1%–84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg(P = .009) and 1200 μg(P = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0–F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%–8%) and severe (13%–16%) adverse events, and discontinuations owing to adverse events (3.6%–5.5%). CONCLUSION Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.
albIFN 900 μg every 2 weeks showed comparable efficacy, with similar serious/severe AE rates, although with a higher discontinuation rate, vs Peg-IFNα-2a in patients with chronic HCV genotype 1.
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