AIMTo evaluate efficacy/safety of hepatitis C virus (HCV) protease inhibitor boceprevir with pegylated interferon (PEG-IFN) alfa and weight-based ribavirin (RBV) in a phase 3 trial. METHODSA prospective, multicenter, ...AIMTo evaluate efficacy/safety of hepatitis C virus (HCV) protease inhibitor boceprevir with pegylated interferon (PEG-IFN) alfa and weight-based ribavirin (RBV) in a phase 3 trial. METHODSA prospective, multicenter, phase 3, open-label, single-arm study of PEG-IFN alfa, weight-based RBV, and boceprevir, with a PEG-IFN/RBV lead-in phase was performed. The HCV/human immunodeficiency virus coinfected study population included treatment naïve (TN) and treatment experienced (TE) patients. Treatment duration ranged from 28 to 48 wk dependent upon response-guided criteria. All patients had HCV Genotype 1 with a viral load > 10000 IU/mL. Compensated cirrhosis was allowed. Sample size was determined to establish superiority to historical (PEG-IFN plus RBV) rates in sustained viral response (SVR). RESULTSA total of 257 enrolled participants were analyzed (135 TN and 122 TE). In the TN group, 81.5% were male and 54.1% were black. In the TE group, 76.2% were male and 47.5% were white. Overall SVR12 rates (HCV RNA P = 0.002). Among the TN, SVR12 was 42.1% among whites and 27.4% among blacks (P = 0.09). CONCLUSIONThe trial met its hypothesis of improved SVR compared to historical controls but overall SVR rates were low. All-oral HCV treatments will mitigate these difficulties.展开更多
基金Princy N Kumar MD and Susan Vajda RN - Georgetown University (Site 1008) Grant N/ADonna Mc Gregor and Richard Green - Northwestern University CRS (Site 2701) Grant AI 069471, UL1 RR02574+43 种基金Metro Health CRS (Site 2503) Grant 1U01AI069501-01Mark A Rodriguez RN BSN and Geyoul Kim RN BS - Washington University Therapeutics CRS (Site 2101) Grant AI69439Graham Ray and Jacob Langness - University of Colorado CRS (Site 6101) Grant2UM1AI069432, UL1 TR001082Roger Bedimo and Holly Wise - Trinity Health and Wellness Center CRS (Site 31443) Grant U01 AI069471Michelle Saemann RN BSN and Carl J Fichtenbaum MD - University of Cincinnati (Site 2401) Grant UM1AI068636Jorge L Santana Bagur MD FIDSA and Daniel Casiano RN BSN - Puerto Rico AIDS/CRS (Site 5401) Grant 5UM1AI069415UCSD Antiviral Research Center CRS (Site 701) Grant UM1AI069432Valery Hughes FNP and Todd Stroberg RN - Weill Cornell Chelsea CRS (Site 7804) Grant 5UM1 AI069419, UL1 TR000457Roberto C Arduino and Martine Diez - Houston AIDS Research Team CRS (Site 31473) Grant 2UM1 AI069503Pola de la Torre MD and Yolanda Smith BA - Cooper University Hospital (Site 31476) Grant AI069503-01Ioana Bica MD and Betsy Adams RN - Boston Medical Center (Site 104) Grant 5U01A1069472Ilene Wiggins RN and Andrea Weiss BPharm - Johns Hopkins University CRS (Site 201) Grants 2UM1 AI069465 and UL1TR001079Institute for Clinical and Translational ResearchUniversity of Washington AIDS CRS (Site 1401) Grant UM1AI069481Pamela Poethke RN and Deborah Perez RN - the Miriam Hospital CRS (Site 2951) Harvard/Boston/Providence CTU Grant UM1-AI069412Mary Adams RN and Christine Hurley RN - University of Rochester (Site 31787) Grant UM1 AI069511, UL1 TR000042Debbie Slamowitz RN and Sandra Valle PA-C - Stanford University (Site 501) Grant AI 069556Ramakrishna Prasad MD MPH and Lisa Klevens RN BSN - University of Pittsburgh (Site 1001) Grant UM1AI069494Dr. Susan Koletar, MD and Kathy Watson RN - Ohio State University (Site 2301) Grant UM1AI069494Benigno Rodriguez MD MSc FIDSA and Kristen Allen RN BSN - Case CRS (Site 2501) Grant AI69501Peter Gordon MD and Jolene Noel-Connor RN - Columbia University P and S CRS (Site 30329) Grant 5UM1AI069470-10Supported in part by Columbia University's CTSA grant UL1 TR000040 from NCATS/ NIHBronx-Lebanon Hosp. Ctr. CRS (Site 31469) Grant 1U01AI069503-01Daniel Nixon DO Ph D and Vicky Watson RN - Virginia Commonwealth University CRS (Site 31475) Grant UM1-AI069503Shobha Swaminathan and Baljinder Singh - Rutgers New Jersey Medical School CRS (Site 31786) Grant AI069419-10Connie Funk RN MPH and Fred R Sattler MD - University of Southern California CRS (Site 1201) Grants AI069428 and AI27673Beverly E Sha MD and Tondria Green RN BSN ACRN - Rush University Medical Center CRS (Site 2702) Grant U01 AI069471Linda Makohon RN BSN and Leslie Faber RN BSN - Henry Ford Health System (Site 31472) Grant 5UM1A1069503, B40465Susan Blevins RN MS ANP-C and Catherine Kronk BA - Chapel Hill CRS (Site 3201) Grants UM1 AI069423, CTSA: 1UL1TR001111, CFAR: P30 AI50410Vicki Bailey RN and Fred Nicotera Vanderbilt Therapeutics CRS (Site 3652) Grant 2UM1AI069439-08supported in part by the Vanderbilt CTSA grant TR000445 from NIHAlabama CRS (Site 31788) Grant 1U01AI069452-01Dr. Debika Bhattacharya MD and Maria Palmer PA - UCLA Care Center CRS (Site 601) Grant AI069424Jacquelin Granholm and Susanna Naggie- Duke University (Site 1601) Grant U01-AI069484Eric S Daar and Sadia Shaik - Harbor-UCLA (Site 603) Grant AI 069424, UL1 TR000124Denver Public Health CRS (Site 31470)Wayne State Univ. CRS (Site 31478) Grant 1U01AI069503-01Annie Luetkemeyer MD and Anna Smith RN - UCSF AIDS CRS (Site 801) CTU Grant 5UM1AI069496Pablo Tebas MD and Yan Jiang RN Penn Therapeutics CRS (Site 6201) Grant ACTG: UMIA-069534-08, CFAR: 5-P30-AI-045008-15Amy Sbrolla RN and Teri Flynn ANP-BC - Massachusetts General Hospital CRS (Site 101) Grant UM1AI068636Paul Sax MD and Cheryl Keenan RN BC - Brigham and Women’s Hospital (Site 107) Grant UM1AI069412Clifford Gunthel MD and Ericka R Patrick RN MSN - Emory-CDC CTU The Ponce de Leon CRS (Site 5802) Grant 1U01AI069418-01Emory University Center For AIDS Research P30AI050409Weill Cornell Uptown CRS (Site 7803) Grant UM1AI069419
文摘AIMTo evaluate efficacy/safety of hepatitis C virus (HCV) protease inhibitor boceprevir with pegylated interferon (PEG-IFN) alfa and weight-based ribavirin (RBV) in a phase 3 trial. METHODSA prospective, multicenter, phase 3, open-label, single-arm study of PEG-IFN alfa, weight-based RBV, and boceprevir, with a PEG-IFN/RBV lead-in phase was performed. The HCV/human immunodeficiency virus coinfected study population included treatment naïve (TN) and treatment experienced (TE) patients. Treatment duration ranged from 28 to 48 wk dependent upon response-guided criteria. All patients had HCV Genotype 1 with a viral load > 10000 IU/mL. Compensated cirrhosis was allowed. Sample size was determined to establish superiority to historical (PEG-IFN plus RBV) rates in sustained viral response (SVR). RESULTSA total of 257 enrolled participants were analyzed (135 TN and 122 TE). In the TN group, 81.5% were male and 54.1% were black. In the TE group, 76.2% were male and 47.5% were white. Overall SVR12 rates (HCV RNA P = 0.002). Among the TN, SVR12 was 42.1% among whites and 27.4% among blacks (P = 0.09). CONCLUSIONThe trial met its hypothesis of improved SVR compared to historical controls but overall SVR rates were low. All-oral HCV treatments will mitigate these difficulties.
