title: Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection.
abstract: OBJECTIVE
  To examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r) ± ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection.
  
  
  METHODS
  Patients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25 mg QD) and ABT-450/r (200/100 mg QD) ± RBV for 12 weeks. Primary efficacy endpoint was HCV RNA < lower limit of quantitation (LLOQ) from week 4 through 12. Sustained virologic response 12 weeks post-treatment (SVR12) was a secondary endpoint.
  
  
  RESULTS
  Sixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was<LLOQ from week 4 through 12 in 10 (100%; 95% CI 69-100), 9 (90%; 56-100), and 7 (70%; 35-93) receiving the RBV-containing regimen and 9 (90%; 56-100), 8 (80%; 44-97), and 2 (18%; 2-52) receiving the RBV-free regimen. Among genotype 1-, 2-, and 3-infected patients, respectively, SVR12 was achieved by 10 (100%), 8 (80%), and 5 (50%) receiving the RBV-containing regimen, and 6 (60%), 6 (60%), and 1 (9%) receiving the RBV-free regimen. The most common adverse events were fatigue, nausea, and headache. One patient discontinued due to an adverse event.
  
  
  CONCLUSIONS
  In this study, ombitasvir and ABT-450/r ± RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.
authors.affiliation: The Texas Liver Institute, University of Texas Health Science Center, 607 Camden, San Antonio, TX 78215, USA. Electronic address: lawitz@txliver.com.
authors.forename: Eric
authors.initials: E
authors.lastname: Lawitz
authors.affiliation: Parkway Medical Center, 1160 Huffman Road, Birmingham, AL 35215, USA. Electronic address: dgregs@gmail.com.
authors.forename: Greg
authors.initials: G
authors.lastname: Sullivan
authors.affiliation: Funadación de Investigación, Avenida Munoz Rivera 998, Rio Piedras, Puerto Rico 00927, USA. Electronic address: mrodrigueztorres@fdipr.com.
authors.forename: Maribel
authors.initials: M
authors.lastname: Rodriguez-Torres
authors.affiliation: Medical Associates Research Group, 8008 Frost Street, Suite 200, San Diego, CA 92123, USA. Electronic address: michael.bennett@marginc.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Bennett
authors.affiliation: The Texas Liver Institute, University of Texas Health Science Center, 607 Camden, San Antonio, TX 78215, USA. Electronic address: poordad@txliver.com.
authors.forename: Fred
authors.initials: F
authors.lastname: Poordad
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: mudra.kapoor@abbvie.com.
authors.forename: Mudra
authors.initials: M
authors.lastname: Kapoor
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: prajakta.badri@abbvie.com.
authors.forename: Prajakta
authors.initials: P
authors.lastname: Badri
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: andrew.campbell@abbvie.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Campbell
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: lino.rodrigues@abbvie.com.
authors.forename: Lino
authors.initials: L
authors.lastname: Rodrigues
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: yiran.hu@abbvie.com.
authors.forename: Yiran
authors.initials: Y
authors.lastname: Hu
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: tami.pilotmatias@abbvie.com.
authors.forename: Tami
authors.initials: T
authors.lastname: Pilot-Matias
authors.affiliation: AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: regis.vilchezbonilla@abbvie.com.
authors.forename: Regis A
authors.initials: RA
authors.lastname: Vilchez
mesh_terms: D000328:Adult; D000368:Aged; D000813:Anilides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology; D006801:Humans; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013449:Sulfonamides; D016896:Treatment Outcome; D014633:Valine; D019562:Viral Load / Q000187:drug effects
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D002219:Carbamates; D003521:Cyclopropanes; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C586094:ombitasvir; D012254:Ribavirin; D011392:Proline; D014633:Valine; C585405:paritaprevir
keywords: HCV genotype 2; HCV genotype 3; Hepatitis C virus; Interferon-free therapy; SVR(12); SVR(24); Sustained virologic response