title: Effectiveness of All-Oral Antiviral Regimens in 996 Human Immunodeficiency Virus/Hepatitis C Virus Genotype 1-Coinfected Patients Treated in Routine Practice.
abstract: Large cohorts are needed to assess human immunodeficiency virus (HIV)/hepatitis C virus (HCV) real-world treatment outcomes. We examined the effectiveness of ledipasvir/sofosbuvir with or without ribavirin (LDV/SOF ± RBV) and ombitasvir/ paritaprevir/ritonavir plus dasabuvir (OPrD) ± RBV in HIV/HCV genotype 1 (GT1)-coinfected patients initiating HCV therapy in clinical practice.
  Observational intent-to-treat cohort analysis using the Veterans Affairs Clinical Case Registry to identify HIV/HCV GT1-coinfected veterans initiating 12 weeks of LDV/SOF ± RBV or OPrD ± RBV. Multivariate models of sustained virologic response (SVR) included age, race, cirrhosis, proton pump inhibitor (PPI) prescription, prior HCV treatment, body mass index, genotype subtype, and HCV treatment regimen.
  Nine hundred ninety-six HIV/HCV GT1-coinfected veterans initiated therapy: 757 LDV/SOF, 138 LDV/SOF + RBV, 28 OPrD, and 73 OPrD + RBV. Overall SVR was 90.9% (823/905); LDV/SOF 92.1% (631/685), LDV/SOF + RBV 86.3% (113/131), OPrD 88.9% (24/27), and OPrD + RBV 88.7% (55/62). SVR was 85.9% (176/205) and 92.4% (647/700) in those with and without cirrhosis (P = .006). SVR was similar between African Americans (90.5% [546/603]) and all others (91.7% [277/302]). PPI use with LDV/SOF ± RBV did not affect SVR (89.7% [131/146] with PPI and 91.5% [613/670] without PPI). Cirrhosis was predictive of reduced SVR (0.51 [95% confidence interval {CI}, .31-.87]; P = .01). Median creatinine change did not differ among patients receiving LDV/SOF and tenofovir disoproxil fumarate (TDF) without a protease inhibitor (PI) (0.18 [interquartile range {IQR}, 0.08-0.30]; n = 372), LDV/SOF and TDF/PI (0.17 [IQR, 0.04-0.30]; n = 100), and LDV/SOF without TDF (0.15 [IQR, 0.00-0.30]; n = 423).
  SVR rates in HIV/HCV GT1-coinfected patients were high. African American race or PPI use with LDV/SOF ± RBV was not associated with lower SVR rates, but cirrhosis was. Renal function did not worsen on LDV/SOF regimens with TDF.
authors.affiliation: 1 Department of Medicine, Veterans Affairs Greater Los Angeles Health Care System.|2 Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, and.
authors.forename: Debika
authors.initials: D
authors.lastname: Bhattacharya
authors.affiliation: 3Population Health Services, Department of Veterans Affairs, Palo Alto Health Care System, California.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Belperio
authors.affiliation: 3Population Health Services, Department of Veterans Affairs, Palo Alto Health Care System, California.
authors.forename: Troy A
authors.initials: TA
authors.lastname: Shahoumian
authors.affiliation: 3Population Health Services, Department of Veterans Affairs, Palo Alto Health Care System, California.
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Loomis
authors.affiliation: 1 Department of Medicine, Veterans Affairs Greater Los Angeles Health Care System.|2 Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, and.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Goetz
authors.affiliation: 3Population Health Services, Department of Veterans Affairs, Palo Alto Health Care System, California.
authors.forename: Larry A
authors.initials: LA
authors.lastname: Mole
authors.affiliation: 3Population Health Services, Department of Veterans Affairs, Palo Alto Health Care System, California.
authors.forename: Lisa I
authors.initials: LI
authors.lastname: Backus
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000813:Anilides / Q000008:administration & dosage / Q000627:therapeutic use; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use; D002219:Carbamates / Q000008:administration & dosage / Q000627:therapeutic use; D015331:Cohort Studies; D060085:Coinfection / Q000188:drug therapy* / Q000821:virology; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000627:therapeutic use; D005838:Genotype; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics*; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D011392:Proline / Q000031:analogs & derivatives; D012042:Registries; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000627:therapeutic use; D013449:Sulfonamides; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D014633:Valine; D014728:Veterans
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D001562:Benzimidazoles; D002219:Carbamates; D003521:Cyclopropanes; D005449:Fluorenes; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C000595958:ledipasvir, sofosbuvir drug combination; C586094:ombitasvir; D012254:Ribavirin; D011392:Proline; D014542:Uridine Monophosphate; D014633:Valine; C585405:paritaprevir; D000069474:Sofosbuvir
keywords: DAA; HCV; HIV; real-world