title: Effect of viral suppression on hepatic venous pressure gradient in hepatitis C with cirrhosis and portal hypertension.
abstract: Portal hypertension is a predictor of liver-related clinical events and mortality in patients with hepatitis C and cirrhosis. The effect of interferon-free hepatitis C treatment on portal pressure is unknown. Fifty patients with Child-Pugh-Turcotte (CPT) A and B cirrhosis and portal hypertension (hepatic venous pressure gradient [HVPG] >6 mm Hg) were randomized to receive 48 weeks of open-label sofosbuvir plus ribavirin at Day 1 or after a 24-week observation period. The primary endpoint was sustained virologic response 12 weeks after therapy (SVR12) in patients who received ≥1 dose of treatment. Secondary endpoints included changes in HVPG, laboratory parameters, and MELD and CPT scores. A subset of patients was followed 48 weeks posttreatment to determine late changes in HVPG. SVR12 occurred in 72% of patients (33/46). In the 37 patients with paired HVPG measurements at baseline and the end of treatment, mean HVPG decreased by -1.0 (SD 3.97) mm Hg. Nine patients (24%) had ≥20% decreases in HVPG during treatment. Among 39 patients with pretreatment HVPG ≥12 mm Hg, 27 (69%) achieved SVR12. Four of the 33 (12%) patients with baseline HVPG ≥12 mm Hg had HVPG <12 mm Hg at the end of treatment. Of nine patients with pretreatment HVPG ≥12 mm Hg who achieved SVR12 and completed 48 weeks of follow-up, eight (89%) had a ≥20% reduction in HVPG, and three reduced their pressure to <12 mm Hg. Patients with chronic HCV and compensated or decompensated cirrhosis who achieve SVR can have clinically meaningful reductions in HVPG at long-term follow-up. (EudraCT 2012-002457-29).
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
authors.forename: N
authors.initials: N
authors.lastname: Afdhal
authors.affiliation: University of Colorado Denver, Aurora, Colorado, USA.
authors.forename: G T
authors.initials: GT
authors.lastname: Everson
authors.affiliation: Hospital U. Puerta de Hierro, CIBEREHD, Universidad Autonoma, Madrid, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Royal Prince Alfred Hospital, Centenary Research Institute, University of Sydney, Sydney, NSW, Australia.
authors.forename: G W
authors.initials: GW
authors.lastname: McCaughan
authors.affiliation: Liver Unit, Hospital Clinic, IDIBAPS, CIBEREHD, Barcelona, Spain.|Swiss Liver Center, Inselspital, Bern University, Bern, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Bosch
authors.affiliation: Gilead Sciences, Inc., Foster City, California, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Brainard
authors.affiliation: Gilead Sciences, Inc., Foster City, California, USA.
authors.forename: J G
authors.initials: JG
authors.lastname: McHutchison
authors.affiliation: Gilead Sciences, Inc., Foster City, California, USA.
authors.forename: S
authors.initials: S
authors.lastname: De-Oertel
authors.affiliation: Gilead Sciences, Inc., Foster City, California, USA.
authors.forename: D
authors.initials: D
authors.lastname: An
authors.affiliation: Intermountain Medical Center, Murray, Utah, USA.
authors.forename: M
authors.initials: M
authors.lastname: Charlton
authors.affiliation: University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
authors.forename: K R
authors.identifier: 0000-0002-4898-7778
authors.initials: KR
authors.lastname: Reddy
authors.affiliation: Hôpital Beaujon, Department of Hepatology, AP-HP, INSERM UMR1149 and University Paris-Diderot, Clichy, France.
authors.forename: T
authors.initials: T
authors.lastname: Asselah
authors.affiliation: University of Auckland, Auckland, New Zealand.
authors.forename: E
authors.initials: E
authors.lastname: Gane
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
authors.forename: M P
authors.initials: MP
authors.lastname: Curry
authors.affiliation: Liver Unit, Hospital Clinic, IDIBAPS, CIBEREHD, Barcelona, Spain.
authors.forename: X
authors.initials: X
authors.lastname: Forns
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006503:Hepatic Veins / Q000503:physiopathology*; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy / Q000821:virology*; D006801:Humans; D006975:Hypertension, Portal / Q000209:etiology* / Q000503:physiopathology*; D008103:Liver Cirrhosis / Q000150:complications* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D017082:Portal Pressure; D012367:RNA, Viral; D000072230:Sustained Virologic Response; D013997:Time Factors; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral
keywords: advanced liver disease; cirrhosis; decompensated cirrhosis; direct-acting antivirals; hepatic venous pressure gradient; portal hypertension