Effect of viral suppression on hepatic venous pressure gradient in hepatitis C with cirrhosis and portal hypertension |
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| Authors: | N. Afdhal G. T. Everson J. L. Calleja G. W. McCaughan J. Bosch D. M. Brainard J. G. McHutchison S. De‐Oertel D. An M. Charlton K. R. Reddy T. Asselah E. Gane M. P. Curry X. Forns |
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| Affiliation: | 1. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA;2. University of Colorado Denver, Aurora, Colorado, USA;3. Hospital U. Puerta de Hierro, CIBEREHD, Universidad Autonoma, Madrid, Spain;4. Royal Prince Alfred Hospital, Centenary Research Institute, University of Sydney, Sydney, NSW, Australia;5. Liver Unit, Hospital Clinic, IDIBAPS, CIBEREHD, Barcelona, Spain;6. Swiss Liver Center, Inselspital, Bern University, Bern, Switzerland;7. Gilead Sciences, Inc., Foster City, California, USA;8. Intermountain Medical Center, Murray, Utah, USA;9. University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA;10. H?pital Beaujon, Department of Hepatology, AP‐HP, INSERM UMR1149 and University Paris‐Diderot, Clichy, France;11. University of Auckland, Auckland, New Zealand |
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| 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). |
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| Keywords: | advanced liver disease cirrhosis decompensated cirrhosis direct‐acting antivirals hepatic venous pressure gradient portal hypertension |
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