Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV–cirrhotic patients
Direct-acting antivirals (DAAs) show high efficacy and safety in HCV–cirrhotic patients, but most maintain clinically significant portal hypertension after sustained virological response (SVR). Non-invasive Baveno and expanded-Baveno criteria can identify patients without high-risk gastroesophageal varices (GEV) who have no need for endoscopic surveillance. However, data after SVR are scarce. We performed a multicenter study to evaluate SVR effects over GEV and diagnostic accuracy of non-invasive criteria after SVR.
HCV–cirrhotic patients receiving DAAs and baseline endoscopic evaluation were included (November 2014–October 2015). GEV were classified as low risk (LR-GEV) (< 5 mm) or high risk (HR-GEV) (≥ 5 mm or with risk signs). Transient elastography (TE) and endoscopy were performed during follow-up.
SVR was achieved in 230 (93.1%) of 247 included patients, 151 (65.7%) with endoscopic follow-up. Among 64/151 (42.4%) patients without baseline GEV, 8 (12.5%) developed GEV after SVR. Among 50/151 (33.1%) with baseline LR-GEV, 12 (24%) developed HR-GEV. Patients with GEV progression showed TE ≥ 25 kPa before treatment (64.7%) or ≥ 20 kPa after SVR (66.7%). Only 6% of patients without GEV and LSM < 25 kPa before treatment, and 10% of those with baseline LSM < 25 kPa and LSM < 20 kPa after SVR showed GEV progression after 36 months. The negative predictive value of Baveno and expanded-Baveno criteria to exclude HR-GEV was maintained after SVR (100% and 90.7%, respectively).
HCV–cirrhotic patients can develop HR-GEV after SVR. Surveillance is especially recommended in those with GEV before antiviral treatment. Baveno and expanded-Baveno criteria can be safely applied after SVR. https://clinicaltrials.gov: NCT02758509.
KeywordsHepatitis C Sustained virological response Cirrhosis Varices Baveno
Hepatic venous pressure gradient
Clinically significant portal hypertension
Sustained virological response
Hepatitis C virus
Direct acting antivirals
High-risk gastroesophageal varices
Liver stiffness measurement
Body mass index
Low risk gastroesophageal varices
Negative predictive value
Human immunodeficiency virus
Hepatitis B virus
End of treatment
Serious adverse events
- 95% CI
95% confidence interval
MP: data collection, analysis and interpretation of data; statistical analysis; drafting and critical revision of the manuscript. MCL, XT, SL, MV, RMM, HM, TS, MM, AG, SL: data collection and critical revision of the manuscript. JAC: study concept and design; data collection; statistical analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript; and study supervision.
Compliance with ethical standards
Conflicts of interest
MCL: advisory fees from Janssen, MSD, AbbVie, Gilead and BMS. XT: Speaker fees from AbbVie, MSD and Gilead; advisory board for Gilead and MSD. SL: lecture fees from Gilead, AbbVie, Merck, BMS and Janssen. MV: lecture fees from Gilead Sciences, AbbVie and MSD. RMM: Speaker fees from Gilead, AbbVie, Merck, BMS, Janssen and Intercept. TS: Speaker fees from Gilead, AbbVie, and MSD. MM: lecture fees from Gilead, AbbVie and Merck. SL: speaker and consultant fees from Gilead, AbbVie and Janssen. JAC: lecture fees from Bristol Myers Squibb, Gilead Sciences, Roche/Genentech and Jansen; the remaining authors declare no conflict of interest.
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