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Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV–cirrhotic patients

  • Marc Puigvehí
  • María-Carlota Londoño
  • Xavier Torras
  • Sara Lorente
  • Mercedes Vergara
  • Rosa Maria Morillas
  • Helena Masnou
  • Trinidad Serrano
  • Mireia Miquel
  • Adolfo Gallego
  • Sabela Lens
  • Jose Antonio CarriónEmail author
Original Article—Liver, Pancreas, and Biliary Tract

Abstract

Background

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.

Methods

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.

Results

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).

Conclusions

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.

Keywords

Hepatitis C Sustained virological response Cirrhosis Varices Baveno 

Abbreviations

GEV

Gastroesophageal varices

HVPG

Hepatic venous pressure gradient

CSPH

Clinically significant portal hypertension

SVR

Sustained virological response

HCV

Hepatitis C virus

DAAs

Direct acting antivirals

HR-GEV

High-risk gastroesophageal varices

LSM

Liver stiffness measurement

TE

Transient elastography

VL

Viral load

BMI

Body mass index

kPa

KiloPascals

LR-GEV

Low risk gastroesophageal varices

PC

Platelet count

NPV

Negative predictive value

HIV

Human immunodeficiency virus

HBV

Hepatitis B virus

SOF

Sofosbuvir

SMV

Simeprevir

LDV

Ledipasvir

DCV

Daclatasvir

RBV

Ribavirin

PTV/r/O/D

Paritaprevir/ritonavir/ombitasvir/dasabuvir

EOT

End of treatment

NR

Non-responders

SAEs

Serious adverse events

OR

Odds ratio

95% CI

95% confidence interval

LSM_b

Baseline LSM

LSM_f

Follow-up LSM

Notes

Author contribution

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.

Funding

None.

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.

Supplementary material

535_2019_1619_MOESM1_ESM.tif (416 kb)
Supplementary Figure 1: Cumulative probability of GEV progression after SVR according to their baseline size (a) and the baseline LSM (b). In Supp. Figure 1a, solid line represents patients with baseline LR-GEV, and dashed line represents those without baseline GEV. In Supp. Figure 1b, solid line represents patients with baseline LSM ≥ 25 kPa, and dashed line represents those with baseline LSM <25 kPa. Patients with baseline HR-GEV have been excluded from the model (TIF 417 kb)
535_2019_1619_MOESM2_ESM.tif (405 kb)
Supplementary Figure 2: Cumulative probability of GEV improvement after SVR according to their baseline size (a) and the baseline LSM (b). In Supp. Figure 2a, solid line represents patients with baseline HR-GEV, and dashed line represents those with baseline LR-GEV. In Supp. Figure 2b, solid line represents patients with baseline LSM ≥ 25 kPa, and dashed line represents those with baseline LSM <25 kPa. Patients without GEV at baseline have been excluded from the model (TIF 405 kb)

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Copyright information

© Japanese Society of Gastroenterology 2019

Authors and Affiliations

  • Marc Puigvehí
    • 1
  • María-Carlota Londoño
    • 2
  • Xavier Torras
    • 3
  • Sara Lorente
    • 4
  • Mercedes Vergara
    • 5
  • Rosa Maria Morillas
    • 6
  • Helena Masnou
    • 6
  • Trinidad Serrano
    • 4
  • Mireia Miquel
    • 5
  • Adolfo Gallego
    • 3
  • Sabela Lens
    • 2
  • Jose Antonio Carrión
    • 1
    Email author
  1. 1.Liver Section, Gastroenterology DepartmentHospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Universitat Autònoma de Barcelona (UAB)BarcelonaSpain
  2. 2.Liver Unit, Institut de Malalties Digestives i Metabòliques, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)IDIBAPSBarcelonaSpain
  3. 3.Gastroenterology Department, Hospital de La Santa Creu i Sant PauCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)BarcelonaSpain
  4. 4.Liver Unit, Gastroenterology DepartmentHospital Clínico Lozano BlesaZaragozaSpain
  5. 5.Liver Unit, Digestive Disease Department, Parc Taulí Sabadell Hospital Universitari, Institut D’Investigació i Innovació Parc Taulí I3PTUniversitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)BarcelonaSpain
  6. 6.Hepatology Department, Hospital Germans Trias i PujolCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)BarcelonaSpain

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