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RESEARCH PRODUCT

Add-On Peginterferon Alfa-2a Significantly Reduces HBsAg Levels in HBeAg-Negative, Genotype D Chronic Hepatitis B Patients Fully Suppressed on Nucleot(s)ide Analogues Treatment: Final Results of the Hermes Study

Pietro LamperticoA. RozziAntonio CraxìMaurizia Rossana BrunettoMario RizzettoG.b. GaetaMaria Chiara Colombo

subject

0301 basic medicinemedicine.medical_specialtyHBsAgCirrhosisAnemiaGastroenterology03 medical and health scienceschemistry.chemical_compound0302 clinical medicineInternal medicineAscitesmedicineHepatic encephalopathyHepatologybusiness.industryRibavirinmedicine.disease030104 developmental biologychemistryImmunology030211 gastroenterology & hepatologyLiver functionmedicine.symptombusinessPeginterferon alfa-2amedicine.drug

description

23 (36%) cases, respectively. Ribavirin (RBV) was used in 35% and 65% of the patients receiving SOF and DCV, respectively. Most of the patients were male (72%) and genotype 1b (81%). Median age was 59 years. Median baseline MELD and Child–Pugh (CPT) scores were 9 and 6, respectively. Among the patients with cirrhosis, 47% were CPT B/C. Tacrolimus was the immunosuppressant used in the majority of the patients (69%). At the beginning of therapy, 20 patients had ascites and 3 had hepatic encephalopathy (HE). Thirty-four patients completed the treatment course and 30 are still on therapy. End of treatment (EOT) response was 88% (30/34) and SVR12 was 83% (25/30). In patients receiving SMV+DCV±RBV, EOT response was 78% (14/18) due to 4 breakthroughs and SVR4 was 72% (13/18) due to an additional relapse by post-treatment week 4. Four of the non-responder patients had cirrhosis and 3 did not receive RBV. In patients receiving SMV+SOF±RBV, EOT (16/16) and SVR12 (12/12) were 100%. At post-treatment week 12 there was a significant improvement in liver function (Table 1). More importantly, ascites and HE resolved in 15 and 2 patients, respectively. SAEs were reported in 11 patients (anemia [n =2], infections [n = 5], gastrointestinal bleeding [n =1], renal dysfunction [n =1], gastric cancer [n = 1] not considered to be related to SMV). One patient presented eosinophilia considered as possibly related to therapy. Rejection or IS-related toxicity were not reported. No major adjustment in IS drugs were needed. None of the patients died or discontinued therapy due to adverse events.

https://doi.org/10.1016/s0168-8278(16)00198-7