Autoimmune Hepatitis During Ledipasvir/Sofosbuvir Treatment of Hepatitis C: A Case Report

Covini, Giovanni; Bredi, Elena; Badalamenti, Salvatore; Roncalli, Massimo; Aghemo, Alessio; Colombo, Massimo

doi:10.1002/hep4.1248

Cited by 11 publications

(1 citation statement)

References 24 publications

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“…Nine (2.6%) patients encountered ALT levels more than 5‐fold the upper limit of normal, and one female had an attack of autoimmune hepatitis. Case reports of autoimmune hepatitis during DAA therapy were published recently, and this disease should be put into the differential diagnosis when meeting liver injury during DAA . Besides, two (22.2%) had late elevation of ALT level after treatment week 8, and both had flares of hepatitis B.…”

Section: Discussionmentioning

confidence: 99%

Real‐world experience of elbasvir/grazoprevir in Taiwan: This study was focused on liver and renal adverse effects

Hsieh

Lin

Hung

et al. 2020

Journal of Viral Hepatitis

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Elbasvir/grazoprevir with or without ribavirin has excellent efficacy and safety for the treatment of hepatitis C virus (HCV) genotype 1 and 4 patients. The real‐world experience has been reported but the detailed analysis of liver and renal adverse effects is lacking. This study evaluated the real‐world experience relating to the effectiveness and liver/renal safety of elbasvir/grazoprevir in HCV genotype 1 patients with compensated liver disease. In the four medical centres of Chang Gung Medical System, 350 HCV genotype 1 patients with compensated liver disease who were treated with elbasvir/grazoprevir were enrolled. Clinical characteristics and laboratory data were collected. The effectiveness (sustained virologic response 12 weeks after end of treatment, SVR12) and safety were assessed. A consecutive series of 350 patients with a mean age of 68.8 ± 10.0 years old were enrolled. The majority were treatment‐naïve (72.3%), genotype 1b (97.7%) and advanced fibrosis/cirrhosis (94.3%). Seventy‐nine (22.6%) had hepatocellular carcinoma and 23 (6.6%) had coinfection with hepatitis B. The effectiveness of SVR12 was 94.6% (95% CI: 92.2%‐97.0%) in the full analysis set and 99.1% (95% CI: 98.1%‐100.1%) in the per‐protocol set. There were two relapses and one nonresponder. Seven (2.0%) patients had adverse events resulting in premature discontinuation of treatment. Five of them were considered drug‐related. One was due to autoimmune hepatitis. Contrary to previous reports, around 49% of ALT elevation was observed after 8 weeks, and in two patients was due to hepatitis B flares. As to the renal function during the course of therapy, a minor deterioration of eGFR was observed in patients with baseline eGFR ≥60 mL/min/1.73 m2, but not in those with baseline eGFR <60, <60‐30 or <30 mL/min/1.73 m2. In this real‐world data, elbasvir/grazoprevir was effective with few liver/renal adverse effects. One patient developed autoimmune hepatitis.

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Section: Discussionmentioning

confidence: 99%