Yoon Jae Hyun, Kim Sun Min, Kang Gaeun, Kim Hee Joon, Jun Chung Hwan, Choi Sung Kyu
Department of Gastroenterology and Hepatology.
Department of Clinical Pharmacology.
Medicine (Baltimore). 2019 Sep;98(39):e17343. doi: 10.1097/MD.0000000000017343.
Glecaprevir/pibrentasvir, a pan-genotypic and ribavirin-free direct acting antiviral agent regimen, has shown significant efficacy and very few serious complications. However, as the drug metabolizes in the liver, it is not recommended in patients with decompensated liver cirrhosis. Herein, we report the case of a patient with compensated liver cirrhosis who developed severe jaundice after glecaprevir/pibrentasvir medication.
A 77-year-old man diagnosed with chronic hepatitis C-related compensated liver cirrhosis visited hospital due to severe jaundice after 12 weeks of glecaprevir/pibrentasvir medication.
On the laboratory work-up, the total/direct bilirubin level was markedly elevated to 21.56/11.68 from 1.81 mg/dL; the alanine aminotransferase and aspartate aminotransferase levels were within the normal range. We checked the plasma drug concentration level of glecaprevir, and 18,500 ng/mL was detected, which was more than 15 times higher than the drug concentration level verified in normal healthy adults.
Glecaprevir/pibrentasvir was abruptly stopped and after 6 days, the drug concentration level decreased to 35 ng/mL and the serum total/direct bilirubin decreased to 7.49/4.06 mg/dL.
Three months after drug cessation, the serum total bilirubin level normalized to 1.21 mg/dL and HCV RNA was not detected.
We report what is likely the first known case of severe jaundice after medication with glecaprevir/pibrentasvir in a patient with compensated liver cirrhosis. Clinicians should bear potential hyperbilirubinemia in mind when treating chronic hepatitis C with this regimen and should monitor the patient closely during follow-up laboratory exams, especially in elderly cirrhotic patients.
格卡瑞韦/哌柏西普,一种泛基因型且不含利巴韦林的直接抗病毒药物方案,已显示出显著疗效且严重并发症极少。然而,由于该药物在肝脏中代谢,不建议用于失代偿期肝硬化患者。在此,我们报告一例代偿期肝硬化患者在服用格卡瑞韦/哌柏西普后出现严重黄疸的病例。
一名77岁男性,诊断为慢性丙型肝炎相关代偿期肝硬化,在服用格卡瑞韦/哌柏西普12周后因严重黄疸入院。
实验室检查显示,总胆红素/直接胆红素水平从1.81mg/dL显著升高至21.56/11.68;丙氨酸氨基转移酶和天冬氨酸氨基转移酶水平在正常范围内。我们检测了格卡瑞韦的血浆药物浓度水平,检测到18500ng/mL,比正常健康成年人验证的药物浓度水平高出15倍以上。
立即停用格卡瑞韦/哌柏西普,6天后,药物浓度水平降至35ng/mL,血清总胆红素/直接胆红素降至7.49/4.06mg/dL。
停药3个月后,血清总胆红素水平恢复正常至1.21mg/dL,未检测到HCV RNA。
我们报告了可能是首例代偿期肝硬化患者服用格卡瑞韦/哌柏西普后出现严重黄疸的病例。临床医生在使用该方案治疗慢性丙型肝炎时应牢记潜在的高胆红素血症,并在后续实验室检查中密切监测患者,尤其是老年肝硬化患者。