Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over

• 作者: Akira Kawashima Hideyuki Tamai Hiroyoshi Matsutani Izumi Nishikawa Junpei Okamura Katsuhiko Higashi Naoki Shingaki Ryo Shimizu Shuya Maeshima Taisei Nakao Takeshi Hara Yoshiyuki Ida
• 来源期刊: 世界肝病学杂志:英文版(电子版)
• 学科: 医学
• 关键词: Hepatitis C virus Genotype 2 Sofosbuvir RIBAVIRIN Elderly patients CIRRHOSIS
• 年，卷（期）: 2020,（9）
• 页码范围: 672-684
• 页数: 13页
• 分类号: R73

摘要

BACKGROUND Although clinical use of sofosbuvir plus ribavirin has been approved for patients infected with genotype 2 hepatitis C virus,patients≥75-years-old have not been included in previous clinical trials.AIM To evaluate the real-world safety and efficacy of sofosbuvir plus ribavirin for elderly patients(≥75-years-old)compared to nonelderly patients,we conducted a post-marketing prospective cohort study.METHODS We treated 265 patients with genotype 2 hepatitis C virus using standard approved doses of sofosbuvir(400 mg/d)plus ribavirin adjusted by body weight,administered orally for 12 wk.RESULTS Sustained virological response rates for the overall cohort,patients<65-years-old,≥65-years-old but<75-years-old,and≥75-years-old were 97%(258/265),98%(93/95),97%(84/87),and 98%(81/83),respectively(P=0.842).Logistic regression analyses identified history of hepatocellular carcinoma treatment and alpha-fetoprotein as factors significantly associated with sustained virological response.Alpha-fetoprotein was the only independent factor identified.Sustained virological response rate was significantly lower for patients with hepatocellular carcinoma treatment(91%)than for patients without history of hepatocellular carcinoma treatment(98%,P=0.004).One patient(0.4%)discontinued treatment due to drug-induced pneumonia.Dose reduction or interruption of ribavirin was required for 12.1%(32/265)of patients because of anemia,including 7.7%(14/182)of patients<75-years-old and 21.7%(18/83)of patients≥75-years-old(P=0.002).CONCLUSION Although ribavirin dose reduction or interruption was required with advanced age,sofosbuvir plus ribavirin appears tolerable and highly effective even in patients≥75-years-old.