Predictors of treatment efficacy and ALT non-normalization with sofosbuvir/ribavirin therapy for patients with hepatitis C virus genotype 2.
The tolerability and efficacy of sofosbuvir and ribavirin in patients infected with hepatitis C virus (HCV) genotype 2 were investigated under actual clinical conditions. A total of 208 patients with chronic HCV genotype 2 infection were treated with sofosbuvir 400 mg and ribavirin (weight-based dosing) for 12 weeks. Treatment discontinuation and sustained virological response 12 (SVR12) were evaluated. Moreover, factors associated with SVR12, hemoglobin decreasing to less than 10 g/dL during treatment, and alanine aminotransferase (ALT) non-normalization after treatment were evaluated. In all patients, SVR12 responses were 96.1% (200/208). About 6 of 8 patients (3.8%) who did not achieve SVR12 were re-treatment patients, and eight patients who did not achieve SVR all had liver cirrhosis. Multivariate analysis also identified body mass index (OR = 0.79; P < 0.001), platelet count (OR = 0.88; P = 0.003), and estimated glomerular filtration rate (eGFR) (OR = 0.96; P = 0.007) as independent contributing factors associated with hemoglobin decreasing to less than 10 g/dL during treatment, and only Mac-2 Binding Protein Glycosylation isomer (M2BpGi) (OR = 2.46; P = 0.017) as an independent contributing factor associated with ALT non-normalization after treatment. Cirrhotic patients may have a relatively high rate of treatment failure. In patients whose M2BpGi levels are elevated, their ALT tended to not normalize after treatment completion. These patients who did not achieve normalization of ALT after sofosbuvir plus RBV treatment need more careful observation for emergence of hepatocellular carcinoma even after achievement of SVR.
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
Takao
T
Watanabe
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
Yoshio
Y
Tokumoto
Center for Liver-Biliary-Pancreatic Diseases, Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan.
Kouji
K
Joko
Department of Gastroenterology, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan.
Kojiro
K
Michitaka
Department of Gastroenterology, Saiseikai Imabari Hospital, Imabari, Ehime, Japan.
Norio
N
Horiike
Department of Gastroenterology, Matsuyama Shimin Hospital, Matsuyama, Ehime, Japan.
Yoshinori
Y
Tanaka
Department of Internal Medicine, Saiseikai Matsuyama Hospital, Matsuyama, Ehime, Japan.
Fujimasa
F
Tada
Department of Gastroenterology, Uwajima City Hospital, Uwajima, Ehime, Japan.
Yoshiyasu
Y
Kisaka
Department of Gastroenterology, Ehime Prefectural Imabari Hospital, Imabari, Ehime, Japan.
Seiji
S
Nakanishi
Department of Internal Medicine, Ehime Prefectural Niihama Hospital, Niihama, Ehime, Japan.
Takashi
T
Nonaka
Department of Gastroenterology, National Hospital Organization Ehime Medical Center, Toon, Ehime, Japan.
Kazuhiko
K
Yamauchi
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
Masashi
M
Hirooka
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
Masanori
M
Abe
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
Yoichi
Y
Hiasa
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood*; D000951:Antigens, Neoplasm / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage*; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D005838:Genotype; D006454:Hemoglobins / Q000032:analysis; D016174:Hepacivirus / Q000145:classification* / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008562:Membrane Glycoproteins / Q000097:blood; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012254:Ribavirin / Q000008:administration & dosage*; D000069474:Sofosbuvir / Q000008:administration & dosage*; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D028761:Withholding Treatment
D000951:Antigens, Neoplasm; D000998:Antiviral Agents; D006454:Hemoglobins; D008562:Membrane Glycoproteins; C114782:TAA90K protein, human; D012254:Ribavirin; D000410:Alanine Transaminase; D000069474:Sofosbuvir
ALT normalization; HCV genotype 2; carcinogenesis; sofosbuvir