Personalized Therapy of Chronic Hepatitis C and B Dually Infected Patients With Pegylated Interferon Plus Ribavirin: A Randomized Study.
We aimed to investigate whether response-guided therapy (RGT) with peginterferon-alpha plus ribavirin by using hepatitis C virus (HCV) genotype, pretreatment HCV RNA levels, and rapid virological response (RVR, undetectable HCV RNA at treatment week 4) could be applied for active HCV/hepatitis B virus (HBV) dually infected patients, without compromised the treatment efficacy.A total of 203 patients, seropositive of HCV antibody, HCV RNA and HBV surface antigen (HBsAg), and seronegative for HBV e antigen for >6 months, were randomized to receive peginterferon-alpha/ribavirin by either genotype-guided therapy (GGT, n = 102: HCV genotype 1 [HCV-1], 48 weeks; HCV-2/3, 24 weeks) or RGT (n = 101: HCV-1, 48 or 24 weeks if patients with baseline VL <400,000 IU/mL and RVR; HCV-2/3, 24 or 16 weeks if patients with RVR). The primary endpoint was HCV-sustained virological response (SVR).The HCV SVR rate was comparable between the GGT (77.5%, 79/102) and RGT groups (70.3%, 71/101, P = 0.267), either among HCV-1/HBV (69.4% [43/62] vs 63.5% [40/63], P = 0.571) or among HCV-2/3/HBV (90.0% [36/40] vs 81.6% [31/38], P = 0.342) dually infected patients based on intention-to-treat analysis. In HCV-1/HBV dually infected patients, RVR (odds ratio [OR]: 6.05; 95% confidence intervals [CI]: 2.148-17.025, P = 0.001) and lower pretreatment blood glucose levels (OR: 0.97; CI: 0.944-0.989, P = 0.003) were independent predictors of HCV SVR. Although RVR (OR: 10.68; CI: 1.948-58.514, P = 0.006) was the only significant factor associated with HCV SVR in HCV-2/3/HBV dually infected patients. HBsAg loss at 1 year posttreatment was observed in 17 of 185 (9.2%) patients. The rates of discontinuation and adverse events were similar between the 2 groups.RGT with peginterferon-alpha/RBV may be considered for HBeAg-negative HBV/HCV dually infected patients.
From the Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital (M-LYeh, M-YH, C-FH, P-CL, Y-HL, Z-YL, S-CC, J-FH, C-YD, W-LC, M-LYu), Faculty of Internal Medicine, College of Medicine, and Graduate Institute of Clinical Medicine, and Center for Infectious Disease and Cancer Research, Kaohsiung Medical University (M-LYeh, C-FH, M-HH, Z-YL, S-CC, J-FH, C-YD, W-LC; M-LYu), Institute of Biomedical Sciences, National Sun Yat-Sen University (M-LYu), Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital (C-IH, N-JH), Department of Occupational Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University (C-FH), Department of Preventive Medicine, Kaohsiung Medical University Hospital (M-HH), Graduate Institute of Medicine, College of Medicine (M-LYeh, C-YD), Center for Infectious Disease and Cancer Research; and Center for Lipid Science and Aging Research, Kaohsiung Medical University, Kaohsiung, Taiwan (C-YD, W-LC, M-LYu).
Ming-Lun
ML
Yeh
Ming-Yen
MY
Hsieh
Ching-I
CI
Huang
Chung-Feng
CF
Huang
Meng-Hsuan
MH
Hsieh
Po-Cheng
PC
Liang
Yi-Hung
YH
Lin
Nai-Jen
NJ
Hou
Zu-Yau
ZY
Lin
Shinn-Cherng
SC
Chen
Jee-Fu
JF
Huang
Chia-Yen
CY
Dai
Wan-Long
WL
Chuang
Ming-Lung
ML
Yu
D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D057285:Precision Medicine; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage*
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b