中文English
ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Issue 6
Jun.  2017
Turn off MathJax
Article Contents

Adverse effects, drug interactions, and safety of direct-acting antiviral agents in treatment of hepatitis C

DOI: 10.3969/j.issn.1001-5256.2017.06.010
  • Published Date: 2017-06-20
  • In recent years, direct-acting antiviral agents (DAAs) have achieved great success in the treatment of hepatitis C and have replaced interferon/ribavirin. However, since DAAs were launched not long ago, there lacks sufficient knowledge of their toxic and side effects, interactions with other drugs, and safety in patients complicated by other serious chronic diseases. The results of many large-scale clinical trials show that DAAs have good safety in different populations and serious toxic and side effects are rare, but drug interactions need to be taken seriously. The addition of ribavirin in DAA regimen or prolongation of DAA treatment does not increase patients' benefits and may cause more adverse events. Moreover, at the same time of DAA treatment, liver injury caused by HCV cannot be neglected, and continuous treatment should be given.

     

  • loading
  • [1]WANG YY, NIE QH.Current status of research on direct-acting antiviral agents and their application in treatment of chronic hepatitis C[J].Chin Hepatol, 2016, 21 (2) :140-142. (in Chinese) 王媛媛, 聂青和.直接抗病毒药物研究及其治疗慢性丙型肝炎现状[J].肝脏, 2016, 21 (2) :140-142.
    [2]European Association for Study of Liver.EASL recommendations on treatment of hepatitis C 2016[J].J Hepatol, 2017, 66 (1) :153-194.
    [3]WHO Guidelines Approved by the Guidelines Review Committee.In:Guidelines for the screening care and treatment of persons with chronic hepatitis C infection:updated version[Z].Geneva:World Health Organization.Copyright (c) World Health Organization2016.
    [4]PANEL AIHG.Hepatitis C guidance:AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus[J].Hepatology, 2015, 62 (3) :932-954.
    [5]LAWITZ E, MATUSOW G, DEJESUS E, et al.Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis:a phase 3 study (OPTIMIST-2) [J].Hepatology, 2016, 64 (2) :360-369.
    [6]KWO P, GITLIN N, NAHASS R, et al.Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis:OPTIMIST-1, a phase 3, randomized study[J].Hepatology, 2016, 64 (2) :370-380.
    [7]LAWITZ E, SULKOWSKI MS, GHALIB R, et al.Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients:the COSMOS randomised study[J].Lancet, 2014, 384 (9956) :1756-1765.
    [8]ABERGEL A, METIVIER S, SAMUEL D, et al.Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection[J].Hepatology, 2016, 64 (4) :1049-1056.
    [9]ABERGEL A, ASSELAH T, METIVIER S, et al.Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection:an open-label, multicentre, single-arm, phase 2 study[J].Lancet Infect Dis, 2016, 16 (4) :459-464.
    [10]KOHLI A, KAPOOR R, SIMS Z, et al.Ledipasvir and sofosbuvir for hepatitis C genotype 4:a proof-of-concept, single-centre, open-label phase 2a cohort study[J].Lancet Infect Dis, 2015, 15 (9) :1049-1054.
    [11]GANE EJ, HYLAND RH, AN D, et al.Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection[J].Gastroenterology, 2015, 149 (6) :1454-1461.
    [12]BOURLIERE M, BRONOWICKI JP, de LEDINGHEN V, et al.Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy:a randomised, doubleblind, phase 2 trial (SIRIUS) [J].Lancet Infect Dis, 2015, 15 (4) :397-404.
    [13]LAWITZ E, POORDAD FF, PANG PS, et al.Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR) :an open-label, randomised, phase 2 trial[J].Lancet, 2014, 383 (9916) :515-523.
    [14]KOWDLEY KV, GORDON SC, REDDY KR, et al.Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis[J].New Engl J Med, 2014, 370 (20) :1879-1888.
    [15]AFDHAL N, ZEUZEM S, KWO P, et al.Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection[J].New Engl J Med, 2014, 370 (20) :1889-1898.
    [16]AFDHAL N, REDDY KR, NELSON DR, et al.Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection[J].New Engl J Med, 2014, 370 (16) :1483-1493.
    [17]LAWITZ E, MAKARA M, AKARCA US, et al.Efficacy and safety of ombitasvir, paritaprevir, and ritonavir in an open-label study of patients with genotype 1b chronic hepatitis C virus infection with and without cirrhosis[J].Gastroenterology, 2015, 149 (4) :971-980.
    [18]HEZODE C, ASSELAH T, REDDY KR, et al.Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I) :a randomised, open-label trial[J].Lancet, 2015, 385 (9986) :2502-2509.
    [19]FELD JJ, MORENO C, TRINH R, et al.Sustained virologic response of 100%in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks[J].J Hepatol, 2016, 64 (2) :301-307.
    [20]FERENCI P, BERNSTEIN D, LALEZARI J, et al.ABT-450/r–ombitasvir and dasabuvir with or without ribavirin for HCV[J].New Engl J Med, 2014, 370 (21) :1983-1992.
    [21]ANDREONE P, COLOMBO MG, ENEJOSA JV, et al.ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97%and 100%sustained virologic response with or without ribavirin in treatmentexperienced patients with HCV genotype 1b infection[J].Gastroenterology, 2014, 147 (2) :359-365.
    [22]NELSON DR, COOPER JN, LALEZARI JP, et al.All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection:ALLY-3 phase III study[J].Hepatology, 2015, 61 (4) :1127-1135.
    [23]SULKOWSKI MS, GARDINER DF, RODRIGUEZ-TORRES M, et al.Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection[J].New Engl J Med, 2014, 370 (3) :211-221.
    [24]SULKOWSKI M, HEZODE C, GERSTOFT J, et al.Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY) :a randomised, open-label phase 2 trial[J].Lancet, 2015, 385 (9973) :1087-1097.
    [25]LAWITZ E, GANE E, PEARLMAN B, et al.Efficacy and safety of 12weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (CWORTHY) :a randomised, open-label phase 2 trial[J].Lancet, 2015, 385 (9973) :1075-1086.
    [26]FOSTER GR, AFDHAL N, ROBERTS SK, et al.Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection[J].New Engl J Med, 2015, 373 (27) :2608-2617.
    [27]FELD JJ, JACOBSON IM, HZODE C, et al.Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection[J].New Engl J Med, 2015, 373 (27) :2599-2607.
    [28]CURRY MP, O'LEARY JG, BZOWEJ N, et al.Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis[J].New Engl J Med, 2015, 373 (27) :2618-2628.
    [29]DICK TB, LINDBERG LS, RAMIREZ DD, et al.A clinician's guide to drug-drug interactions with direct-acting antiviral agents for the treatment of hepatitis C viral infection[J].Hepatology, 2016, 63 (2) :634-643.
    [30]HERNANDEZ MD, SHERMAN KE.HIV/hepatitis C coinfection natural history and disease progression[J].Curr Opin HIV AIDS, 2011, 6 (6) :478-482.
    [31]KHATRI A, DUTTA S, DUNBAR M, et al.Evaluation of drug-drug interactions between direct-acting anti-hepatitis C virus combination regimens and the HIV-1 antiretroviral agents raltegravir, tenofovir, emtricitabine, efavirenz, and rilpivirine[J].Antimicrob Agents Ch, 2016, 60 (5) :2965-2971.
    [32]POIZOT-MARTIN I, NAQVI A, OBRY-ROGUET V, et al.Potential for drug-drug interactions between antiretrovirals and HCV direct acting antivirals in a large cohort of HIV/HCV coinfected patients[J].PLo S One, 2015, 10 (10) :e141164.
    [33]BADRI PS, DUTTA S, WANG H, et al.Drug interactions with the direct-acting antiviral combination of ombitasvir and paritaprevir-ritonavir[J].Antimicrob Agents Ch, 2016, 60 (1) :105-114.
    [34]RENET S, CHAUMAIS M, ANTONINI T, et al.Extreme bradycardia after first doses of sofosbuvir and daclatasvir in patients receiving amiodarone:2 cases including a rechallenge[J].Gastroenterology, 2015, 149 (6) :1378-1380.
    [35]WYLES DL, RUANE PJ, SULKOWSKI MS, et al.Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1[J].New Engl J Med, 2015, 373 (8) :714-725.
    [36]POCKROS PJ, REDDY KR, MANTRY PS, et al.Efficacy of direct-acting antiviral combination for patients with hepatitis C virus genotype 1 infection and severe renal impairment or end-stage renal disease[J].Gastroenterology, 2016, 150 (7) :1590-1598.
    [37]ROTH D, NELSON DR, BRUCHFELD A, et al.Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study) :a combination phase 3study[J].Lancet, 2015, 386 (10003) :1537-1545.
    [38]SORIANO V, LABARGA P, de MENDOZA C, et al.New hepatitis C therapies for special patient populations[J].Expert Opin Pharmaco, 2016, 17 (2) :217-229.
    [39]UEDA Y, UEMOTO S.Interferon-free therapy for hepatitis C in liver transplant recipients[J].Transplantation, 2016, 100 (1) :54-60.
    [40]SURAWEERA D, SAAB EG, TONG MJ, et al.Timing of hepatitis C antiviral therapy in liver transplant recipients with direct-acting agents[J].Exp Clin Transplant, 2016, 14 (3) :243-251.
    [41]ENDE AR, KIM NH, YEH MM, et al.Fulminant hepatitis B reactivation leading to liver transplantation in a patient with chronic hepatitis C treated with simeprevir and sofosbuvir:a case report[J].J Med Case Rep, 2015, 9 (1) :164.
    [42]COLLINS JM, RAPHAEL KL, TERRY C, et al.Hepatitis B virus reactivation during successful treatment of hepatitis C virus with sofosbuvir and simeprevir[J].Clin Infect Dis, 2015, 61 (8) :1304-1306.
    [43]GANE EJ, SCHWABE C, HYLAND RH, et al.Efficacy of the combination of sofosbuvir, velpatasvir, and the NS3/4A protease inhibitor GS-9857 in treatment-naive or previously treated patients with hepatitis C virus genotype 1 or 3 infections[J].Gastroenterology, 2016, 151 (3) :448-456.
    [44]GANE EJ, KOWDLEY KV, POUND D, et al.Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with hepatitis C virus genotype2, 3, 4, or 6 infections in an open-label, phase 2 trial[J].Gastroenterology, 2016, 151 (5) :902-909.
    [45]ZHU T, NIE QH.New progress in development of animal models of hepatitis C virus infection[J].J Clin Hepatol, 2015, 31 (1) :123-126. (in Chinese) 朱婷, 聂青和.HCV感染动物模型的研究进展[J].临床肝胆病杂志, 2015, 31 (1) :123-126.
    [46]WANG M, NIE QH.Current status of Chinese herbal medicine and active extracts in treatment of hepatitis C[J].Chin Hepatol, 2014, 19 (2) :140-143. (in Chinese) 汪萌, 聂青和.中草药及有效提取物治疗丙型肝炎的现状[J].肝脏, 2014, 19 (2) :140-143.
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Article Metrics

    Article views (3103) PDF downloads(535) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return