Sood Ajit, Midha Vandana, Goyal Omesh, Hissar Syed, Sharma Suresh Kumar, Khanna Pankaj
Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India,
Indian J Gastroenterol. 2014 Jul;33(4):343-9. doi: 10.1007/s12664-014-0451-5. Epub 2014 Mar 12.
PURPOSE/AIM: Results of treatment of chronic hepatitis C (CHC) with pegylated interferon plus ribavirin (PEG-RBV) are mainly available from well-designed clinical trials, and only few 'real-life' studies which give a true picture of success of therapy are available. Such data in Indian patients is scarce. This prospective study aimed to evaluate the efficacy, safety, and factors associated with sustained virological response (SVR) in Indian CHC patients treated with PEG-RBV in 'real-life' setting.
All treatment-naïve patients with CHC/compensated cirrhosis treated with PEG-RBV between January 2004 and December 2010 were included.
Of 592 patients started on treatment, 524 (88.5 %) completed therapy (mean ± SD age-42.0 ± 12.1 years; 74.3 % males). Genotype 3 (73.6 %) was the commonest, followed by genotype 1 (19.3 %). In intention to treat analysis, SVR rates for 'all' patients, genotype 1 and genotype 3 patients were 72.3 % (428/592), 57 % (65/114), and 78.2 % (341/436), respectively (in per-protocol analysis-81.7 %, 69.1 %, and 85.3 %, respectively). Noncirrhotics had better SVR rates compared to cirrhotics treated for the same duration. About 20 % patients had both low viral load and achieved rapid virological response (RVR). Factors significantly associated with SVR were age <40 years, absence of cirrhosis, RVR, and no reduction in interferon dose.
SVR rates in CHC patients treated in 'real-life' setting in India were better than those reported in western population. Therapy should be prolonged for patients with cirrhosis, while one-fifth of patients may qualify for abbreviated therapy. Factors significantly associated with SVR were age <40 years, absence of cirrhosis, RVR, and no reduction in interferon dose.
目的/目标：聚乙二醇干扰素联合利巴韦林（PEG-RBV）治疗慢性丙型肝炎（CHC）的结果主要来自精心设计的临床试验，而能真实反映治疗成功率的“真实世界”研究却很少。印度患者的此类数据稀缺。这项前瞻性研究旨在评估在“真实世界”环境中接受PEG-RBV治疗的印度CHC患者的疗效、安全性以及与持续病毒学应答（SVR）相关的因素。
纳入2004年1月至2010年12月期间所有初治的CHC/代偿期肝硬化且接受PEG-RBV治疗的患者。
开始治疗的592例患者中，524例（88.5%）完成治疗（平均±标准差年龄-42.0±12.1岁；74.3%为男性）。基因分型3型（73.6%）最为常见，其次是基因分型1型（19.3%）。在意向性分析中，“所有”患者、基因分型1型和基因分型3型患者的SVR率分别为72.3%（428/592）、57%（65/114）和78.2%（341/436）（符合方案分析中分别为81.7%、69.1%和85.3%）。与相同治疗时长的肝硬化患者相比，非肝硬化患者的SVR率更高。约20%的患者病毒载量低且实现了快速病毒学应答（RVR）。与SVR显著相关的因素为年龄<40岁、无肝硬化、RVR以及未降低干扰素剂量。
在印度“真实世界”环境中接受治疗的CHC患者的SVR率高于西方人群报道的SVR率。对于肝硬化患者，治疗应延长，而五分之一的患者可能符合缩短疗程的治疗条件。与SVR显著相关的因素为年龄<40岁、无肝硬化、RVR以及未降低干扰素剂量。
