Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India; Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF), Punjab Government, Punjab, India; Technical Resource Group - National Viral Hepatitis Control Program (NVHCP), Government of India, India; Injection Safety Project, Punjab Government, Punjab, India.
Hepatitis C Virus Infection State Program, Punjab, India; Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF), Punjab Government, Punjab, India.
J Hepatol. 2019 Dec;71(6):1076-1085. doi: 10.1016/j.jhep.2019.07.006. Epub 2019 Jul 17.
BACKGROUND & AIMS: The prevalence of anti-hepatitis C virus antibody in Punjab, India is 3.6%, with 728,000 people estimated to have viremic chronic hepatitis C (CHC). The Mukh-Mantri Punjab Hepatitis C Relief Fund, launched on 18th June 2016, provides no-cost generic direct-acting antivirals (DAAs) with sofosbuvir + ledipasvir ± ribavirin or sofosbuvir + daclatasvir ± ribavirin with the goal of eliminating CHC from Punjab. We assessed the safety and efficacy of decentralized treatment of CHC in a public health care setting.
Primary care providers from 3 university and 22 district hospitals were trained to provide algorithm-based DAA treatment and supervised by telehealth clinics conducted fortnightly. The diagnosis of cirrhosis was based on clinical and radiological evidence, including aspartate aminotransferase-to-platelet ratio index (APRI ≥2.0) and FIB-4 score (>3.25), or on liver stiffness measurement ≥12.5 kPa on Fibroscan®.
We enrolled 48,088 individuals with CHC (63.8% male; mean age 42.1 years; 80.5% rural; 14.8% compensated cirrhosis; 69.9% genotype [GT] 3) between 18th June 2016 to 31st July 2018. While 36,250 (75.4%) patients completed treatment, 5,497 (11.4%) had treatment interruptions and 6,341 (13.2%) patients are currently ongoing treatment. Sustained virological response at 12 weeks after treatment completion (SVR12) was achieved in 91.6% of patients per protocol, 67.6% in intention-to-treat (ITT) analysis, where all interruptions were treated as failures, and 91.2% in a modified ITT analysis where all patients with successful SVR12 in the interruptions arm were included as cured. SVR12 rates in patients with and without cirrhosis and GT3 versus non-GT3 were comparable. The SVR12 rate was 84.4% in patients who had treatment interruptions.
Decentralized care of patients with CHC using generic all-oral DAA regimens is safe and effective regardless of genotype or presence of cirrhosis. ClinicalTrials.gov number: NCT01110447.
We assessed the safety and efficacy of public health care using no-cost all-oral generic direct-acting antiviral drugs against hepatitis C in the state of Punjab, India. The goal is elimination of chronic hepatitis C (CHC) by 2030 and involves primary care providers at 25 sites in the state. We enrolled 48,088 individuals (63.8% male; mean age 42.1 years; 80.5% rural; 14.8% compensated cirrhotic; 69.9% genotype 3) between 18th June 2016 to 31st July 2018. Cure was achieved in 91.6% of patients, demonstrating that decentralized care of CHC with generic all-oral regimens is safe and effective.
印度旁遮普邦抗丙型肝炎病毒抗体的流行率为 3.6%，估计有 72.8 万人患有病毒血症慢性丙型肝炎（CHC）。2016 年 6 月 18 日启动的 Mukh-Mantri Punjab Hepatitis C Relief Fund 提供免费的通用直接作用抗病毒药物（DAAs），包括索非布韦+雷迪帕韦±利巴韦林或索非布韦+达拉他韦±利巴韦林，目标是消除旁遮普邦的 CHC。我们评估了在公共卫生保健环境中分散治疗 CHC 的安全性和疗效。
来自 3 所大学和 22 所地区医院的初级保健提供者接受了基于算法的 DAA 治疗培训，并由每两周进行一次的远程医疗诊所进行监督。肝硬化的诊断基于临床和影像学证据，包括天冬氨酸氨基转移酶-血小板比值指数（APRI≥2.0）和 FIB-4 评分（>3.25），或通过 Fibroscan®检测肝硬度值≥12.5kPa。
我们于 2016 年 6 月 18 日至 2018 年 7 月 31 日期间招募了 48088 名 CHC 患者（63.8%为男性；平均年龄 42.1 岁；80.5%为农村；14.8%为代偿性肝硬化；69.9%为基因型[GT]3）。虽然 36250 名（75.4%）患者完成了治疗，但 5497 名（11.4%）患者出现了治疗中断，6341 名（13.2%）患者目前正在接受治疗。根据方案，治疗完成后 12 周的持续病毒学应答（SVR12）在 91.6%的患者中达到，意向治疗（ITT）分析中为 67.6%，其中所有中断均被视为失败，在修改后的 ITT 分析中，所有中断组中 SVR12 成功的患者均被视为治愈，SVR12 率为 91.2%。有和没有肝硬化以及 GT3 与非 GT3 的患者的 SVR12 率相当。中断治疗的患者的 SVR12 率为 84.4%。
使用通用全口服 DAA 方案在旁遮普邦进行 CHC 患者的分散护理是安全有效的，无论基因型或是否存在肝硬化。临床试验编号：NCT01110447。
我们评估了印度旁遮普邦使用免费的全口服通用直接作用抗病毒药物治疗丙型肝炎的公共卫生保健的安全性和疗效。目标是到 2030 年消除慢性丙型肝炎（CHC），并涉及该州 25 个地点的初级保健提供者。我们于 2016 年 6 月 18 日至 2018 年 7 月 31 日期间招募了 48088 名（63.8%为男性；平均年龄 42.1 岁；80.5%为农村；14.8%为代偿性肝硬化；69.9%为基因型 3）CHC 患者。91.6%的患者达到了治愈，证明了使用通用全口服方案对 CHC 的分散护理是安全有效的。
