PDF(Pubmed)
Abstract：
Access to Hepatis C treatment in Sub-Saharan Africa is a clinical, public health and ethical concern. The multi-country open-label trial TAC ANRS 12311 allowed assessing the feasibility, safety, efficacy of a specific care model of HCV treatment and retreatment in patients with hepatitis C in Sub Saharan Africa. Between November 2015 and March 2017, with follow-up until mid 2019, treatment-naïve patients with HCV without decompensated cirrhosis or liver cancer were recruited to receive 12 week-treatment with either sofosbuvir + ribavirin (HCV genotype 2) or sofosbuvir + ledipasvir (genotype 1 or 4) and retreatment with sofosbuvir + velpatasvir + voxilaprevir in case of virological failure. The primary outcome was sustained virological response at 12 weeks after end of treatment (SVR12). Secondary outcomes included treatment adherence, safety and SVR12 in patients who were retreated due to non-response to first-line treatment. The model of care relied on both viral load assessment and educational sessions to increase patient awareness, adherence and health literacy. The study recruited 120 participants, 36 HIV-co-infected, and 14 cirrhotic. Only one patient discontinued treatment because of return to home country. Neither death nor severe adverse event occurred. SVR12 was reached in 107 patients (89%): (90%) in genotype 1 or 2, and 88% in GT-4. All retreated patients (n = 13) reached SVR12. HCV treatment is highly acceptable, safe and effective under this model of care. Implementation research is now needed to scale up point-of-care HCV testing and SVR assessment, along with community involvement in patient education, to achieve HCV elimination in Sub-Saharan Africa.
摘要：
在撒哈拉以南非洲获得HepatisC治疗是一种临床，公共卫生和伦理关注。多国开放标签试验TACANRS12311允许评估可行性，安全,在撒哈拉以南非洲丙型肝炎患者中，HCV治疗和再治疗的特定护理模式的有效性。在2015年11月至2017年3月之间，随访至2019年中期，招募了没有失代偿性肝硬化或肝癌的HCV初治患者，接受索非布韦+利巴韦林（HCV基因型2）或索非布韦+ledipasvir（基因型1或4）的12周治疗，并在病毒学衰竭的情况下使用sofosbuvirvelpatasvir+ilapxapre主要结果是治疗结束后12周的持续病毒学应答（SVR12）。次要结果包括治疗依从性，安全性和SVR12在因一线治疗无反应而复治的患者中.护理模式依赖于病毒载量评估和教育会议，以提高患者的意识，坚持和健康素养。这项研究招募了120名参与者，36艾滋病毒共同感染，和14例肝硬化。只有一名患者因返回祖国而停止治疗。未发生死亡或严重不良事件。107例患者（89％）达到SVR12：基因型1或2（90％），GT-4为88％。所有重新治疗的患者（n=13）达到SVR12。HCV治疗是高度可接受的，在这种护理模式下安全有效。现在需要进行实施研究，以扩大现场护理HCV检测和SVR评估，随着社区参与患者教育，在撒哈拉以南非洲实现HCV消除。
