Younas Sonia, Mukhtar Hamid, Gohar Umar Farooq, Alsrhani Abdullah, Alzahrani Badr, Junaid Kashaf, Qamar Muhammad Usman, Ejaz Hasan
HKU-Pasteur Research Pole, School of Public Health, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Institute of Industrial Biotechnology, Government College University Lahore, Lahore, Pakistan.
J Infect Dev Ctries. 2021 Oct 31;15(10):1489-1496. doi: 10.3855/jidc.12912.
The conventional interferon therapy of hepatitis C virus has been substituted substantially with sofosbuvir and daclatasvir due to constraints in efficacy and tolerability. This study aimed diagnostically to monitor the effectiveness and side effects of direct-acting antivirals in the management of HCV infections.
This prospective study was conducted on HCV-infected patients treated with sofosbuvir and daclatasvir. Different serological, biochemical, hematological, and molecular techniques were used for the assessment of patients. Only treatment-naive patients aged ≥ 18 to 75 years received 12 weeks of treatment. The primary endpoint was a sustained virologic response with undetectable HCV RNA in the patients' serum at the end of the treatment.
We identified 229 cases of confirmed HCV infections by PCR, 94.3% of which had genotype 3. The study population comprised 66% females and 34% males with a median age of 42.2 ± 10.6 SD. Ninety-three percent of the patients accomplished SVR at week 12. The combined therapy of SOF/DAC achieved the highest efficacy rate (92.6%) among the different HCV genotype 3 patients. A statistically significant relationship was observed between low baseline viral load (p < 0.001; 95% CI = 1.2-3.1) and HCV genotype 3 with minor side effects, including lethargy, headache, nausea, insomnia, diarrhea, and fever.
HCV-infected patients can be treated well with an interferon-free SOF/DAC regimen, tolerated with generally mild adverse effects with a higher SVR.
由于疗效和耐受性方面的限制，丙型肝炎病毒的传统干扰素疗法已基本上被索磷布韦和达卡他韦所取代。本研究旨在通过诊断监测直接作用抗病毒药物在丙型肝炎病毒感染管理中的有效性和副作用。
本前瞻性研究针对接受索磷布韦和达卡他韦治疗的丙型肝炎病毒感染患者进行。采用不同的血清学、生化、血液学和分子技术对患者进行评估。仅年龄≥18至75岁且未接受过治疗的患者接受12周的治疗。主要终点是治疗结束时患者血清中丙型肝炎病毒核糖核酸检测不到的持续病毒学应答。
我们通过聚合酶链反应确认了229例丙型肝炎病毒感染病例，其中94.3%为3型基因型。研究人群包括66%的女性和34%的男性，中位年龄为42.2±10.6标准差。93%的患者在第12周实现了持续病毒学应答。在不同的3型丙型肝炎病毒基因型患者中，索磷布韦/达卡他韦联合疗法的有效率最高（92.6%）。在低基线病毒载量（p<0.001；95%置信区间=1.2 - 3.1）与3型丙型肝炎病毒之间观察到具有统计学意义的关系，副作用较小，包括嗜睡、头痛、恶心、失眠、腹泻和发热。
丙型肝炎病毒感染患者可以通过无干扰素的索磷布韦/达卡他韦方案得到良好治疗，耐受性普遍良好，副作用轻微，持续病毒学应答率较高。
