Ismail Waleed Abdelfattah, Wadea Fady Maher
Internal Medicine Department, Gastroenterology and Hepatology Unit, Faculty of Medicine, Zagazig University.
Drug Discov Ther. 2018;12(6):368-373. doi: 10.5582/ddt.2018.01080.
We aimed to investigate the efficacy and safety of combination of sofosbuvir with ombitasvir, paritaprevir, and ritonavir ± ribavirin as a retreatment option for experienced Egyptian patients who failed previous sofosbuvir, daclatasvir ± ribavirin therapy. A total of 75 treatment-experienced patients were allocated for the completion of their treatment period according to criteria formed by the national committee for control of viral hepatitis. The enrolled patients were followed up throughout treatment, at the end of treatment and 3 months after the end of the treatment by clinical evaluation and laboratory investigations. 27 patients were treated with sofosbuvir with ombitasvir, paritaprevir, and ritonavir plus ribavirin for 12 weeks while 48 patients were treated with sofosbuvir with ombitasvir, paritaprevir, and ritonavir without ribavirin for 24 weeks. The per-protocol sustained virological response at week 12 (SVR12) rate was 100% in both groups while the intention-to-treat SVR12 was 93.4% in all patients, 97.9% in the 24 weeks group and 85.2% in the 12 weeks group. The regimen was well tolerated and the most common adverse effects observed across treatment and during follow-up period included fatigue (38.6%) and headache (29.3%), withdrawal due to adverse effects occurred in 6.6%. We can conclude that retreatment with sofosbuvir with ombitasvir, paritaprevir, and ritonavir ± ribavirin is well tolerated and achieved high SVR12 rates in chronic HCV Egyptian patients with previous sofosbuvir plus daclatasvir treatment failure. Ribavirin free regimen for 24 weeks exerted significant lesser adverse effects.
我们旨在研究索磷布韦与奥比他韦、帕利哌韦和利托那韦联合使用±利巴韦林,作为曾接受过索磷布韦、达拉他韦±利巴韦林治疗但治疗失败的有经验的埃及患者的再治疗方案的疗效和安全性。根据国家病毒性肝炎控制委员会制定的标准,共分配了75名有治疗经验的患者完成其治疗期。对入组患者在整个治疗过程中、治疗结束时以及治疗结束后3个月进行临床评估和实验室检查随访。27名患者接受索磷布韦与奥比他韦、帕利哌韦和利托那韦加利巴韦林治疗12周,而48名患者接受索磷布韦与奥比他韦、帕利哌韦和利托那韦不加利巴韦林治疗24周。两组在第12周的符合方案持续病毒学应答(SVR12)率均为100%,而所有患者的意向性治疗SVR12率为93.4%,24周组为97.9%,12周组为85.2%。该方案耐受性良好,在整个治疗过程和随访期间观察到的最常见不良反应包括疲劳(38.6%)和头痛(29.3%),因不良反应停药的发生率为6.6%。我们可以得出结论,对于既往接受索磷布韦加达拉他韦治疗失败的慢性丙型肝炎埃及患者,使用索磷布韦与奥比他韦、帕利哌韦和利托那韦联合使用±利巴韦林进行再治疗耐受性良好,且SVR12率较高。24周的无利巴韦林方案产生的不良反应明显较少。