The outcome of combined treatment with ombitasvir-paritaprevir-ritonavir, sofosbuvir with or without ribavirin as salvage therapy for Egyptian HCV experienced patients: A single center study

Abstract

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 intentionto-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.

Current situation of viral hepatitis in Egypt

“…Re‐treatment with PEG‐IFN/SOF in PEG‐IFN/RBV‐experienced patients showed a high probability of treatment failure 117 . In chronic HCV patients who failed an initial SOF‐based regimen, a salvage regimen composed of PrO + SOF/RBV achieved an SVR rate of 93.4% with the intention‐to‐treat and 100% on the per‐protocol analysis 118 …”

Three regimens for re-treatment failure of Sofosbuvir-based therapy for chronic hepatitis-C genotype-4: a cohort study

“…They reported that this was the lowest SVR-12 among their used treatment regimens. Another study by Ismail and Wadea 24 also reported an intention-to-treat SVR-12 of 93.4% 23 . Our study showed a higher SVR-12 for this regimen, up to 99.3% in patients who completed their 12-week treatment regimens and 96.16% in all patients who received it.…”

“…In our study, the response rate to this regimen was 96.2%. So far, the SOF/DCV±RBV combination has proved an adequate efficacy (SVR-12 of 94% in cirrhotic patients and 90.4% in treatment-experienced patients) and safety for the treatment of naïve and experienced Egyptian patients with CHC 24 . El-Khayat et al 25 reported that the addition of RBV significantly increased SVR-12 rates.…”