Direct-acting antiviral regimens in Egyptian patients with chronic hepatitis C virus infection: A real-world single-center experience.

BACKGROUND AND STUDY AIMS: Chronic hepatitis C virus (HCV) infection has always been identified as a major health threat and a potential cause of liver cirrhosis, portal hypertension, and other associated problems. The introduction of direct-acting antiviral agents (DAAs) has represented a paradigm shift in HCV management. In this study, we aim to observe the rate of sustained virologic response (SVR12) in a large scale of patients at a single center as well as record the post-treatment changes in the hematologic, hepatic, and renal biochemical profiles. PATIENTS AND METHODS: In total, 1933 chronic HCV genotype 4 mono-infected non-HCC patients who completed the treatment with six different DAA regimens in the Faculty of Medicine, Ain Shams University Research Institute (MASRI), were retrospectively enrolled in this study. The rate of sustained virologic response after 12 weeks off-therapy (SVR12) was assessed. The baseline characteristics to predict the SVR12 were then analyzed. The post-treatment changes in many profiles were recorded and analyzed. RESULTS: The overall SVR12 rate was 96.2% (after excluding 84 cases who were lost to follow-up). It was achieved in 346/375 patients (92.3%), 466/477 patients (97.7%), 60/62 patients (96.8%), 11/11 patients (100%), 532/545 patients (97.6%), and 445/463 patients (96.1%) who received sofosbuvir/daclatasvir (SOF/DCV), sofosbuvir/daclatasvir/ribavirin (SOF/DCV/RBV), sofosbuvir/ledipasvir (SOF/LDV), sofosbuvir/ledipasvir/ribavirin (SOF/LDV/RBV), sofosbuvir/simeprevir (SOF/SMV), and ombitasvir/paritaprevir/ritonavir/ribavirin (OBV/PTV/r + RBV), respectively. In total, 73 patients (3.8%) failed to achieve SVR12. The baseline aspartate aminotransferase (AST), cirrhotic status, and treatment regimen were determined to have a significant impact on SVR12. In the overall treated population, the levels of serum AST, alanine aminotransferase, albumin, creatinine, bilirubin, and hemoglobin and platelet count improved significantly after treatment. Furthermore, sustained virologic response was strongly related to cirrhosis and its degree. CONCLUSION: The interferon-free DAA regimens offered high SVR12 rates in Egyptian patients with chronic HCV infection. They were associated with a significant improvement in the hematologic, hepatic, and renal biochemical profiles. The baseline AST, liver cirrhosis, and treatment regimen might have an impact on achieving SVR.

Assessment of facility performance during mass treatment of chronic hepatitis C in Egypt: Enablers and obstacles.

BACKGROUND: The national committee for control of viral hepatitis (NCCVH) in Egypt, settled by the Ministry of health, treated over one million patients in around 60 centers with chronological changes in drug combinations. This research aims to study the health care facilities and services provided by NCCVH treatment centers in Egypt and explore hinders faced. METHODS: A cross-sectional operational research study. Multistage random sampling technique was applied for Egyptian governorates. From each stratum one governorate was chosen from which one center was randomly selected. Quality of recorded data for each center in the central server (Data-oriented parameter), newly designed score to assess the overall performance of the centers was retrieved from computer based recording system. A self-administered questionnaire was completed by the centers head. RESULTS: This study included 24 treatment centers from urban, rural areas, Upper and Lower Egypt. The Upper centers showed the best completeness of follow-up records and the least compliance rates. None of the centers had 100% completeness of follow-up data. Proportion of SVR is minimally less than proportion of patient with known outcome in all treatment centers. A novel indicator standardizing the comparisons of performance of different facilities was introduced: Total number of physicians/total number of SVR patients with completed records. The highest response rate: Monfiya Governorate (Lower Egypt), Aswan (Upper Egypt), Completeness of follow-up records: Kalyoubia (Lower Egypt), Sohag governorate (Upper Egypt). The average administrative score was 64%. CONCLUSION: Challenges of NCCVH program: overcrowdings, resistant sociocultural background among rural patients, limited accessibility for internal migrants and incompleteness of data entry are system lacking points. Strengths include, clear patient pathway, well-established database online application, well-trained physicians and treatment availability.

Serious Adverse Events with Sofosbuvir Combined with Interferon and Ribavirin: Real-Life Egyptian Experience.

Viral hepatitis is a serious problem worldwide that was under-recognized till recently. The prevalence of chronic hepatitis C virus (HCV) is estimated to be 180 million people worldwide. Treatment of chronic HCV using combined pegylated interferon and ribavirin (PEG/RIBA) has long been the standard of care with modest response. In our study, we will report the real-life experience of serious adverse events (SAEs) that were reported by the National Committee for Control of Viral Hepatitis (NCCVH, Cairo, Egypt) program while treating chronic HCV using the triple therapy, sofosbuvir combined with pegylated interferon and ribavirin (PEG/RIBA/SOF), which led to premature discontinuation of treatment. This retrospective analysis included a total of 6,989 chronic HCV patients who were treated by the NCCVH. They received the triple antiviral therapy in 26 treatment centers in Egypt using PEG/RIBA/SOF for 12 weeks. Among 6,989 patients who were treated in 26 treatment centers related to NCCVH, 406 cases (5.9%) reported SAEs and prematurely stopped their treatment. Triple therapy PEG/RIBA/SOF was an important intermediate milestone between interferon-based therapy and the interferon-free all-oral direct acting antiviral agents (DAAs). Results of this study were the leading cause of discontinuation of interferon-based therapy and introduction of interferon-free all-oral treatment protocols, incorporating DAAs from different classes as soon as they gain approval.