الفهرس 
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Abstract
Egyptians have a high prevalence of HCV genotype 4, a poor response to antiviral therapy and an increased risk for the development of liver complications. Infection with HCV is self-limited in a fortunate minority, whereas most patients (60–80%) develop persistent (chronic) infection, which may progress to cirrhosis and hepatocellular carcinoma. chronic kidney disease always impacts negatively on the treatment of chronic hepatitis because of poor drug tolerance, a higher prevalence of side-effects, and the complexities of adapting drug dosages
Management of HCV-positive ESRD patients is complicated. There are unknowns related to prevention of HCV spread in dialysis units, anti-viral therapy in dialysis patients. With the advent of directly acting antiviral (DAA) therapy for hepatitis C virus (HCV), there has been a great increase in the number of patients who can expect to achieve sustained virological response (SVR).
Despite high treatment response rates, no protective immunity is built, so patients that are cured at the end of therapy can be infected with a new HCV strain and might be still at risk to develop liver diseases and relapse can occur. Risk factors for virologic failure or relapse after primary response to DAAs are not well established in most guidelines.
The aim of the current study was to evaluate the possible risk factors for relapse after primary response to direct acting antiviral agents and to evaluate the efficacy of different combination as a treatment for HCV relapse among hemodialysis patients. To achieve this aim, we conducted this study on 250 HCV hemodialysis patients and were divided into 2 groups: study group included 186 relapse patients; Control group included age and sex matched 64 no relapse patients.
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The study included 250 HCV infected hemodialysis patients who were maintained on hemodialysis for mean duration 6.36±1.3 years. Mean age of the included patients was 52.66± 11.57 years and 40% of them were males and 60% were females. About 21.6% of the patients were hypertensive, 18.4% were diabetic, and 2.8% were ischemic heart disease.
Seven patients had clinically diagnosed ascites, 4 patients had history of hematemesis and melena. Liver sonographic appearance was normal in 46.8% of the patients and the remaining was either had enlarged liver (40.4%) or cirrhotic liver (12.8%). Hepatocellular carcinoma was shown in 10 patients (4%). Spleen sonographic appearance was normal in 50.4% of the patients and splenomegaly was diagnosed in 49.6% of the patients.
from the results of the current study, we could conclude the following:
- Four direct acting antiviral regimens were used. Sofosbuvir- based regimen was used in 152 patients and ritonavir boosted
ombitasvir/ paritaprevir was used in 91 patients
- There was significant improvement of serum albumin, ALT, AST and platelets after treatment and there was significant DROP of hemoglobin also.
- There was no significant effect on INR and white blood cells. There was statistically significant decrease in HCV PCR levels. Alfa fetoprotein was assessed once before treatment initiation, and it was equal to 11.13 (0, 18.96) ng/dL.
- No drug related complication was shown in 61.6% of the included patients. The most common adverse event was anemia (25.2%). Other reported adverse events were fatigue, headache, and hepatic decompensation had less than 10% incidence rate. Treatment was
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suspended in 15 patients due to either hemoglobin DROP with ribavirin, INF (11 patients) or non- adherence (4 patients).
- The study included 186 relapse patients. Out of them, 51 patients received SOF/DAC regimen without RBV and 99 patients received SOF/DAC with RBV, 29 patients received ritonavir boosted ombitasvir/ paritaprevir with RBV.
- All patients had achieved rapid virologic response. 12-SVR was achieved in 44 patients (23.66%) as 142 showed relapse within 3 months after treatment completion. The 44 patients showed relapse later and none achieved 24-SVR.
- Relapse and no relapse groups were compared to evaluate risk factors for relapse.
- Univariate analysis revealed that risk factors for relapse included: Enlarged or cirrhotic liver by ultrasound, hepatocellular carcinoma, Sofosbuvir- based regimens, baseline albumin, ALT, AST, bilirubin, hemoglobin and alfa feto-protein, absence of drug related complications as anemia and fatigue.
- All significant risk factors for relapse in the previous univariate analysis were entered in 5 steps multivariate analysis using logistic regression and the regression had statistically significance. Out of different significant risk factors in univariate analysis, cirrhotic liver by ultrasonography, presence of hepatocellular carcinoma, sofosbuvir-based regimen, baseline alfa fetoprotein and high HCV RNA viral load showed statistically significance as risk factors for relapse in the multivariate analysis.
- Other variable could not be considered as risk factors for relapse.
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- All relapse patients were re-treated using one of 2 regimens: Sofosbuvir+ Daclatasvir+ Ribavirin in 23 patients (12.4%) or Sofosbuvir+ Ritonavir/ Ombitasvir/ Paritaprevir+ Ribavirin in 163 patients (87.9%). After treatment, all patients achieved RVR, 12 and 24- SVR
- There was statistically significant between pre and post treatment regarding albumin, AST, bilirubin. There was no statistically significant difference between pre and post treatment regarding ALT, hemoglobin, white blood cells and platelet count.