Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease.

BACKGROUND: Till now, pooled data about the safety and efficacy of different direct-acting antiviral (DAAs) regimens in different renal situations are still under evaluation. AIM: To evaluate a real-life experience of the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus ribavirin (OBV/PTV/r plus RIB) in patients with end-stage kidney disease (ESKD). PATIENTS AND METHODS: Between January 2017 and January 2018, an open-label multicenter prospective study was designed to enroll all consecutive patients with proven CHC genotype 4 infections and concomitant ESKD based on estimated glomerular filtration rate (eGFR) with (HD group) or without hemodialysis (non-HD group). Patients were given a co-formula of OBV/PTV/r (25/150/100 mg) once-daily plus RIB was given for 12 weeks. Sustained virologic response (SVR 12) was the primary endpoint. RESULTS: A total of 110 patients were enrolled. An overall SVR 12 was reported in 104 (94.5%) patients, and treatment failure were reported in 6 patients [2 patients (1.8%) were relapsed, and 4 patients (3.6%) patients were non-responders]. SVR12 was 96% in HD and 91.4% in non-HD patients (P = 0.286). There were no reported serious adverse events. Anemia was reported in 66.6% (n = 50) in HD group and in 31.4% (n = 11) in non-HD group. CONCLUSION: Although it is still challenging, achievement of SVR12 in patients with chronic HCV and concomitant end-stage kidney disease in the era of DAAs became possible with a 12 weeks course of a co-formula of ombitasvir/paritaprevir /ritonavir plus ribavirin. CLINICALTRIALS. GOV ID: NCT03341988.

Cryptosporidium infection in chronic kidney disease patients undergoing hemodialysis in Egypt.

Patients with chronic renal failure are more susceptible to infections due to acquired immunodeficiency caused by uremia. Parasitic infections are one of the significant causes of morbidity and mortality in those patients, So we aimed to assess the prevalence of Cryptosporidium spp. and other protozoan infections in patients undergoing hemodialysis in Qena Governorate, Upper Egypt. The present study took place in Qena University Hospitals, Egypt. Participants were 150 Chronic Kidney Disease (CKD) patients undergoing hemodialysis, and 50 healthy individuals. After questionnaire, three consecutive stool samples from each participant were examined macroscopically and microscopically by different techniques for the presence of different stages of different protozoa. 66% of CKD patients and 26% of the control group were infected with intestinal protozoa. Cryptosporidium spp. were the protozoa with the highest prevalence in cases (40%) and control (6%) with statistical significance (P < 0.05). It was detected only in watery stool samples (P value < 0.05). Residence, age and gender were not significant variables in the prevalence of infection among patients with CKD. In Egypt, few studies had reported the prevalence of Cryptosporidiosis in chronic renal patients. Cryptosporidium infection should be suspected in all cases of prolonged watery diarrhea in CKD patients and stool samples should be examined using special stains as cold modified Ziehl-Neelsen staining for proper diagnosis of Cryptosporidium infections.

Sofosbuvir-daclatasvir improves hepatitis C virus-induced mixed cryoglobulinemia: Upper Egypt experience.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) infection is associated with extrahepatic manifestations such as cryoglobulinemia and accounts for up to 90% of all cases of mixed cryoglobulinemia (MC). The present study aimed to evaluate the effect of sofosbuvir-daclatasvir therapy on symptomatic HCV-related MC and sustained virologic response (SVR) achievement. PATIENTS AND METHODS: This prospective cohort study was carried out on 120 patients with chronic HCV infection, clinically suspected to have MC, but only 63 of whom were positive for cryoglobulins. HCV-MC patients were treated with sofosbuvir 400 mg and daclatasvir 60 mg once daily for 3 months. The serum cryoglobulins levels, complement 3 (C3), complement 4 (C4) (using ELISA assay kits) and rheumatoid factor (RF) (using immunoturbidimetric assay kit), were measured in the included HCV infected patients (to confirm HCV-MC diagnosis), in addition to quantitave HCV-RNA assays, using real time PCR. All these measurements have been done before stating therapy and 12, 24 weeks post-therapy for assessments of immunological recovery, viral load and SVR. RESULTS: Significant increase in the serum cryoglobulin levels and RF with significant decrease in C3 and C4 serum levels were detected in only 63 out of 120 included HCV infected patients, upon whom the study has been completed. They showed significant decrease in their mean cryoglobulin levels from 41.47 µg/mL ±12.32 SD to 5.12 µg/mL ±3.59 SD then to 5.09 µg/mL ±3.02 SD, 12 to 24 weeks post-therapy respectively (p<0.001), with significant decline in RF concentrations and rise in C3 and C4 serum levels approaching the normal values. There were improvements in the presenting HCV-MC clinical manifestations in variable degrees, ranging from 5 (71.42%) in patients with glomerulonephritis to 62 (98.4%) in patients with purpura. Eighty-seven percent of the included patients showed complete response (clinical, virological and immunological recovery) and 13% showed partial response (virological and immunological recovery without clinical improvement of cryoglobulinemia associated manifestations). CONCLUSION: A combined therapy of sofosbuvir 400 mg and daclatasvir 60 mg once daily for 3 months was associated with a significant decrease in serum cryoglobulin levels and appears as a reasonable treatment option for HCV-associated MC.