bms-650032 and Renal-Insufficiency--Chronic

Topics: Carbamates; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Pyrrolidines; Renal Insufficiency, Chronic; Sulfonamides; Valine

Hepatitis C virus (HCV) infection is very common in maintenance hemodialysis patients, causing high morbidity and mortality. This study aimed to evaluate the effectiveness and adverse events of direct-acting antivirals (DAAs) in maintenance hemodialysis patients complicated with chronic hepatitis C in real-world clinical practice.In this retrospective observational study, hemodialysis patients with chronic hepatitis C infection in the Third Central Hospital of Tianjin outpatient were screened, and appropriate treatment plans were selected accordingly. Totally 25 patients diagnosed with chronic hepatitis C and treated with DAAs for 12 weeks or 24 weeks were included. The sustained virologic response (SVR) rate obtained 12 weeks post-treatment (SVR12) was evaluated. Laboratory indexes and adverse reactions during the treatment process were also assessed.A total of 25 cases met the eligibility criteria and provided informed consent. Except for 1 patient who discontinued the treatment due to gastrointestinal bleeding, the remaining 24 cases completed the treatment cycle with 100% rapid virologic response (RVR) and 100% SVR12, with no serious adverse reactions recorded.Maintenance hemodialysis patients complicated with chronic hepatitis C in Chinese real-world setting tolerate DAAs very well, with a viral response rate reaching 100%.

Topics: Alanine Transaminase; Amides; Antiviral Agents; Aspartate Aminotransferases; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Genotype; Hemoglobins; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Male; Middle Aged; Pyrrolidines; Quinoxalines; Renal Dialysis; Renal Insufficiency, Chronic; Retrospective Studies; RNA, Viral; Sofosbuvir; Sulfonamides; Valine; Viral Load

Combination therapy with Daclatasvir (DCV) plus Asunaprevir (ASV) has been proven effective in patients with chronic hepatitis C virus (HCV) infection. However, little is known as to the effect of this therapy in patients with reduced renal function. Focusing on CKD patients whose renal function has declined, the present trial addresses the efficacy and safety of this combination therapy in CKD patients with reduced estimated glomerular filtration rate (eGFR).. The study design is a single-center, retrospective longitudinal observational study enrolling 106 patients with (n = 29) or without (n = 77) CKD. After the treatment with combined DCV with ASV for chronic HCV genotype 1b, patients were followed for a total of 48 weeks and the comparison was made in clinical parameters between the two groups.. (1) The majority of patients in both groups achieved sustained virological response at 24 weeks (90.8 % in the non-CKD group, and 93.1 % in the CKD). (2)The reduction rate in HCV-RNA levels 2 weeks after commencing the treatment was faster in the CKD group than that in the non-CKD group (81.8 vs. 79.2 %, p < 0.01). (3) Three patients in the CKD group and 6 patients in the non-CKD group withdrew from the treatment because of the adverse events.. Combination therapy with DCV plus ASV for chronic HCV genotype 1b infection is useful and tolerable, not only in patients with normal eGFR, but also in those with CKD with declined eGFR. Viral eradication at an early phase of the treatment appears to be faster in CKD patients.

Topics: Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Glomerular Filtration Rate; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Japan; Kidney; Longitudinal Studies; Male; Pyrrolidines; Renal Insufficiency, Chronic; Retrospective Studies; RNA, Viral; Sulfonamides; Sustained Virologic Response; Time Factors; Treatment Outcome; Valine; Viral Load