scholarly journals P1384EFFECT OF ANEMIA ON EFFICACY AND SAFETY OF CHRONIC HEPATITIS C TREATMENT AMONG RENAL PATIENTS USING DIRECT ACTING ANTI-VIRUS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Ahmed Elmowafy ◽  
Mohamed Abbas ◽  
Han Elmaghrabi ◽  
Reham Soliman ◽  
Salwa Elwasif ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Relative Risk ◽  
Kidney Disease ◽  
Serum Creatinine ◽  
Hemodialysis Patients ◽  
P Value ◽  
Efficacy And Safety ◽  
Hcv Treatment ◽  
Anemia Group ◽  
Direct Acting

Abstract Background and Aims With the advance of new direct acting antiviral, treatment of HCV became safer and easier. Renal impairment makes treatment of HCV more difficult due to poor drug tolerability. Anemia is a common side effect occurring in renal patients. Effect of anemia on the efficacy and safety of these drugs in those particular populations is a point of interest. Method This is a single center cohort study was held in Urology and Nephrology Center, Mansoura, Egypt, including 235 renal patients who were divided into 2 groups according to presence/absence of anemia; hemoglobin below 10.5 g/dL is considered cut-off value: 70 chronic kidney disease patients (CKD) (42 anemic and 28 non-anemic), 40 hemodialysis patients (HD) (24 anemic and 16 non-anemic) and 125 kidney-transplant recipients (KTRs) (40 anemic and 85 non-anemic). Hemodialysis patients received ritonavir-boosted paritaprevir and ombitasvir±ribavirin (OMV/PTV/RTV), KTRs received sofosbuvir and daclatasvir. CKD with eGFR >30 ml/min/1.73m2 received sofosbuvir and daclatasvir. CKD with eGFR <30 ml/min/1.73m2 received OMV/PTV/RTV. All patients were followed-up for 6 months after completing HCV treatment. Results: Demographics: Mean age was 49.17y for CKD, 43.2y for HD and 45.2y for KTRs. Most of them were males with body mass index around 23.8. Out of 235, 22 patients had been previously treated with interferon-IFN- (14 patients showed relapse after primary response on IFN and 8 patients could not tolerate IFN due to severe anemia, leucopenia and recurrent infection) and 7 patients had been co-infected with hepatitis B virus (all patients were cleared from the virus prior to HCV treatment). Efficacy: Rapid virologic response was achieved in all groups. 12-week sustained viral response (SVR-12) among CKD patients was 92.86% in anemic group and 96.42% in no-anemic group (p=91%). SVR-24 was lower in both groups. There were 16 relapse cases among CKD patients (11 in anemic group and 5 in non-anemic group; p value=0.69). Relative Risk for relapse incidence among anemic CKD patients was 1.4 with 95% CI 3.58 to 8.58 (p value: 0.42). Among HD patients, there was only 1 relapse case and it was in anemic group. All KTRs achieved SVR-12 and SVR-24. Safety: Deterioration of kidney function within 1 month from starting DAAs was the major side effect in both groups among CKD patients but it was more profound in anemic group (59.5%) (p value: 0.024). Deterioration of creatinine clearance was more obvious in anemic group (26.7±11.8mL/min, 21.28±12.97mL/min; p value: 0.014). More cases needed hemodialysis either temporary (3 cases) or permanently (13 cases) in anemic group (p value: 0.03 for temporary hemodialysis and 0.005 for permanent hemodialysis). Relative Risk for A/CKD incidence with anemia among CKD patients was 1.85 with 95% CI from 22.94 to 1.98 (p value: 0.04). Anemia was associated with rise of serum creatinine among kidney transplant recipient also. Graft impairment among anemia group was 30% (12 out of 40 patients) in comparison to 3.5% in no-anemia group (3 out of 85 patients); p value: 0.0002. Relative Risk for graft impairment with anemia among KTRs was 8.5 with 95% CI 6.95 to 2.64. Subsequently, drug interruption was more frequent among anemia group in both CKD and KTRS as treatment was suspended during AKI period. Regarding hemodialysis patients, the only difference was that worsening of anemia was more frequent among no-anemia group (p value: 0.0002). Ribavirin resulted in this this difference as no-anemia group received ribavirin while the other group did not receive it. Conclusion Direct-acting anti viral drugs are considered advance in treatment of hepatitis C infection and it is well tolerated by kidney disease patients. However, this particular population needs special care. Correction of anemia before starting DAAs may improve the outcome. Hemoglobin levels below 10.5 g/dL prior to DAAs are associated with rise of serum creatinine among KTRs and CKD patients.

scholarly journals Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials

2018 ◽  
Vol 5 (11) ◽  
Author(s):  
Jason Grebely ◽  
Massimo Puoti ◽  
Heiner Wedemeyer ◽  
Curtis Cooper ◽  
Mark S Sulkowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hepatitis C ◽  
Treatment Adherence ◽  
Efficacy And Safety ◽  
Substitution Therapy ◽  
Hcv Treatment ◽  
Opioid Substitution Therapy ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Opioid Substitution

Abstract Background We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. Methods Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. Results Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. Conclusions Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.

Hepatitis C Virus Infection in Maintenance Hemodialysis Patients: Recommendations for Diagnostics and Treatment

2016 ◽  
Vol 39 (12) ◽  
pp. 590-595 ◽  
Author(s):  
Pavlina Dzekova-Vidimliski ◽  
Aleksandar Sikole
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Antiviral Treatment ◽  
Antiviral Agents ◽  
Hemodialysis Patients ◽  
Maintenance Hemodialysis ◽  
Direct Acting Antivirals ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Direct Acting

Hepatitis C virus (HCV) infection is highly prevalent among patients treated with maintenance hemodialysis and is an important cause of morbidity and mortality. It is necessary to determine the HCV genotype and the viral load to monitor the clinical and laboratory features and to establish an optimal antiviral treatment strategy. Antiviral treatments are presented with a standard interferon-based regimen and new direct-acting antiviral agents. The advent of direct-acting antivirals has improved the efficacy and safety of HCV treatment for most patients, even in difficult-to-treat populations such as patients on hemodialysis. HCV treatment with direct-acting antivirals in hemodialysis patients is highly effective, with viral eradication rates similar to those seen in patients without chronic kidney disease and with acceptable adverse event profiles.

scholarly journals Successful Treatment of Hepatitis C with Simeprevir, Sofosbuvir, and Ribavirin in an HIV Coinfected Liver Transplant Patient with Advanced Chronic Kidney Disease

2016 ◽  
Vol 2016 ◽  
pp. 1-4 ◽  
Author(s):  
Anna Maruyama ◽  
Trana Hussaini ◽  
Nilufar Partovi ◽  
Siegfried R. Erb ◽  
Vladimir Marquez Azalgara ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C ◽  
Kidney Disease ◽  
Renal Disease ◽  
Liver Transplant ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Coinfected Patient ◽  
Stage Renal Disease ◽  
Direct Acting

Although major advances have occurred in treating patients with hepatitis C virus (HCV) with the development of new direct-acting antivirals (DAAs), treatment of liver transplant recipients with HCV, human immunodeficiency virus (HIV) coinfection, and renal disease is challenging due to the lack of efficacy and safety data in this population. We report a case of successful HCV therapy in a postliver transplant HIV coinfected patient, with stage 4 chronic kidney disease, using an all-oral regimen of simeprevir, sofosbuvir, and ribavirin. The 51-year-old male achieved SVR24, and no specific HIV-related or transplant-related adverse events were documented during the treatment period. The new DAAs show promise for HIV coinfected patients and those with severe to end-stage renal disease (ESRD); however, robust clinical trials or large cohort studies will need to be conducted to confirm the efficacy and safety of these newer agents in this setting.

scholarly journals Acquiring Hepatitis-C Viral Infection during Maintenance Hemodialysis Patients at DHQ Hospital Sheikhupura:

2021 ◽  
Vol 4 (2) ◽  
Author(s):  
Yaris Hussain ◽  
Anum Sabir ◽  
Saba Naz ◽  
Nazish Munawar ◽  
Roshina Anjum
Keyword(s):  
Hepatitis C ◽  
Kidney Disease ◽  
Viral Infection ◽  
Hemodialysis Patients ◽  
Infection Prevention And Control ◽  
Maintenance Hemodialysis ◽  
P Value ◽  
Elisa Method ◽  
Increased Risk ◽  
Acute Kidney Disease

Background: End stage kidney disease (ESKD) is one of the end results of chronic kidney disease. In center hemodialysis is the most common renal replacement therapy (RRT) for these patients used in Pakistan. It is associated with increased risk of health care-related infections. Hepatitis-C is the frequent blood born viral infection in hemodialysis center. Its frequency is very high in hemodialysis patients as compared to general and even to thalassemia population. Purpose of the study: To assess the gravity of Hepatitis-C viral infection in hemodialysis patients. Methods: A retrospective cross-sectional study done in dialysis center of DHQ hospital Sheikhupura, Punjab, Pakistan in January 2018. All the patients who had started hemodialysis with HCV negative status and had remained on hemodialysis for more than three months were included in the study. Patients with Hepatitis-C positive status, acute kidney disease and on dialysis less than three months were excluded. All patients were tested by enzymes linked immune-sorbent essay (ELISA) method for HCV status. Results: Out of 153 Hepatitis-C negative patients at the time of initiation of dialysis, 60 (39.21 %) converted positive while 93 (60.78 %) were still HCV negative by ELISA method at the time of study. Number of dialysis were having significant p value. Conclusion: Most of the patients had acquired Hepatitis-C infection during in-center hemodialysis. This emphasizes the importance of stringent infection prevention and control practices

scholarly journals Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kao-Chi Chang ◽  
Shui-Yi Tung ◽  
Kuo-Liang Wei ◽  
Chen-Heng Shen ◽  
Yung-Yu Hsieh ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Real World ◽  
Population Analysis ◽  
Virologic Response ◽  
Efficacy And Safety ◽  
Hepatitis C Virus Infection ◽  
Direct Acting Antivirals ◽  
Evaluable Population ◽  
Direct Acting

AbstractClinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. The primary endpoint was sustained virologic response 12 weeks after treatment cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4%), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon; only < 1% exhibited elevated total bilirubin or aminotransferase levels with both regimens. Five drug discontinuations occurred due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.

scholarly journals Considering treatment-as-prevention scale-up for Australian prisons: a qualitative sub-study of expert stakeholders from the Australian ‘surveillance and treatment of prisoners with hepatitis C’ project (SToP-C)

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jake Rance ◽  
◽  
Lise Lafferty ◽  
Carla Treloar
Keyword(s):  
Hepatitis C ◽  
Primary Prevention ◽  
Critical Role ◽  
Scale Up ◽  
Treatment As Prevention ◽  
Structured Interviews ◽  
Hcv Treatment ◽  
Public Health Response ◽  
Direct Acting ◽  
Levels Of Support

Abstract Background With direct-acting antivirals dramatically reshaping the public health response to the hepatitis C virus (HCV), prisons are set to play a critical role in elimination efforts. Despite the theoretical demonstration of HCV treatment-as-prevention in prison in mathematical modeling, limited empirical data exist. The Australian ‘Surveillance and Treatment of Prisoners with Hepatitis C’ project (SToP-C) is the world’s first trial of HCV treatment-as-prevention in prison. Drawing on interviews with HCV expert stakeholders, this paper explores the factors respondents identified as crucial to the success of future scale-up. Accounting for such perspectives matters because of the influence expert discourse has in shaping implementation. Methods Semi-structured interviews were conducted with nineteen HCV experts working across key policy, advocacy, research and clinical dimensions of the Australian HCV response. Data were coded using qualitative data management software (NVivo 11). Analysis proceeded via a hybrid deductive and inductive approach. Results Notwithstanding concerns regarding the lack of primary prevention in Australian prisons, stakeholders reported broad levels of support for the intervention and for the future scale-up of HCV treatment. A number of considerations, both external and internal to the prison system, were identified as key. The principal external factor was an enabling political-cum-policy environment; internal factors included: obtaining support from prisons’ executive and custodial staff; promoting health within a security-first institutional culture; allocating time for treatment within prisoners’ tightly regulated schedules; ensuring institutional stability during treatment given the routine movement of prisoners between prisons; prioritizing the availability of retreatment given the paucity of primary prevention; and securing sufficient clinical space for treatment. Conclusion The challenges to implementation are considerable, ranging from macrolevel concerns to in-prison logistical matters. Nonetheless, we argue that prisons remain an obvious setting for treatment scale-up, not only for prevention and potential elimination benefit, but for the treatment opportunities they afford a socially disadvantaged and underserved population. While noting widespread concerns among respondents regarding the paucity of primary prevention in Australian prisons, results indicate broad levels of support among expert stakeholders for HCV treatment scale-up in prison.

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