HEPATITIS C TREATMENT IN HEMODIALYSIS PATIENTS: THE EFFICACY AND SAFETY OF DIRECT-ACTING ANTIVIRALS IN THE REAL LIFE.

2017 ◽  
Author(s):  
Carvalho Liliana
Keyword(s):  
Hepatitis C ◽  
Real Life ◽  
Hemodialysis Patients ◽  
Efficacy And Safety ◽  
Direct Acting Antivirals ◽  
Hepatitis C Treatment ◽  
The Real ◽  
Direct Acting

Real-World Efficacy and Safety of Pangenotypic Direct-Acting Antivirals Against Hepatitis C Virus Infection

2019 ◽  
Vol 14 (3) ◽  
pp. 173-182 ◽  
Author(s):  
Riccardo Scotto ◽  
Antonio Riccardo Buonomo ◽  
Nicola Schiano Moriello ◽  
Alberto Enrico Maraolo ◽  
Emanuela Zappulo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Adverse Reactions ◽  
Safety Data ◽  
Real Life ◽  
Efficacy And Safety ◽  
Direct Acting Antivirals ◽  
Direct Acting ◽  
Very High

Background: Advances in the development of Direct-Acting Antivirals (DAAs), particularly pangenotypic drugs, have led to a high rate of hepatitis C virus (HCV) eradication. Notably, real- world studies have confirmed the efficacy and safety of pangenotypic DAA combinations reported in registration trials. The aim of this study was to review the treatment recommendations, and the efficacy and safety data of anti-HCV pangenotypic drugs reported in registration clinical trials and in recent real-life cohort studies. Methods: We reviewed the efficacy and safety data of pangenotypic anti-HCV drug combinations reported in original articles and in online conference abstracts. Results: Current pangenotypic drug combinations resulted in very high rates of sustained virologic response and few adverse reactions in real-life settings. SVR12 rates in real-life studies ranged from 90-100% depending on the pangenotypic combination, the HCV genotype and the stage of liver disease. Most adverse reactions reported in real-life settings were mild in intensity and rarely led to treatment discontinuation. These results are in accordance with those of clinical trials. Conclusion: Pangenotypic DAAs result in very high rates of sustained virologic responses and are well tolerated. However, they are contraindicated in patients with decompensated cirrhosis or advanced chronic kidney disease who failed previous DDA-based treatment. Further research is required to customize treatment to “unpackage” current DAA combinations and to develop generic drugs against HCV.

scholarly journals A real-life evaluation of the effect of direct-acting antivirals in hemodialysis patients with chronic hepatitis C

2019 ◽  
Vol 30 (Supp1) ◽  
pp. 39-40
Author(s):  
Nurten Nur Aydin ◽  
◽  
Firdevs Aksoy ◽  
Ilknur Yavuz ◽  
Serap Iskender ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Real Life ◽  
Hemodialysis Patients ◽  
Direct Acting Antivirals ◽  
Life Evaluation ◽  
Direct Acting

scholarly journals HEPATITIS C TREATMENT OF RENAL TRANSPLANT AND CHRONIC KIDNEY DISEASE PATIENTS: EFFICACY AND SAFETY OF DIRECT-ACTING ANTIVIRAL REGIMENS CONTAINING SOFOSBUVIR

2020 ◽  
Vol 57 (1) ◽  
pp. 45-49
Author(s):  
Fernanda Bellini Lunardi MICHELS ◽  
Ana Cristina de Castro AMARAL ◽  
Roberto José de CARVALHO-FILHO ◽  
Gustavo de Almeida VIEIRA ◽  
Ana Lucia da Silva SOUZA ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Hepatitis C ◽  
Renal Transplant ◽  
Adverse Events ◽  
Efficacy And Safety ◽  
Direct Acting Antivirals ◽  
Hepatitis C Treatment ◽  
End Of Treatment ◽  
Direct Acting ◽  
The Impact

ABSTRACT BACKGROUND: Direct-acting antivirals have revolutionized hepatitis C treatment, also for patients with chronic kidney disease (CKD), but some controversy exists regarding the use of sofosbuvir (SOF) in patients with glomerular filtration rate (GFR) <30 mL/min. OBJECTIVE: To evaluate the efficacy and safety of these regimens for hepatitis C treatment of patients with CKD and after renal transplantation, as well as the impact of SOF on renal function in non-dialysis patients. METHODS: All patients with hepatitis C and CKD or renal transplant treated with direct-acting antivirals at a referral center in Brazil between January 2016 and August 2017 were included. Efficacy was evaluated based on viral load (HCV RNA) and a sustained virological response (SVR) consisting of undetectable RNA 12 and/or 24 weeks after the end of treatment (SVR12 and SVR24) was defined as cure. Safety was determined by adverse events and ribavirin, when combined, was administered in escalating doses to all patients with GFR <60 mL/min. The impact of SOF on renal function was determined by the measurement of baseline creatinine during and after the end of treatment and its increase was evaluated using the Acute Kidney Injury Network (AKIN) classification. RESULTS: A total of 241 patients (52.7% females) with a mean age of 60.72±10.47 years were included. The combination of SOF+daclatasvir was the predominant regimen in 75.6% of cases and anemia was present in 28% of patients who used ribavirin (P=0.04). The SVR12 and SVR24 rates were 99.3% and 97.1%, respectively. The treatment was well tolerated and there were no major clinically relevant adverse events, with the most prevalent being asthenia (57.7%), itching (41.1%), headache (40.7%), and irritability (40.2%). Among conservatively treated and renal transplant patients, oscillations of creatinine levels (AKIN I) were observed in 12.5% of cases during treatment and persisted in only 8.5% after the end of treatment. Of these, 2.0% had an initial GFR <30 mL/min and this percentage decreased to 1.1% after SOF use. Only 0.5% and 1.6% of the patients progressed to AKIN II and AKIN III elevation, respectively. CONCLUSION: The direct-acting antivirals were safe and efficacious in CKD patients treated with SOF-containing regimens, with the observation of high SVR rates, good tolerability and few severe adverse events. The combination with ribavirin increased the risk of anemia and the administration of escalating doses seems to be useful in patients with GFR <60 mL/min. In patients with GFR <30 mL/min, SOF had no significant renal impact, with serum creatinine returning to levels close to baseline after treatment.

scholarly journals Efficacy of Direct-acting Antivirals in Hemodialysis Patients with Chronic Hepatitis C: A Real-life Retrospective Study

2019 ◽  
Vol 25 (3) ◽  
pp. 105-108
Author(s):  
Nurten Nur Aydın ◽  
Firdevs Aksoy ◽  
İlknur Yavuz ◽  
Serap İskender ◽  
Arzu Altunçekiç Yıldırım ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Retrospective Study ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Real Life ◽  
Hemodialysis Patients ◽  
Direct Acting Antivirals ◽  
Direct Acting

PP171 Cost And Effectiveness Of Chronic Hepatitis C Treatment In Brazil

2019 ◽  
Vol 35 (S1) ◽  
pp. 69-69
Author(s):  
Karin Hepp Schwambach ◽  
Mareni Rocha Farias ◽  
Giacomo Balbinotto Neto ◽  
Carine Raquel Blatt
Keyword(s):  
Hepatitis C ◽  
Sustained Viral Response ◽  
Real Life ◽  
High Price ◽  
Genotype 1 ◽  
Direct Acting Antivirals ◽  
Hepatitis C Treatment ◽  
Total Cost ◽  
Direct Acting ◽  
The Cost

IntroductionWith the discovery of new direct-acting antivirals, the cure for hepatitis C appears to be a reality, but its high price and the availability of new antivirals are a major obstacle. In Brazil, treatments for hepatitis C have been available in the public health system since the 1990s, and in 2015 were made available the antivirals sofosbuvir, daclatasvir and simeprevir. The calculation of the budgetary impact of this merger estimated expenditures between 467 and 666 million Reais (USD 121 and 172 million) per year. This study aims to present and discuss the cost and effectiveness of hepatitis C treatment with direct-acting antivirals with or without alfapeginterferon and ribavirin, based on real-life data, and compare it with the world scenario.MethodsWe analyzed the treatment data and outcomes of 253 patients from a retrospective cohort performed in a Specialized Care Service, in the city of Porto Alegre. In relation to costs, the direct costs of antiviral drugs, per unit (tablet), were considered according to financial receipts from public purchases. The total cost of the medications used by each individual in each treatment and the cost per cure obtained, expressed in Sustained Viral Response (SVR), were calculated.ResultsMost patients (66.8 percent) had genotype 1 of the hepatitis virus and 92.9 percent achieved SVR. The mean total cost of treatment of patients with genotype 1 was USD 5,862.31 and USD 6,310.34 per cure; while in patients with genotype 3 the cost was USD 5,144.27 and USD 5,974.76 per cure. The cost with the most commonly used treatment regimen, sofosbuvir, daclatasvir and ribavirin was USD 5,961.25 and USD 6,536.46 per cure. These values were 30 percent lower than the values estimated at the time of drug incorporation.ConclusionsCost and effectiveness data contextualize a real-life scenario in Brazil. The evaluated treatments presented good effectiveness, but high costs.

P0796 : New direct acting antivirals for hepatitis C treatment: first results in a real-life setting in France

2015 ◽  
Vol 62 ◽  
pp. S632
Author(s):  
A. Pariente ◽  
A.-J. Rémy ◽  
J.-P. Arpurt ◽  
I. Rosa-Hézode ◽  
C. Renou ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Real Life ◽  
Direct Acting Antivirals ◽  
Hepatitis C Treatment ◽  
Real Life Setting ◽  
First Results ◽  
Direct Acting

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.

Sign in / Sign up

Export Citation Format

Share Document