New direct action antivirals containing regimes to treat patients with hepatitis C chronic infection: first results from a national real-world registry of the Brazilian Hepatology Society

Cheinquer, Hugo; Coelho, Henrique Sérgio Moraes; Aires, Rodrigo Sebba; Quintela, E. D.; Lobato, Cirley Maria de Oliveira; Filho, J. E. Medeiros; Lima, L. B.; Borba, Luis Augusto; Hyppolito, Elodie Bomfim; Ivantes, Cláudia Pontes; Rezende, R. F.; Mello, C. B.; Lopes, E. A.; Sette, H; Lima, José Wellington de Oliveira; Ferreira, Adalgisa P.; Souto, F. D.; Nascimento, F. V.; Gomide, Gpm; Altikes, Isaac; Pinto, Patrick; Pedroso, M. A.; Pereira, Guilherme Stelko; Martinelli, Alc; Gonçalves, L. F.; García, Raúl López; Mendes, Luciano; Pessoa, F. P.; Ml, Ferraz; Terrabuio, D. B.; Figueira, N. A.; Ferreira, Paulo Vítor Campos; Filho, Raymundo Paraná Ferreira; Silva, R. A.; Rocha, Cristina Melo; Lyra, André Castro; Tovo, Cristiane Valle; Strauss, Ewa; Evangelista, Andrea; Parise, Edison Roberto

doi:10.1016/s0168-8278(17)31417-4

Cited by 4 publications

(8 citation statements)

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“…Our study included few patients with genotype 2 infection, consequently, we were not able to perform particular sub-analysis in this population. However, SVR rates (84.6% in ITT and 92.7% in mITT) among those patients were similar to another Brazilian cohort (88%) [ 25 ].…”

Section: Discussionsupporting

confidence: 71%

“…ALLY-3+ did not include decompensated cirrhosis and half of the patients received treatment for 16 weeks; while 15% of our cirrhotic patients had decompensated liver disease, and due to national guidelines, treatment duration was restricted to 12 weeks [ 10 , 11 ]. Among our findings, SVR in patients with genotype 3 and cirrhosis (79.4% in ITT and 85.7% in mITT) was somewhat lower than found among patients treated with SOF + DCV ± RBV the cirrhotic Spanish cohort (90.6 to100%), but comparable to the European compassionate study with 24 weeks duration treatment (88%), and to a Brazilian cohort (85%) [ 25 – 27 ]. We believe that genotype 3-infected patients, specially those with cirrhosis, are a difficult-to-treat populations that could benefit from treatment enlargement, as demonstrated in previous studies [ 26 – 27 ].…”

Section: Discussionsupporting

confidence: 60%

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All-oral direct antiviral treatment for hepatitis C chronic infection in a real-life cohort: The role of cirrhosis and comorbidities in treatment response

et al. 2018

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BackgroundHepatitis C virus (HCV) infection is the major cause of end-stage liver disease (LD) worldwide. The aim of this study was to assess sustained virological response (SVR) rates in a real-world cohort of patients with HCV infection treated with interferon-free direct antiviral agents (DAA).Patients and methodsAll patients with genotypes 1, 2 or 3 HCV infection who started interferon-free treatment at a university hospital from December 2015 through July 2017 were included. The primary outcome was SVR at post-treatment week 12 by intention-to-treat (ITT) and modified ITT (mITT) analysis.ResultsFive hundred twenty seven patients were enrolled, 51.6% with cirrhosis. Most patients received sofosbuvir + daclatasvir + ribavirin (60.7%) and sofosbuvir + simeprevir (25.6%). Overall SVR rates were 90.5% for ITT and 96% for mITT. SVR rates were higher in non-cirrhotic (94.2% in ITT and 96.8% in mITT) versus cirrhotic patients (87.1% in ITT and 95.2% in mITT). In ITT and mITT assessments, SVR rates were higher in patients with Child-Pugh A (n = 222, 88.7% and 95.7%, respectively) versus Child-Pugh B or C (n = 40, 80% and 90%, respectively); SVR rates were higher in patients with genotype 1 (n = 405, 92.1% and 98.2%), followed by genotype 2 (n = 13, 84.6% and 92.7%) and genotype 3 (n = 109, 84.4% and 88.4%). Lower comorbidity index (p = 0.0014) and absence of cirrhosis (p = 0.0071) were associated with SVR. Among cirrhotic patients, lower Model for End-Stage Liver Disease (p = 0.0258), higher albumin (p = 0.0015), and higher glomerular filtration rate (p = 0.0366) were related to SVR. Twenty-two cirrhotic patients (8%) had clinical liver decompensation during treatment. Complications of advanced LD were responsible for discontinuation of treatment and death in 12 and 7 patients, respectively.ConclusionTreatment with all-oral DAA achieved high SVR rates, particularly in patients without cirrhosis and few comorbidities. Advanced LD is associated to poor outcome, such as treatment failure and death.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionsupporting

confidence: 60%

All-oral direct antiviral treatment for hepatitis C chronic infection in a real-life cohort: The role of cirrhosis and comorbidities in treatment response

et al. 2018

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“…There are no data regarding the subject in the central region of Brazil. Our results are in line with other national studies that have previously analyzed the therapeutic efficacy of treatments in patients with chronic hepatitis C [14][15][16] .…”

Section: Discussionsupporting

confidence: 92%

Treatment of chronic Hepatitis C with daclatasvir, sofosbuvir and simeprevir in patients from the reference hospital of infectology in central Brazil/ Tratamento da Hepatite C crônica com daclatasvir, sofosbuvir e simeprevir em pacientes do hospital de referência de infectologia do centro do Brasil

Gonçalves¹,

Sirqueira²,

Aires³

et al. 2021

BJDV

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The drug treatment of hepatitis C represents a great therapeutic advance in favor of the elimination of the virus. The present study assessed the efficacy of treatment regimens involving direct action antivirals (DAAs), given to patients with chronic hepatitis C, attended at a referral hospital of infectology, central Brazil. This is a descriptive and cross - sectional study, based on the electronic database of the outpatient pharmacy, that evaluated the characteristics of patients and drug regimens involving DAA, from November 2015 to June 2017. Among 717 patients enrolled in this study, most of them had advanced liver fibrosis, were treatment naïve and HCV genotype 1 infected almost 80% of participants. A high efficacy of HCV treatment was achieved with 97% (95% CI: 94.9-98.2%) of SVR among the 431 patients who presented the results of viral load tests (HCV-RNA) at 12 weeks post-treatment. Patients infected with genotype 3 and who were cirrhotic had a lower SVR rate (87%). Treatment efficacy was not associated with age or sex among participants. The results of this study corroborate the findings in literature that showed a high efficacy of DAAs in the treatment of chronic hepatitis C, implemented through the clinical protocol and therapeutic guidelines for hepatitis C of the Ministry of Health in 2015. Many challenges must be overcome in order to combating viral hepatitis. In this context, the efficacy of HCV treatment it is an important issue to achieve the HCV elimination as a public health threat

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“…Finally, screening and full‐text assessment resulted in 20 included studies (14 manuscripts and 6 conference abstracts) that reported on SVR12 by DAAs in 7,393 individuals from South American countries (Figure 1). 27‐46 A total of 16 studies were published in English, two in Spanish 40,44 and two in Portuguese 29,33 . In addition, included studies were performed in Brazil (n = 11), Argentina (n = 4), Chile (n = 1), Colombia (n = 1), Peru (n = 1), and international collaborations in South America (n = 2) [Argentina, Chile, Colombia and Uruguay (n = 1); Argentina and Brazil (n = 1)].…”

Section: Resultsmentioning

confidence: 99%

“…Finally, screening and full-text assessment resulted in 20 included studies (14 manuscripts and 6 conference abstracts) that reported on SVR12 by DAAs in 7,393 individuals from South American countries ( Figure 1). [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] A total of 16 studies were published in English, two in Spanish 40,44 and two in Portuguese. 29,33 In addition, included studies were performed in Sofosbuvir/Simeprevir ± Ribavirin (SOF/SIM ± RBV), Sofosbuvir/ Ledipasvir (SOF/LDV) or Ombitasvir/Paritaprevir/Ritonavir + Dasa buvir ± Ribavirin (OBV/PTV/r/DSV ± RBV).…”

Section: Characteristics Of the Included Studiesmentioning

confidence: 99%

Effectiveness of direct‐acting agents for chronic hepatitis C treatment in South America: A systematic review and meta‐analysis

Filho

Piedade

Castro

et al. 2020

Journal of Viral Hepatitis

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The effectiveness of direct-acting agents (DAAs) for hepatitis C treatment in limited-resource settings remains unclear. We estimated the pooled sustained virological response rates of DAA therapy in South America. We searched online databases for studies that reported 12-week sustained virological response (SVR12) to hepatitis C virus (HCV) treatment in individuals living in South America. Pooled SVR12 in intention-to-treat (ITT) and per-protocol were estimated. Additionally, using all studies with available data, the pooled relative risk (RR) of SVR12 using a randomeffects model (DerSimonian-Laird) was estimated to compare effectiveness of DAAs in patients with or without cirrhosis, HIV co-infection or previous HCV therapy. Heterogeneity was assessed using the I 2 statistics. We identified 20 studies [14 manuscripts and 6 conference abstracts] comprising 7393 individuals from five countries [Brazil (n = 11), Argentina (n = 4), Chile (n = 1), Colombia (n = 1) and Peru (n = 1)] and two South-American collaborations. The pooled overall SVR12 rates [95% confidence interval (CI)] were 92.6% [90.2-94.7] and 95.5% [94.3-96.6] by ITT (11 studies; n = 4,153; I 2 = 84.2%) and per-protocol analysis (15 studies; n = 4,833; I 2 = 64.5%), respectively. The RR of SVR12 was similar in patients with or without HIV co-infection [4 studies; RR = 1.03 (0.99-1.07)] and those naive compared with treatment experimented-individuals [9 studies; RR = 1.01 (1.00-1.03)], but significantly higher in patients without cirrhosis compared with those with cirrhosis [11 studies; RR = 1.04

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New direct action antivirals containing regimes to treat patients with hepatitis C chronic infection: first results from a national real-world registry of the Brazilian Hepatology Society

Cited by 4 publications

References 0 publications

All-oral direct antiviral treatment for hepatitis C chronic infection in a real-life cohort: The role of cirrhosis and comorbidities in treatment response

All-oral direct antiviral treatment for hepatitis C chronic infection in a real-life cohort: The role of cirrhosis and comorbidities in treatment response

Effectiveness of direct‐acting agents for chronic hepatitis C treatment in South America: A systematic review and meta‐analysis

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