Effectiveness and tolerability of direct-acting antivirals for chronic hepatitis C patients in a Southern state of Brazil

Ferreira, Vinicíus Lins; Borba, Helena Hiemisch Lobo; Wiens, Astrid; Pedroso, Fiona L.; Radunz, Vanessa Ferreira de Camargo; Ivantes, Claudia Alexandra Pontes; Kuniyoshi, Aline Satie Oba; Pontarolo, Roberto

doi:10.1016/j.bjid.2018.04.003

Cited by 22 publications

(34 citation statements)

References 25 publications

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“…SVR was high (98.1%), with no significant differences between groups, in agreement with other Brazilian studies that found an SVR of 91.6‐95% . International studies also showed high rates of response to treatment, ranging from 78.6‐90%, depending on the treatment regimen used …”

Section: Discussionsupporting

confidence: 89%

“…[24][25][26][27] SVR was high (98.1%), with no significant differences between groups, in agreement with other Brazilian studies that found an SVR of 91.6-95%. 13,28,29 International studies also showed high rates of response to treatment, ranging from 78.6-90%, depending on the treatment regimen used. 14,22,[30][31][32] The most recent Brazilian protocol recommends use of ribavirin for patients with cirrhosis, with a lower chance of SVR (genotype 3, men, aged >40 years), or by medical decision, with consideration of previous intolerance.…”

Section: Discussionmentioning

confidence: 97%

“…[9][10][11] However, few studies have been conducted in Brazil evaluating the safety of direct-acting antivirals. 12,13 Thus this study aimed to identify factors associated with the development of adverse drug reactions (ADRs) to new direct-acting antiviral agents for hepatitis C treatment associated or not to ribavirin at three centers in the Brazilian public health system.…”

Section: Introductionmentioning

confidence: 99%

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Predictors of adverse drug reactions associated with ribavirin in direct‐acting antiviral therapies for chronic hepatitis C

Cursino

Monteiro

Duarte

et al. 2019

Pharmacoepidemiology and Drug

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Purpose To identify factors associated with the development of adverse drug reactions (ADR) in ribavirin therapeutic regimens. Methods A multicenter, prospective study was conducted in three public health hospitals in Rio de Janeiro between November 2015 and March 2018. Inclusion criteria were defined by patient follow‐up at pharmaceutical consultation at the time of drug dispensing as those who used sofosbuvir in combination with simeprevir, daclatasvir, and/or ribavirin. All patients were invited to participate in the study during the first interview. Adverse drug reactions were reported according to the treatment regimen and frequency of occurrence. Statistical analysis was used to compare adverse reactions between treatments and their associated factors. Results A total of 405 patients were included in the study (mean age 59.6 ± 9.6 years); 61.0% were female, 88.1% were infected with genotype 1, and 65.4% were cirrhotic. The most prescribed treatment was the combination of sofosbuvir, daclatasvir, and ribavirin (55.3%). The majority of patients reported at least one ADR during treatment (83.2%), of which fatigue, anemia, and headache were the most common. Being female (OR = 1.86, [1.08‐3.20]) and use of ribavirin (OR: 2.39; 95% CI [1.38‐4.13]) were predictors for the development of ADR, which was also associated with development of anemia (OR: 10.28; 95% CI: [5.78‐18.30]). Treatment efficacy was 98.1%. Conclusions Direct‐acting antiviral has been shown to be safe and effective. Therefore, use of ribavirin is questionable due to associated adverse reactions and similar efficacy to other treatments.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

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Predictors of adverse drug reactions associated with ribavirin in direct‐acting antiviral therapies for chronic hepatitis C

Cursino

Monteiro

Duarte

et al. 2019

Pharmacoepidemiology and Drug

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“…Um estudo de coorte alemão demonstrou que 92% dos pacientes que utilizaram SOF e DCV alcançaram RVS, enquanto 93% dos pacientes que utilizaram SOF e SMV alcançaram RVS(WERNER et al, 2016). Em estudo de vida real brasileiro realizado por Ferreira e colaboradores, o uso de tratamentos compostos por SOF e DCV proporcionou taxas de RVS de aproximadamente 95%, enquanto as taxas de RVS com o uso de SOF e SMV foram de aproximadamente 92%(FERREIRA et al, 2018).A tabela 6 descreve as taxas de RVS dentro de cada variável analisada, separadas por esquema de tratamento utilizado. Model for End-stage Liver Disease.…”

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“…DCV e pacientes tratados com SOF e SMV para as variáveis: subgenótipo viral, presença de cirrose hepática, história de tratamento prévio e carga viral prétratamento. O mesmo estudo também não identificou diferenças nos resultados de RVS de pacientes que foram tratados por 12 ou 24 semanas, e que fizeram ou não uso de RBV associada aos esquemas de tratamento(FERREIRA et al, 2018). Descrição das frequências absoluta e relativa das RAMs 1 observadas em cada esquema de tratamento utilizado.…”

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Avaliação da efetividade e segurança dos novos fármacos de ação direta indicados no tratamento da hepatite C

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Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan

Mushtaq

Mansoor

Umar

et al. 2020

Journal of Medical Virology

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This study aims to evaluate the clinical effectiveness in terms of sustained virological response (SVR), predictors of SVR and safety of available second‐generation generic direct‐acting antivirals in Pakistani chronic hepatitis C patients. This is a retrospective study conducted in multiple centers of Pakistan from January 2015 to January 2019. The samples include patients infected with chronic hepatitis C virus, regardless of virus genotype, cirrhosis, or prior treatment. A total of 993 patients were included in the present study, with the majority receiving sofosbuvir with daclatasvir (95%), sofosbuvir with daclatasvir and ribavirin (4%), and sofosbuvir with ribavirin (1%). There were 96% cases of chronic hepatitis, 3% cases compensated cirrhosis, and 1% cases of decompensated cirrhosis. Genotype 3 (99.6%) was the most common genotype. Overall SVR after 12 weeks was 98% for all treatment regimens. High SVR12 was observed with sofosbuvir in combination with daclatasvir (98.5%), then sofosbuvir in combination with daclatasvir and ribavirin (90.2%) and sofosbuvir in combination with ribavirin (75%). SVR rates were high in chronic hepatitis C patients (98.2%) as compared with cirrhotic patients (92.1%) and it was high in treatment‐naive (98.8%) then interferon experienced patients (90.1%). In multivariate binary logistic regression analysis, patients’ education status, treatment strategy, viral load, and alanine aminotransferase had a statistically significant association with SVR at 12 weeks. No major adverse events occurred which required treatment discontinuation. Generic oral direct acting antiviralss (sofosbuvir with daclatasvir) achieved higher SVR12 rates and were well tolerated in this large real‐world cohort of genotype 3 infected patients.

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Effectiveness and tolerability of direct-acting antivirals for chronic hepatitis C patients in a Southern state of Brazil

Abstract: The results point to the effectiveness of second-generation direct-acting antivirals in hepatitis C virus Brazilian patients, especially those with genotype 1. Furthermore, that patients with genotype 3 need more attention and adjustments in available treatment options.

Cited by 22 publications

References 25 publications

Predictors of adverse drug reactions associated with ribavirin in direct‐acting antiviral therapies for chronic hepatitis C

Predictors of adverse drug reactions associated with ribavirin in direct‐acting antiviral therapies for chronic hepatitis C

Avaliação da efetividade e segurança dos novos fármacos de ação direta indicados no tratamento da hepatite C

Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan

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