Peginterferon plus ribavirin and sustained virological response rate in HCV-related advanced fibrosis: a real life study

Silva, Giovanni Faria; Villela-Nogueira, Cristiane Alves; Mello, Carlos Eduardo Brandão; Soares, Elza Cotrim; Coelho, Henrique Sérgio Moraes; Ferreira, Paulo Roberto Abrão; Ruiz, Fernando J.

doi:10.1016/j.bjid.2013.05.007

Cited by 12 publications

(9 citation statements)

References 24 publications

(36 reference statements)

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“…have a 4%-67% chance of dying (3) . During the interferon-based therapy, Sustained Virologic Response (SVR) was around 40%-80%, but in cirrhotics it was approximately 20% (4) . However, its use in patients with decompensated cirrhosis was not permitted, mainly due to the risk of infection and death (5) .…”

Section: Resultsmentioning

confidence: 99%

Waiting Daas List Mortality Impact in HCV Cirrhotic Patients

Silva

Andrade

Moreira

2018

Arq. Gastroenterol.

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BACKGROUND: The infection for the hepatitis C virus (HCV) is a leading cause of liver-related morbidity and mortality through its evolution to liver cirrhosis, end-stage liver complications and hepatocellular carcinoma. Currently, the new drugs for the HCV infection, based on direct antiviral agents, have changed the outcomes in this setting. OBJECTIVE: To assess death incidence, during the wait for the treatment with the new drugs, and to analyze which independent variable (age, sex, ascite, HDA, albumin, α-fetoprotein, platelets and Meld score) had relation with death. METHODS: Prospective study with cirrhotic patients by HCV. Inclusion: cirrhotic patients by hepatic biopsy (METAVIR), clinic or image, detectable RNA (HCV). Exclusion: Other stages of hepatic fibrosis and hepatocellular carcinoma. Descriptive statistic in continue variables. Fisher Exact and Kaplan Meier and Cox Regression Analysis to assess the association of variables studied with death. P<0.05. RESULTS: A total of 129 patients were included. Of this, 73% were men. Mean age was 57.8±12.1, albumin of 3.5±0.6 mg/dL, platelets of 123.4±59.6 and Meld score of 10.59±3.56. The time of observation was 11.2±3.26 months, and the number of death 9/129 (6,9%). The Kaplan-Meier showed association between death with albumin lower than 2.9 (0.0006), MELD score higher than 15 (0.007) and α-fetoprotein higher than 40 ng/mL (<0.0001). Adjusted Cox Regression Analysis showed that α-fetoprotein higher than 40 ng/ml could be considered an independent risk for death. CONCLUSION: We conclude that, patients with advanced cirrhosis should be prioritized for treatment with direct antiviral agents.

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Section: Resultsmentioning

confidence: 99%

Waiting Daas List Mortality Impact in HCV Cirrhotic Patients

Silva

Andrade

Moreira

2018

Arq. Gastroenterol.

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“…The reason for the higher SVR rate can be due to the minimal liver fibrosis in the children. and cirrhosis are associated with lower SVR rate and higher relapse rate, especially in patients with HCV genotype-1 infection [14]. Other reasons which might improve SVR rate in children might be attributed to the lower rate of high-risk behaviors (intravenous drug use and alcohol consumption) and comorbidities [7].…”

Section: Discussionmentioning

confidence: 99%

High Response Rate to Pegylated Interferon Alpha and Ribavirin Combination Therapy in Hemophilic Children with Chronic Hepatitis C; A Case-Control Study

Mehrnoush

Alavian

Sharafi

et al. 2015

Pediatric Hematology and Oncology

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Scarce data is available on the efficacy of Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) combination therapy in hemophilic children with chronic hepatitis C. The aim of this study was to evaluate the efficacy of Peg-IFN and RBV combination therapy for hemophilic children infected with hepatitis C virus (HCV) in comparison with adult hemophilic patients with chronic hepatitis C. A case-control study comprised 31 pediatric hemophilic patients ages under 16 years with previously untreated HCV genotype-1 or -3 infection as the case group and 62 treatment naive adult hemophilic patients with chronic HCV infection as the control group. Case and control groups were matched case by case according to HCV genotype, HCV RNA level and rs12979860 polymorphism. All patients in the case and control groups were treated with Peg-IFN and RBV for 24-48 weeks according to HCV genotype. Sustained virological response (SVR) was achieved in 26 (83.9%) pediatric patients and in 39 (62.9%) of adult patients (P = 0.05, OR = 3.07, 95%CI = 1.03-9.09). The rate of SVR was not different according to HCV genotype, HCV RNA level, and rs12979860 polymorphism in both studied groups whereas achieving early virological response was associated with achievement of SVR in both groups. The efficacy of Peg-IFN and RBV combination therapy in hemophilic children with chronic hepatitis C is higher than that of adult hemophilic patients.

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“…The mean, maximum and minimum values of SVR rates for each of the regimens were also calculated from the effectiveness data of different real-life studies. To calculate the mean SVR for the DT with Peg-INF α-2a and RBV, five studies were considered, two of them performed in Brazil 14,15,16,17,18 . The calculations of mean effectiveness or mean SVR rates of the TT were based on the response rates of the study conducted at HCFMRP-USP and six other studies, among these, two multicenter prospective studies conducted in Europe 19,20,21,22,23,24 .…”

Section: Cost and Outcomementioning

confidence: 99%

Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C

et al. 2020

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Cost-effectiveness analysis is essential in health decision making. Several countries use it as synthesis of evidence to incorporate health technologies. The protease inhibitors (PI) boceprevir (BOC) and telaprevir (TVR) are indicated for chronic hepatitis C treatment and were incorporated in guidelines worldwide. Pre-marketing clinical trials showed higher sustained virological response rates in relation to previous therapies, but the incorporation of PIs generated a significant financial impact. The aim of this study was to discuss the relevance of cost-effectiveness analysis through a study that involved the inclusion of PIs in a clinical protocol. The analysis was part of a real-life study that included patients infected with hepatitis C virus genotype 1 treated in a tertiary university hospital in Brazil. Triple therapies (TT) with ribavirin (RBV), peginterferon α-2a (Peg-INF α-2a) and BOC or TVR were compared to dual therapy with RBV and Peg-INF α-2a. Sensitivity analysis of the cost-effectiveness ratio indicated an 88.2% chance of TTs presenting a higher cost per cure. The incremental cost-effectiveness ratios (ICER) exceeded the Brazilian gross domestic product (GDP) per capita by three times in all proposed scenarios. The sensitivity of ICER showed an 88.4% chance of TT not being cost-effective. The impact of PI incorporation was negative and the conduct about this could have been different if a previous cost-effectiveness analysis had been conducted.

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Peginterferon plus ribavirin and sustained virological response rate in HCV-related advanced fibrosis: a real life study

Abstract: Treatment of HCV in patients with advanced fibrosis should not be postponed. However, a very careful evaluation of cirrhotic patients must be performed before treatment is indicated and careful monitoring is required during treatment.

Cited by 12 publications

References 24 publications

Waiting Daas List Mortality Impact in HCV Cirrhotic Patients

Waiting Daas List Mortality Impact in HCV Cirrhotic Patients

High Response Rate to Pegylated Interferon Alpha and Ribavirin Combination Therapy in Hemophilic Children with Chronic Hepatitis C; A Case-Control Study

Cost-effectiveness analysis is a mandatory strategy for health systems: evidence from a study involving therapies for hepatitis C

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