Low Rates of Sustained Virologic Response with Peginterferon Plus Ribavirin for Chronic Hepatitis C Virus Infection in HIV Infected Patients in Rio de Janeiro, Brazil

PLOS ONE, Dec 2019

Background The standard treatment for chronic hepatitis C virus (HCV) infection in HIV-infected subjects is the combination of alfapeginterferon (PEG-IFN) plus ribavirin. We designed this study to evaluate the rate of SVR and predictors of SVR in a public health setting in Rio de Janeiro, Brazil. Methods Retrospective cohort study of HCV/HIV co-infected patients treated with PEG-IFN plus ribavirin from 2004 to 2011 in 3 outpatient units in Rio de Janeiro. Exposure variables included age, sex, CD4+ cell count, HCV genotype, HCV and HIV viral loads, liver histology (METAVIR fibrosis scoring system) and previous treatment. The main outcome measurement was SVR. Results 100 patients were included in this analysis. Median age was 47 years and 68% were male. 80%, 4%, 14% and 2% were infected with HCV genotypes 1, 2, 3 and 4, respectively. At baseline, 77% had HCV viral load greater than 800,000 IU/ml, 99% had CD4+ greater than 200 cells/mm3 and 10% had a diagnosis of cirrhosis. The treatment was withdrawn in 9% of the subjects (5% with adverse effects and 4% dropped out). SVR was observed in 27 (27%) of the 100 patients included. 13 (13%) subjects were classified as null-responders, 33(33%) as non-responders, 9 (9%) as breakthrough and 9(9%) as relapsers. In the multivariate model only being infected with genotype 2 or 3 (p<0.01) and having low levels of gamma glutamyl transferase (GGT) at baseline (p = 0.04), were predictive of SVR. Conclusion SVR in HCV/HIV co-infected subjects in a public health setting is similar to that observed in clinical trials, albeit very low. A delay in therapy initiation should be considered until new therapies as direct acting antiviral drugs (DAA) become widely available and tested in coinfected subjects.

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Low Rates of Sustained Virologic Response with Peginterferon Plus Ribavirin for Chronic Hepatitis C Virus Infection in HIV Infected Patients in Rio de Janeiro, Brazil

Brazil. PLoS ONE 8(7): e67734. doi:10.1371/journal.pone.0067734 Low Rates of Sustained Virologic Response with Peginterferon Plus Ribavirin for Chronic Hepatitis C Virus Infection in HIV Infected Patients in Rio de Janeiro, Brazil Halime Silva Barcaui 0 Gerson Carreiro Tavares 0 Silvia Beatriz May 0 Carlos Eduardo Branda o-Mello 0 Ma rcia Maria Amendola Pires 0 Paulo Feijo Barroso 0 Maureen J. Donlin, Saint Louis University, United States of America 0 1 Infectious Diseases Service, Department of Preventive Medicine, Hospital Universita rio Clementino Fraga Filho, School of Medicine, Universidade Federal do Rio de Janeiro , Rio de Janeiro , Brazil , 2 Hospital Universita rio Clementino Fraga Filho, School of Medicine, Universidade Federal do Rio de Janeiro , Rio de Janeiro , Brazil , 3 Hospital Gafree e Guinle, Universidade Federal do Estado do Rio de Janeiro , Rio de Janeiro , Brazil Background: The standard treatment for chronic hepatitis C virus (HCV) infection in HIV-infected subjects is the combination of alfapeginterferon (PEG-IFN) plus ribavirin. We designed this study to evaluate the rate of SVR and predictors of SVR in a public health setting in Rio de Janeiro, Brazil. Methods: Retrospective cohort study of HCV/HIV co-infected patients treated with PEG-IFN plus ribavirin from 2004 to 2011 in 3 outpatient units in Rio de Janeiro. Exposure variables included age, sex, CD4+ cell count, HCV genotype, HCV and HIV viral loads, liver histology (METAVIR fibrosis scoring system) and previous treatment. The main outcome measurement was SVR. Results: 100 patients were included in this analysis. Median age was 47 years and 68% were male. 80%, 4%, 14% and 2% were infected with HCV genotypes 1, 2, 3 and 4, respectively. At baseline, 77% had HCV viral load greater than 800,000 IU/ ml, 99% had CD4+ greater than 200 cells/mm3 and 10% had a diagnosis of cirrhosis. The treatment was withdrawn in 9% of the subjects (5% with adverse effects and 4% dropped out). SVR was observed in 27 (27%) of the 100 patients included. 13 (13%) subjects were classified as null-responders, 33(33%) as non-responders, 9 (9%) as breakthrough and 9(9%) as relapsers. In the multivariate model only being infected with genotype 2 or 3 (p,0.01) and having low levels of gamma glutamyl transferase (GGT) at baseline (p = 0.04), were predictive of SVR. Conclusion: SVR in HCV/HIV co-infected subjects in a public health setting is similar to that observed in clinical trials, albeit very low. A delay in therapy initiation should be considered until new therapies as direct acting antiviral drugs (DAA) become widely available and tested in coinfected subjects. - Competing Interests: Dr. Barroso has received research grants from NIH, FAPERJ, Abbott Laboratories and GlaxoSmithKline. He received lecture and travel fees from Bristol Myers Squibb and GlaxoSmithKline. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials. Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma, and is a leading cause of liver transplant in developed countries. HCV and HIV share similar routes of transmission and coinfection is common, being as high as 90% among intravenous drug users in certain geographic regions [1,2]. HIV infection affects the natural history of HCV infection [3]. Coinfected subjects have higher HCV viral load and higher rates of HCV transmission when compared to HCV monoinfected [4]. In addition, increased prevalence of chronic hepatitis C and faster progression to cirrhosis is seen in these subjects [5,6]. In the era of highly active antiretroviral therapy (HAART), coinfection has emerged as one of the major concerns for those caring for patients living with HIV [79]. The standard treatment for chronic HCV infection in HIV infected subjects is the combination of PEG-IFN plus ribavirin for 48 weeks. The rate of sustained virologic response: (SVR: HCV RNA below detection levels six months after treatment interruption using polymerase chain reaction assays), varies between 14 38% of those infected with HCV genotype 1 or 4 and 4473% of those infected with genotypes 2 or 3 as observed in large international clinical trials [1012]. There are scanty data evaluating HCV treatment responses among HIV-infected subjects in developing countries. The aim of this study was to assess the rate of sustained virologic response and its predictors in a cohort of HIV and HCV coinfected subjects in Rio de Janeiro, Brazil. Ethics Statement The study protocol was approved by the institutional review board of the 3 institutions: Hospital Universitario Clementino Fraga Filho/Universidade Federal do Rio de Janeiro; Hospital Federal dos Servidores do Estado; Hospital Gafree e Guinle, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro. Written consent was obtained from participants. Study Design, Setting and Study Population This was a retrospective cohort study conduc (...truncated)


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Halime Silva Barcaui, Gerson Carreiro Tavares, Silvia Beatriz May, Carlos Eduardo Brandão-Mello, Márcia Maria Amendola Pires, Paulo Feijó Barroso. Low Rates of Sustained Virologic Response with Peginterferon Plus Ribavirin for Chronic Hepatitis C Virus Infection in HIV Infected Patients in Rio de Janeiro, Brazil, PLOS ONE, 2013, Volume 8, Issue 7, DOI: 10.1371/journal.pone.0067734