Executive summary: Consensus document of the diagnosis, management and prevention of infection with the hepatitis E virus: Study Group for Viral Hepatitis (GEHEP) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).

Hepatitis E virus (HEV) infection is one of the main causes of acute hepatitis in both developed and developing countries. This infectious disease has a high prevalence and incidence in Europe. HEV infection has a greater clinical impact in vulnerable populations, such as immunosuppressed patients, pregnant women and patients with underlying liver disease. Therefore, the Study Group for Viral Hepatitis (Grupo de Estudio de Hepatitis Víricas, GEHEP) of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica, SEIMC) believed it very important to prepare a consensus document to help in decision-making regarding diagnosis, clinical and therapeutic management, and prevention of HEV infection.

Tratamiento de la hepatitis crónica por virus C con interferón pegilado cubano y ribavirina / Treatment of chronic hepatitis C with Cuban pegylated interferon and ribavirin

Introducción: es en la actualidad la asociación de interferón pegilado y ribavirina la terapia más aceptada internacionalmente para el tratamiento de la hepatitis crónica C. En el 2011 comienza la aplicación en Matanzas de dicha combinación, utilizándose el interferón pegilado cubano (PEG-Heberon), con el cual se abrió un nuevo camino en el manejo terapéutico de esta enfermedad. Objetivo: describir los primeros resultados en Matanzas de la aplicación del PEG-Heberon y la ribavirina en el tratamiento de la hepatitis crónica C. Métodos: estudio descriptivo-prospectivo. Universo, 19 pacientes procedentes de la Consulta Provincial de Hepatología del Hospital Universitario Clínico Qurúrgico Comandante Faustino Pérez. Las variables estudiadas fueron: sexo, grupo etáreo, tipo de paciente, forma de presentación, efectos adversos, conducta ante estos, respuestas bioquímica y virológica al tratamiento. Resultados: predominaron los pacientes del sexo femenino (57,9 %), edad promedio de 41,7 ± 9,2 años, vírgenes de tratamiento (73,7 %) y con forma clínica asintomática (68,4 %). Se registraron efectos adversos en el 100 % de los casos, todos los clínicos fueron leves y entre los hematológicos el 70,4 % resultaron leves. No se reportaron eventos graves ni suspensiones del tratamiento. Se obtuvo respuesta bioquímica al concluir tratamiento en el 89,4 % y sostenida en el 78,9 %. La virológica se logró en el 78,9 % al término del tratamiento y en el 68,4 % seis meses después de este. Conclusión: se logró una elevada adherencia a la terapia combinada resultando tolerada y segura para los pacientes con tasas aceptables de respuesta virológica sostenida (RVS).

Introduction: currently, the association of pegylated interferon and ribavirin is internationally the most accepted therapy for the treatment of chronic hepatitis C. The application of this combination began in Matanzas in 2011, using the Cuban pegylated interferon (PEG-Heberon), setting up a new way in the therapeutic management of this disease. Objective: to describe the first results of the PEG-Heberon and ribavirin application in the treatment of chronic hepatitis C in Matanzas. Methods: descriptive- prospective study. Universe: 19 patients from the provincial consultation of Hepatology of the University Clinic-surgical Hospital Comandante Faustino Pérez in the period from October 2011 to October 2013. The studied variables were: sex, age groups, type of patient, presentation way, adverse reactions, behavior against them, biochemical and virologic answers to treatment. Results: there it was a predominance of female patients (57,9 %); the average age was 41,7 ± 9,2 years; treatment-virgins (73,7 %) and asymptomatic clinical forms (68,4 %). There were adverse reactions in 100 % of the cases; all the clinical ones were mild and among the hematologic ones, 70,4 % were light. There were neither serious events nor cancelations of the treatment. There was a biochemical answer at the end of the treatment in 89,4 % and a maintained one in 78,9 %. The virological answer was achieved at the end of the treatment in 78,9 %, and six months after treatment in 68,4 % of the patients. Conclusion: a high adherence to the combined therapy was achieved, being tolerated and safe for the patient, with acceptable rates of continuous virological answers.

Directly observed therapy for chronic hepatitis C: a randomized clinical trial in the prison setting.

BACKGROUND: The diagnosis and treatment of chronic hepatitis C are major concerns in prisons. OBJECTIVES: The aim of this randomized clinical trial was to determine the extent to which directly observed therapy (DOT) improved the efficacy of the standard treatment for chronic hepatitis C in the prison setting. PATIENTS AND METHODS: A randomized clinical trial was carried out to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C (based on pegylated interferon alpha-2a and ribavirin). RESULTS: A total of 252 inmates were randomized, of which 244 were analyzed: 109 in the DOT group and 135 in the non-DOT group. The mean age was 35.88 years (SD 6.54), 94.3% were men, 72.1% reported intravenous drug use, 21.3% were HIV co-infected, and 55.3% had genotype 1 or 4. The patients received the study treatment for a median time of 33.9 weeks in the overall sample. Sustained virological response was achieved in 60.6% (95% CI, 51.17-69.22) of the DOT group and in 65.9% (95% CI, 57.59-73.38) of the standard therapy group (risk ratio=0.92; 95% CI, 0.76-1.12). The mean proportion of patients continuing the treatment was 83% (SD=31). Adverse events were reported in 93.4% of the patients, and serious adverse events were reported in 8.2%, with no significant differences between groups. CONCLUSIONS: Sustained virological response was remarkably high, although there were no differences between groups, probably due to high treatment adherence.

[Triple therapy in cirrhotic patients and those with advanced fibrosis: relevant aspects in clinical practice]. / Terapia triple en pacientes con fibrosis avanzada y cirróticos: aspectos relevantes en la práctica clínica.

The first-line option in the treatment of patients with advanced fibrosis and cirrhosis due to genotype 1 hepatitis C virus is currently triple therapy with boceprevir/telaprevir and pegylated interferon-ribavirin. However, certain limitations could constitute a barrier to starting treatment or achieving sustained viral response in these patients. These limitations include the patient's or physician's perception of treatment effectiveness in routine clinical practice-which can weight against the decision to start treatment-, the advanced stage of the disease with portal hypertension and comorbidity, treatment interruption due to poor adherence, and adverse effects, mainly anemia. In addition, it is now possible to identify patients who could benefit from a shorter therapeutic regimen with a similar cure rate. This review discusses these issues and their possible effect on the use of triple therapy.

Pharmacoeconomic analysis of the treatment of chronic hepatitis C with peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin in Spain.

BACKGROUND: An independent meta-analysis of randomized comparative trials of peginterferons alfa-2a and alfa-2b, both combined with ribavirin, analyzed the probability of achieving a sustained virological response (SVR). OBJECTIVE: To estimate the long-term cost-effectiveness of treatment of patients with chronic hepatitis C with peginterferon alfa-2a (180µg/week) plus ribavirin (800-1200mg/day) vs. alfa-2b (1.5µg/kg/week) plus ribavirin (800-1400mg/day), from the perspective of the Spanish National Health System. METHODS: A Markov model was developed with 7 health states to simulate lifetime disease progression. SVR was calculated from the meta-analysis data. Transition probabilities and health state utilities were obtained from published literature. Direct healthcare costs were obtained from the drug catalog, while costs of disease-related complications were obtained from published studies and healthcare cost database. Costs were expressed in 2010€. The annual discount rate applied was 3.5% for both costs and benefits. RESULTS: SVR rate for treatment with alfa-2a was higher than with alfa-2b; the differences were 6.0%, 7.6% and 8.7% for all genotypes, genotypes 1/4 and genotypes 2/3, respectively. Each patient would gain 0.469, 0.600 and 0.685 life-years and 0.155, 0.198 and 0.227 quality-adjusted life-years with alfa-2a vs. alfa-2b, for the respective genotypes. The cost saving per patient treated with alfa-2a would be €705, €672 and €1900, for all genotypes and for genotypes 1/4 and 2/3, respectively, alfa-2a being dominant. CONCLUSIONS: According to the present model, treatment of patients with chronic hepatitis C with peginterferon alfa-2a is cost-effective compared with peginterferon alfa-2b, both combined with ribavirin.

[To consider negative viral loads below the limit of quantification can lead to errors in the diagnosis and treatment of hepatitis C virus infection]. / Considerar negativa una carga viral expresada como menor del límite inferior de cuantificación puede inducir a error en el diagnóstico y manejo terapéutico de la hepatitis C.

INTRODUCTION: For years many clinical laboratories have routinely classified undetectable and unquantifiable levels of hepatitis C virus RNA (HCV-RNA) determined by RT-PCR as below limit of quantification (BLOQ). This practice might result in erroneous clinical decisions. AIM: To assess the frequency and clinical relevance of assuming that samples that are BLOQ are negative. MATERIAL AND METHOD: We performed a retrospective analysis of RNA determinations performed between 2009 and 2011 (Cobas/Taqman, lower LOQ: 15 IU/ml). We distinguished between samples classified as «undetectable¼ and those classified as «<1.50E+01IU/mL¼ (BLOQ). RESULTS: We analyzed 2.432 HCV-RNA measurements in 1.371 patients. RNA was BLOQ in 26 samples (1.07%) from 23 patients (1.68%). BLOQ results were highly prevalent among patients receiving Peg-Riba: 23 of 216 samples (10.6%) from 20 of 88 patients receiving treatment (22.7%). The clinical impact of BLOQ RNA samples was as follows: a) 2 patients initially considered to have negative results subsequently showed quantifiable RNA; b) 8 of 9 patients (88.9%) with BLOQ RNA at week 4 of treatment later showed sustained viral response; c) 3 patients with BLOQ RNA at weeks 12 and 48 of treatment relapsed; d) 4 patients with BLOQ RNA at week 24 and/or later had partial or breakthrough treatment responses, and e) in 5 patients the impact were null or could not be ascertained. CONCLUSIONS: This study suggests that BLOQ HCV-RNA indicates viremia and that equating a BLOQ result with a negative result can lead to treatment errors. BLOQ results are highly prevalent in on-treatment patients. The results of HCV-RNA quantification should be classified clearly, distinguishing between undetectable levels and levels that are BLOQ.

[Progress in hepatitis C treatment]. / Avances en el tratamiento de la hepatitis C.

Recent approval of new protease inhibitors (boceprevir and telaprevir) for the treatment of chronic hepatitis C, genotype 1, has meant a significant increase in the sustained viral response both in naive and previously treated patients. However, such efficacy increase has been accompanied by an increase in adverse events, sometimes serious, and new practical issues including different approaches to stop treatment and drug interactions that recommend a close follow-up of patients. The efficacy and safety of triple therapy in special populations such as cirrhotic and transplanted patients is less known and has some particulars, meaning that its administration requires an exhaustive monitoring.

Sustained virological response to pegylated interferon plus ribavirin leads to normalization of liver stiffness in hepatitis C virus-infected patients.

INTRODUCTION: Pegylated interferon plus ribavirin (Peg-IFN/RBV) therapy leads to improvements in liver stiffness measurements (LSM) in hepatitis C virus (HCV)-infected patients. However, the rate of LSM return to normal values in response to Peg-IFN/RBV is unclear. Thus, our aim was to assess the probability and factors associated with LSM normalization in HCV-infected patients receiving Peg-IFN/RBV. METHODS: This prospective observational longitudinal study included 160 HCV-infected patients, 111 (69%) with human immunodeficiency virus and receiving Peg-IFN/RBV, with baseline LSM ≥ 7kPa. The outcome variable was LSM normalization, i.e. a stable decrease in LSM below 7kPa after starting Peg-IFN/RBV. RESULTS: After starting Peg-IFN/RBV, 56 [35%, 95% confidence interval (95% CI): 28-42%] patients showed LSM normalization. The probability of LSM normalization was 21% (95% CI: 13.2-32.4%) at 12 months, and 51.3% (95% CI: 39.9-63.9%) at 24 months after Peg-INF/RBV initiation for individuals with sustained virological response (SVR), and 8.3% (95% CI: 4-16.6%) at 12 months and 11.3% (95% CI: 6-20.7%) at 24 months for those without SVR (p<0.001). For individuals with LSM ≥ 7kPa 24 weeks after the pre-planned end of treatment, LSM normalizations were only observed among those with SVR. Achievement of SVR [Hazard ratio (HR, 95% CI): 6.84 (3.39-13.81)] and lack of baseline cirrhosis [HR (95% CI): 4.17 (1.69-10)] were independently associated with LSM normalization after starting Peg-IFN/RBV. CONCLUSIONS: LSM normalizations during Peg-IFN/RBV treatment are more likely, and occur earlier among patients with SVR. In addition, LSM normalizations continue 24 weeks after the scheduled end of therapy, but only among individuals who reach SVR.

Reporte de un caso de falla hepática aguda por hepatitis autoinmune en una paciente en tratamiento con interferón pegilado para infección crónica por el virus de la hepatitis C / Acute hepatic failure due to autoimmune hepatitis in a patient treated for hepatitis

Se describe el caso de una mujer con hepatitis C crónica diagnosticada por criterios bioquímicos, serológicose histológicos, quien presentó hepatitis autoinmune aguda y falla hepática aguda luego de un año de iniciadotratamiento con interferón pegilado, y quien requirió trasplante ortotópico de hígado

We describe the case of a woman with chronic hepatitis C which had been diagnosed by biochemical, serologicaland histological criteria. She presented acute autoimmune hepatitis and acute liver failure a year afterstarting treatment with pegylated interferon and required orthotopic liver transplantation

Tratamiento de la infección en la hepatitis C y la hemofilia / Hepatitis C related with hemophilia treatment of infection

Para el tratamiento de la hepatitis C se han desarrollado nuevos protocolos terapéuticos basados en el interferón pegilado y la ribavirina, y además se ha informado la eliminación natural del virus en un grupo de enfermos, sin embargo, los estudios de costos de la asistencia médica revelan que están significativamente aumentados en los pacientes hemofílicos que sufren la infección con VIH y/o con el VHC. El impacto que la aparición de estas enfermedades de transmisión sanguíneas y las enfermedades emergentes han tenido en las terapias con factores de la coagulación y en la política de la donación de sangre, elevan el valor que cada día más se le atribuye a los productos recombinantes no dependientes de fuentes sanguíneas y a los procesos de inactivación viral para la terapia sustitutiva. Existen aún retos terapéuticos por la formación de aloanticuerpos inhibidores contra algunos de los productos concentrados de F-VIII o F-IX, sean naturales o recombinantes, y la existencia de inequidad y disparidad en la disponibilidad de los productos, derivada de diferencias en cuanto al estado de las licencias, así como a los altos precios, aún prohibitivos para la mayoría de los pacientes en varias regiones del mundo(AU)

To treat hepatitis C new therapeutic protocols has been developed, based on pegilated Interferon and Ribavirine, and also natural virus eradication in a group of patients, however, cost studies of medical assistance reveal that it is significantly increased in hemophiliacs suffering HIV-infection and/or and HCV. Impact of blood-transmitted diseases and emergent diseases on therapies with coagulation factors and on blood donation policies, raise the daily value attribute to recombinant products non dependent of blood sources, and to the processes of viral inactivation for substitution therapy. There are still therapeutic challenges for inhibitors haloantobodies formation versus some of the F-VIII or F-IX concentrated products, be natural or recombinant, and the existence of non-equity and disparity in availability of the products, derived from differences as for licence status, as well as the high and still prohibitive prices to most patients in some world regions(AU)

Tratamiento de la infección en la hepatitis C y la hemofilia / Hepatitis C related with hemophilia. Treatment of infection

Para el tratamiento de la hepatitis C se han desarrollado nuevos protocolos terapéuticos basados en el interferón pegilado y la ribavirina, y además se ha informado la eliminación natural del virus en un grupo de enfermos, sin embargo, los estudios de costos de la asistencia médica revelan que están significativamente aumentados en los pacientes hemofílicos que sufren la infección con VIH y/o con el VHC. El impacto que la aparición de estas enfermedades de transmisión sanguíneas y las enfermedades emergentes han tenido en las terapias con factores de la coagulación y en la política de la donación de sangre, elevan el valor que cada día más se le atribuye a los productos recombinantes no dependientes de fuentes sanguíneas y a los procesos de inactivación viral para la terapia sustitutiva. Existen aún retos terapéuticos por la formación de aloanticuerpos inhibidores contra algunos de los productos concentrados de F-VIII o F-IX, sean naturales o recombinantes, y la existencia de inequidad y disparidad en la disponibilidad de los productos, derivada de diferencias en cuanto al estado de las licencias, así como a los altos precios, aún prohibitivos para la mayoría de los pacientes en varias regiones del mundo.

To treat hepatitis C new therapeutic protocols has been developed, based on pegilated Interferon and Ribavirine, and also natural virus eradication in a group of patients, however, cost studies of medical assistance reveal that it is significantly increased in hemophiliacs suffering HIV-infection and/or and HCV. Impact of blood-transmitted diseases and emergent diseases on therapies with coagulation factors and on blood donation policies, raise the daily value attribute to recombinant products non dependent of blood sources, and to the processes of viral inactivation for substitution therapy. There are still therapeutic challenges for inhibitors haloantobodies formation versus some of the F-VIII or F-IX concentrated products, be natural or recombinant, and the existence of non-equity and disparity in availability of the products, derived from differences as for licence status, as well as the high and still prohibitive prices to most patients in some world regions.

Infección hepática crónica por el virus de la hepatitis B: unarevisión con énfasis en los aspectos terapéuticos / Chronic hepatitis B virus infection: a review with emphasis on therapy

Se calcula que 400 millones de personas en todo el mundo están infectadas crónicamente con el virus de la hepatitis B (VHB). Colombia ha pasado a tener una prevalencia baja con un 2% de la población positiva para el antígeno de superficie de este virus (HBsAg); sin embargo, la prevalencia varía entre las distintas regiones. Los portadores de VHB tienen mayor riesgo de desarrollar hepatitis crónica, cirrosis hepática (CH), falla hepática y carcinoma hepatocelular (CHC). El tratamiento de la infección crónica por el VHB busca frenar por completo la replicación viral e inducir la remisión del daño hepático antes de que se desarrolle CH o CHC. Actualmente la terapia farmacológica se hace, entre otros medicamentos, con interferón pegilado alfa 2a, lamivudina, adefovir y entecavir. Los pacientes con hepatitis aguda no necesitan tratamiento, aquellos con falla hepática fulminante se deben evaluar para trasplante y el tratamiento de la infección crónica se debe elegir según la gravedad y características de la enfermedad. El seguimiento de los pacientes con infección aguda por el VHB se debe hacer cada 1-3 meses para detectar la progresión hacia hepatitis crónica; para ese propósito se miden los niveles de aminotransferasas, bilirrubinas, tiempo de protrombina, albúmina sérica, alfa-fetoproteína y ADN VHB; también se hacen recuento de plaquetas, biopsia hepática, ultrasonido abdominal y endoscopia digestiva superior. A los pacientes en tratamiento con interferón pegilado se les deben medir cada seis meses el antígeno e (HBeAg), su correspondiente anticuerpo (anti-HBe) y el ADN VHB. En quienes reciben lamivudina, adefovir, entecavir u otros antivirales, estas mediciones se hacen cada 3-6 meses. Se están estudiando otros fármacos tales como: emtricitabine, clevudine, tenofovir, telmivudina y beta L nucleósidos. Las estrategias inmunomoduladoras incluyen el uso de citoquinas y la vacunación.

Despite vaccination campaigns around the world and the resolution of the disease in immunocompetent adults, it is estimated that 400 million people worldwide are chronically infected with the hepatitis B virus (HBV). The prevalence rate of this disease in the Colombian population is low, though variable among regions: only 2% are positive in tests for the surface antigen of this virus (HBsAg). Carriers of HBV have a higher risk of developing chronic hepatitis, cirrhosis (HC), liver failure and hepatocellular carcinoma (HCC). The aims of treatment for chronic HBV infection are to completely control viral replication and to induce remission of liver damage before HC or HCC may develop. Nowadays, pharmacological therapy of HBV infection is done, among others, with pegylated interferon alfa 2a, lamivudine, adefovir, and entecavir. Patients with acute hepatitis do not need to be treated, those with acute liver failure should be evaluated for transplantation, and therapy for chronic infection should be chosen according to the degree of severity and the characteristics of their disease. Patients with acute HBV infection should be monitored every 1 to 3 months in order to detect the progression toward chronic hepatitis; for that purpose the levels of aminotransferases, bilirubin, prothrombin time, serum albumin, alfa-fetoprotein and HBV DNA are determined, and platelet count, liver biopsy, abdominal ultrasonography and upper digestive endoscopy are carried out. In patients being treated with alfa 2ª pegylated interferon HBeAg, anti-HBe and HBV DNA must be measured every 6 months. These measurements should be made every 3 to 6 months in patients who use lamivudine, adefovir, entecavir or other antivirals. Other drugs with immunomodulatory or antiviral properties are being studied. The new antiviral agents include: emtricitabine, clevudine, tenofovir, telmivudine and beta L nucleosides. Immunomodulatory strategies include the use of cytokines and vaccination.

Virus B e interferón / Virus B and interferon

La aparición de nuevas drogas y formas de diagnóstico, han transformado la hepatitis crónica B de una enfermedad fatal a una manejable y aún curable. Se distinguen dos tipos de enfermedad crónica por virus B, la que se desarrolla con antígeno e positivo y la que cursa con antígeno e negativo. La enfermedad crónica puede presentarse con ALT normal, ALT en continua elevación, fluctuaciones de ALT sin llegar a ser normales o elevaciones intermitentes. El éxito de la terapia antiviral para el virus B incluye, suprimir la replicación viral al nivel más bajo posible, lograr mejoría bioquímica e histológica y prevenir el desarrollo de complicaciones. Existen dos estrategias de tratamiento para el virus B, una de duración limitada (interferones) y otra de largo plazo (análogos nucleós(t)idos). Existen factores que influencian favorablemente la respuesta al tratamiento con interferón: niveles bajos de HBV DNA, niveles altos de ALT, niveles bajos de HBeAg y genotipos A y B. En el manejo de la enfermedad crónica tanto por virus B e ( + ) y e ( - ) se han utilizado interferón αlfa y actualmente el interferón pegilado α-2a. El interferón pegylado también ha mostrado ser superior al interferón simple en cuanto a normalización de ALT, pérdida del HBe y pérdida sostenida del HBV DNA. El interferón pegylado también ha mostrado ser superior a la terapia combinada o a la lamivudina sola en cuanto a rangos de respuesta y seroconversión en e (+) y e (-). En los pacientes e (-) sigue existiendo controversia por ameritar tratamiento a largo plazo el uso de interferón o iniciar con análogos nucleósidos.

The appearance of new drugs and new forms of diagnosing has transformed chronic hepatitis B from being a lethal disease to becoming a treatable and even curable disease. There are two kinds of chronic hepatitis B, one that develops with antigen e positive and the other one with antigen e negative. This chronic disease can appear with normal ALT, ALT continuous elevation, and ALT fluctuations without becoming normal or intermittent elevations. The success of the antiviral therapy for HBVincludes, suppressing the replicative state to the lowest level possible, getting biochemical and histological amelioration; and preventing the development of complications. There are two strategies for HBV treatment, one with limited duration (interferon) and the other long term treatment (nucleotide analogue). There are factors that influence satisfactorily, the response to the treatment with interferon: low levels of HBV DNA, high levels of ALT, long levels of HBeAg and A & B genotypes. Alpha interferon and more recently Pegylated α-2a have been used for the management of HBVe (+) and HBVe (-). The Pegylated interferon has shown to be more effective than conventional interferon, in terms of ALT normalization, HBe loss, and sustainable loss of HBV DNA. The Pegylated interferon has also shown to be superior to the combined therapy or only to lamivudine, in terms of range response and seroconversion in e (+) and e (-). There is still controversy when treating patients with e (-) who need long term usage of interferon or those who need to start nucleoside analogue.

Efectividad del interferon pegilado y ribavirina en la respuesta viral sostenida en niños con Hepatitis C

El objetivo de este trabajo es analizar la eficacia del tratamiento combinado de Interferón Pegilado y Ribavirina en pacientes pediátricos. Materiales y métodos: 18 pacientes con hepatitis C crónica, presentaban ARNVHC positivo, viremia cuantitativa, genotipo; a todos se les realizó biopsia hepática previo al tratamiento. Se indicó tratamiento con Ribavirina e Interferón pegilado durante 1 año. A los 6 meses posteriores a la culminación del tratamiento se realizó ARNVHC. Resultados: las edades de los pacientes eran entre 3 y 13 años, 55,56% sexo femenino. La transmisión vertical fue del 22,23%. 3/18 suspendieron tratamiento. Hubo disminución estadísticamente significativa en la viremia de los pacientes sin respuesta viral sostenida. 40% no presentaban fibrosis y 40% fibrosis leve en la biopsia hepática. 14/15 eran genotipo 1; 1/15 genotipo 2. 11/15 se les realizó ARN a los 6 meses durante el tratamiento y a todos, 6 meses de haber culminado el tratamiento, se compararon ambas respuestas sin diferencia significativa. Se obtuvo 60% de respuesta viral sostenida. Conclusión: Aunque la progresión de la hepatitis C en niños es lenta, el tratamiento con interferón pegilado y ribavirina es útil en esta edad, ya que los niños tienen factores pronóstico favorables para obtener una respuesta viral sostenida.

The objective of this study is to evaluate the efficacy of combination therapy of Interferon and Pegylated Ribavirin in pediatric patients. Materials and methods: 18 patients with chronic hepatitis C, showed ARNVHC positive quantitative viremia, genotype; all liver biopsies were performed prior to treatment. treatment with pegylated interferon and ribavirin was given for 1 year. At 6 months after the completion of treatment ARNVHC was conducted. Results: Ages of the patients were between 3 and 13 years, 55.56% female. Vertical transmission was 22.23%. 3 / 18 suspended treatment. There was a statistically significant reduction of viremia in patients without sustained viral response. 40% had no fibrosis and 40% had mild fibrosis in the liver biopsy. 14/15 were genotype 1; 1 / 15 genotype 2.In 11/15 a RNA was performed at 6 months during treatment, culminating 6 months after treatment, both answers were compared with no significant differences. 60% sustained viral response. Conclusion: Although the progression of hepatitis C in children is slow, treatment with pegylated interferon and ribavirin is useful at this age because children have favorable prognostic factors to obtain a sustained viral response.