ABSTRACT Introduction: Peutz-Jeghers syndrome is characterized by mucocutaneous hyperpigmentation and gastrointestinal hamartomas that can appear from the stomach to the anus. It has an autosomal dominant inheritance pattern and variable expressiveness. The diagnosis is based on clinical findings and histological appearance of the polyps. No association between this entity and telangiectasias and mitral valve prolapse has been reported so far. Objective: To describe the findings that made it possible to establish the diagnosis of Peutz-Jeghers syndrome in a patient and to provide genetic counseling. Case presentation: Thirty-six-year-old male patient with a history of mitral valve prolapse who attends a clinical genetics consultation with his wife to request genetic counseling due to the fact that their daughter was diagnosed with Peutz-Jeghers Syndrome and they want to know about the risk of having another affected child. On physical examination, a hyperpigmented macule on the lower lip and several of these on the gums were observed. With such findings and the antecedent of having a daughter with Peutz-Jeghers syndrome, the same diagnosis is made in the father. As data of interest, multiple telangiectasias on the thorax, neck and back were found in this individual. The studies carried out to identify the same cause were negative. Conclusions: The history and findings in this patient allowed us to make the diagnosis of Peutz-Jeghers syndrome as well as to provide genetic counselling. The first report of this disease associated with telangiectasias and mitral valve prolapse is presented in the scientific literature.

RESUMEN Introducción: El síndrome de Peutz-Jeghers se caracteriza por hiperpigmentación mucocutánea y hamartomas gastrointestinales que pueden aparecer desde el estómago hasta el ano. Tiene un patrón de herencia autosómico dominante y expresividad variable. El diagnóstico se basa en los hallazgos clínicos y la apariencia histológica de los pólipos. No ha sido reportado hasta ahora asociación de esta entidad a telangiectasias y prolapso de la válvula mitral. Objetivo: Describir los hallazgos que permitieron establecer el diagnóstico de Síndrome de Peutz-Jeghers en un paciente y brindar asesoramiento genético. Presentación del caso: Paciente masculino de 36 años de edad con antecedentes de prolapso de la válvula mitral que acude a consulta de genética clínica con su esposa para solicitar asesoramiento genético, debido a que tienen una hija con diagnóstico de Síndrome de Peutz-Jeghers y desean conocer el riesgo de tener otro hijo afectado. Al examen físico se observa mácula hiperpigmentada en labio inferior y varias de estas en encías. Con tales hallazgos y el antecedente de tener la hija Síndrome de Peutz-Jeghers se emite el mismo diagnóstico en el padre. Como dato de interés se constatan en este individuo múltiples telangiectasias en tórax, cuello y espalda. Los estudios realizados en busca de la causa de estas fueron negativos. Conclusiones: Los antecedentes y los hallazgos encontrados en el paciente permitieron realizar el diagnóstico de Peutz-Jeghers y brindar asesoramiento genético. Se presenta el primer reporte de esta enfermedad asociada a telangiectasias y prolapso de la válvula mitral en la literatura científica.

ABSTRACT Gastroenterology, hepatology and liver transplant exchanges between the USA and Cuba have mainly consisted of scientific events and short visits. This has facilitated Cuba’s inclusion in recognized scientific organizations, familiarity with Cuba’s biotech products for treatment of liver disease, and access by Cuban professionals to the highest level of scientific information for clinical practice. It has also given health professionals in the US a more accurate picture of Cuba’s health sector. The results of the Global Alcoholic Liver Disease Survey, which included Cuba and was designed and coordinated in the USA, opened doors to joint research and scientific publications. Until now, there have been no protocols for ongoing cooperation to enable bilateral clinical trials or continuing professional development in diagnostic, therapeutic and surgical techniques for hepatology and liver transplantation. There are many mutually beneficial research prospects in these areas. What has been accomplished to date, described in this article, is encouraging and sets the stage for future collaboration.

ABSTRACT INTRODUCTION Reference values for liver stiffness for healthy individuals vary worldwide. Different optimal cutoff values correspond to the stages of fibrosis in chronic liver disease. OBJECTIVES Characterize the distribution of liver stiffness in Cuban adults without liver disease and its association with age, serum uric acid and body mass index. METHODS A cross-sectional study was performed of 110 plasma donors recruited from the Havana Province Blood Bank January 2016 through February 2017. Measurements of liver stiffness were performed using a FibroScan elastography device on the same day of laboratory analyses and abdominal ultrasound. The Pearson coefficient was used to assess correlations, and the reference range was calculated using the mean and its 95% confidence interval. RESULTS Liver stiffness values observed ranged from 2.2–6.3 kPa. The reference range (95% CI) for the 110 subjects without known liver disease was 4.2–4.6 kPa (mean 4.4). A positive correlation was observed between liver stiffness measurements and body mass index (r = 0.255, p <0.01) and serum uric acid (r = 0.266, p <0.01). There was no correlation between liver stiffness and age. Liver stiffness in women was similar to that of men, 4.3 (2.4–6.1) and 4.5 (2.2–6.3) kPa, respectively (p = 0.086). CONCLUSIONS Liver stiffness in Cuban adults without liver disease ranges from 2.2–6.3 kPa. The reference range is 4.2–4.6 kPa. Body mass index and serum uric acid levels are positively associated with liver stiffness. CONTRIBUTION OF THIS RESEARCH This is the first Cuban study using FibroScan to measure liver stiffness; its results will enable better assessment of liver disease in clinical practice.

Hepatitis C is a significant health problem worldwide, with incidence estimates around 160 million people and 500 000 annual deaths. The limited success of treatments in chronic genotype 1 hepatitis C virus (HCV) patients and the numerous and significant adverse effects of the therapeutic treatment with pegilated interferon and ribavirin have encouraged the development of different direct-acting antivirals (DAAs) with promising results. This was also stimulated by advances of the knowledge on virus cell cycle and the properties of its structural properties. However, DAAs are very expensive and some of those compounds have developed multiple adverse events, all these limiting their use in certain infected populations. Moreover, its use does not prevent from HCV reinfections. Hence, new treatments, such as therapeutic vaccines, have arisen as additional or combined therapies against chronic HCV infection.

La hepatitis C constituye un problema de salud mundial, con estimados de más de 160 millones de personas infectadas. Esta enfermedad es responsable de alrededor de 500 000 muertes anuales. El éxito limitado del tratamiento en pacientes infectados con el virus de la hepatitis C (VHC), genotipo 1, así como los numerosos e importantes efectos adversos de la terapia con interferón pegilado más ribavirina, unido a los avances en el conocimiento del ciclo de vida y de las características de las proteínas estructurales del virus, han estimulado el desarrollo de diferentes antivirales de acción directa (AAD), muy prometedores en sus efectos terapéuticos. Sin embargo, estos nuevos productos son extremadamente costosos y además algunos de ellos han presentado múltiples eventos adversos, lo que limita su empleo en determinadas poblaciones de individuos infectados, y no evitan la reinfección con el VHC. Por lo que se necesitan tratamientos con vacunas terapéuticas como un tratamiento adicional o alternativo para las infecciones crónicas por el VHC.

170 million people are estimated to be infected with hepatitis C virus (HCV) worldwide. The persistence of the virus in the body is due to its ability to mutate and alterations in the immune response that occurs. There are theories linking this virus lymphoma genesis. The relative risk of HCV-infected patients suffering from non-Hodgkin lymphoma is 2-4 times higher than in uninfected subjects. This association has geographic variability. Countries where the association is stronger are Italy, Japan, and the United States, and it is lesser in Canada and northern Europe. Lymphoma of the marginal zone in B cells and lymphoplasmacytic are the most well-informed in association with HCV. Indolent non-Hodgkin lymphomas associated with HCV can be treated with antiviral therapy, but the aggressive forms require specific immunochemotherapy. Hepatitis C has been shown to be a significant risk factor for hepatic toxicity in patients needing chemotherapy.

Se estima que unos 170 millones de personas están infectadas por el virus de la hepatitis C (VHC) en todo el mundo. La persistencia del virus en el organismo es consecuencia de su capacidad de mutar y de las alteraciones en la respuesta inmunológica que produce. Existen teorías que relacionan este virus con la linfomagénesis. El riesgo relativo de que pacientes infectados con el VHC padezcan linfoma no Hodgkin (LNH) es de 2 a 4 veces mayor que en los sujetos no infectados. Esta asociación tiene variabilidad geográfica: los países donde esa asociación es mayor son Italia, Japón y Estados Unidos, y donde es menor son Canadá y los del norte de Europa. El linfoma de la zona marginal de células B y el linfoplasmocitico son los más reportados en asociación con el VHC. Los LNH indolentes asociados con el VHC pueden ser tratados con terapia antiviral, no así las formas agresivas que necesitan de inmunoquimioterapia específica. Se ha demostrado que la hepatitis C es un significativo factor de riesgo para la toxicidad hepática en los pacientes que necesitan quimioterapia.

The treatment of chronic hepatitis C with interferon alpha (IFN-a) is widely used. However, the relapse rate is high, and sustained response is only in 10-20%. A combined treatment based on the synergic antiviral effects described for IFN-a and ribavirin was used as a National Program in Cuba. The study enrolled 357 patients treated during 48 weeks with an injection of IFN-a, 3 times weekly, combined with oral ribavirin in daily doses, the doses adjusted to body weight. Sustained virological response was the efficacy end point, supported by biochemical and histological changes. Normalization in transaminase levels occurs in 60.5% of patients after the first 4 weeks, 71.4% at 26 weeks and 60.2% at the end of treatment. In similar moments, the viral load was undetectable in 42.9%, 42.6% and 37.0% respectively. The implementation of this National Program led to 49.0% and 29.7% of biochemical and virological sustained response respectively. A histological improvement was observed in 53.5% of evaluated patients. The treatment was well tolerated and almost all adverse reactions were attributable to IFN-a. The main adverse reports were: anemia, leucopenia, asthenia, fever, headache, arthralgias, anorexia and myalgia. Anti-interferon antibodies were developed in 38 patients, in 3 of them as neutralizing of antiviral activity. These results confirm the efficacy and security profile of both drugs as combined therapy for the chronic hepatitis C and represent the first clinical data generated from its extensive use in the Cuban general population. The virological response was in agreement with international reports for populations with similar characteristics.

El porcentaje de recaída tras el tratamiento de la hepatitis C crónica con interferón alfa (IFN-a) es elevado y la respuesta sostenida oscila entre el 10 y el 20%. El efecto antiviral sinérgico entre el IFN-a y la ribavirina fue la base para instaurar el tratamiento combinado mediante un programa nacional en Cuba. Se escogieron 357 pacientes que durante 48 semanas recibieron IFN-a, 3 veces por semana, y varias dosis de ribavirina según el peso corporal. La respuesta virológica sostenida fue la variable principal de eficacia, apoyada en las variaciones bioquímicas e histológicas. Tras las primeras 4 semanas, el 60.5% de los pacientes tenía la transaminasa normal; 71.4% en la semana 26, y 60.2% al concluir el tratamiento. En iguales momentos, la carga viral fue indetectable en 42.9, 42.6 y 37%, respectivamente. En 7 años de ejecución, se registraron 49 y 29.7% de respuesta bioquímica y virológica sostenida. Hubo una mejoría histológica en el 53.3% de estos pacientes. El tratamiento fue bien tolerado y casi todas las reacciones adversas se atribuyeron al IFN-a. Las principales fueron anemia, leucopenia, astenia, fiebre, cefalea, artralgias, anorexia y mialgias. En 38 pacientes se formaron anticuerpos anti- IFN-a y en 3 pacientes neutralizaron la actividad antiviral. Los resultados confirman la eficacia y el perfil de seguridad de esa combinación para tratar la hepatitis C crónica. Son los primeros datos clínicos tras su uso en la población cubana. La respuesta virológica coincide con la descrita en otras poblaciones con características similares.

INTRODUCTION Upper gastrointestinal endoscopy, traditionally performed in Cuba in specialized hospitals, was decentralized to the primary health care level in 2004 to make it more patient-accessible. OBJECTIVES Describe frequency and distribution of the principal symptomatic diseases of the upper gastrointestinal tract and their relation to the main risk factors associated with each in a sample of urban adults who underwent upper gastrointestinal endoscopy in primary care facilities in Havana in selected months of 2007. METHODS A multicenter cross-sectional study was conducted, including 3556 patients seen in the primary health care network of Havana from May through November 2007. The endoscopies were performed at the 22 polyclinics (community health centers) providing this service. Diagnostic quality and accuracy were assessed by experienced gastroenterologists using a validated tool. Patients responded to a questionnaire with clinical, epidemiologic, and sociodemographic variables. Univariate and multivariate analyses (unconditional logistical regression) were used to identify associated risk factors. The significance level was set at p < 0.05 (or confidence interval excluding 1.0). RESULTS The diagnoses were: gastritis (91.6%), duodenitis (57.8%), hiatal hernia (46.5%), esophagitis (25.2%), duodenal ulcer (15.8%), gastric ulcer (6.2%) and malignant-appearing lesions (0.4%). Overall prevalence of Helicobacter pylori infection was 58.4%. The main risk factors for duodenal ulcer were H. pylori infection (OR 2.70, CI 2.17-3.36) and smoking (OR 2.08, CI 1.68-2.58); and for gastric ulcer, H. pylori (OR 1.58, CI 1.17-2.15) and age >60 years (OR 1.78, CI 1.28-2.47). H. pylori infection was the main risk factor for gastritis (OR 2.29, CI 1.79-2.95) and duodenitis (OR 1.58, CI 1.38-1.82); and age >40 years for hiatal hernia (OR 1.57, CI 1.33-1.84). External evaluation was "very good" or "good" for 99.3% of endoscopic procedures and 97.9% of reports issued. CONCLUSIONS Gastrointestinal endoscopy performed in primary care yielded high quality results and important information about prevalence of the most common diseases of the upper GI tract and associated risk factors. This study provides a reference for new research and can inform objective recommendations for community-based interventions to prevent and control these diseases. The existence of a network of universally accessible diagnostic endoscopy services at the primary care level, will contribute to conducting further research.

Combination antiviral therapies have previously been used with success in patients suffering from hepatic cirrhosis caused by the hepatitis C virus (HCV). We present here the results of a multi-center clinical trial sponsored by the Institute of Gastroenterology, which included a total of 36 patients diagnosed with hepatic cirrhosis due to HCV, at class A stage in the Child scoring scheme. The patients were treated with interferon alfa 2b plus ribavirin during 48 weeks, estimating the efficacy of this combination through qualitative determinations of serum HCV RNA and the biochemical behavior of the hepatic enzyme alanine aminotransferase (ALAT). A sustained virological response was obtained in 25% of the patients, and 50% of the patients controlled their ALAT levels in a sustained manner. The results show that this treatment has a positive effect on cirrhotic patients. There are only a few studies in Cuba describing the results of this therapeutic combination in cirrhotic patients.

La terapia combinada antiviral se ha usado con éxito en pacientes con cirrosis hepática causada por el virus de la hepatitis C (VHC). Este artículo presenta los resultados de ensayos clínicos multicéntricos dirigidos por el Instituto de Gastroenterología de Cuba, para los cuales se seleccionó un grupo de 36 pacientes con cirrosis hepática por el VHC en estadio de Child A, tratados con interferón alfa 2b más ribavirina durante 48 semanas. Se evaluó la eficacia de la combinación terapéutica, mediante la determinación cualitativa del ARN del VHC y el comportamiento bioquímico de la enzima hepática alaninoaminotransferasa (ALAT). En el 25% de los pacientes hubo una respuesta viral sostenida, y en más del 50% de ellos, hubo una estabilidad de los parámetros normales de la ALAT. Los resultados mostraron el efecto positivo de este tratamiento en los pacientes cirróticos. Pocos estudios en Cuba describen los resultados de esta combinación terapéutica en pacientes cirróticos.

INTRODUCTION: chronic hepatitis C has reached the category of pandemic. The hepatitis C virus is the main cause of chronic hepatitis, hepatic cirrhosis, hepatocarcinoma and liver transplantation worldwide. OBJECTIVE: to identify the side effects of a combined therapy of recombinant interpheron alpha 2b plus ribavirin during the treatment and up to 8 weeks afterwards, as well as the main effects related to temporary or definitive withdrawal. METHODS: a pharmacological surveillance study was performed in which 122 patients with chronic hepatitis C, who had been seen at the Institute of Gastroenterology from May 2001 to May 2006, were included. Recombinant interferon alpha 2b (3 million units administered 3 times a week) plus ribavirin (1 000 or 1 200 mg daily depending on the body weight) was the therapy used for 48 weeks. RESULTS: of the total number of cases, 88.5 % had side effects; 79.5 % of which corresponded to pseudocold syndrome followed by hematological, neuropsychiatric and gastrointestinal manifestations, and other less frequent ailments. In the studied group, 6.6% had to interrupt their treatment temporarily due to some side effect different from anemia whereas 4 patients gave up the study, three affected by severe hemolytic anemia and one with uncontrollable hyperthyroidism. CONCLUSIONS: the combined therapy of recombinant interferon alpha 2b plus ribavirin proved to be safe; the most frequent side effect was pseudocold syndrome in the majority of cases. The hematological manifestations that made the patients to give up the study led to recommend a strict follow-up of hemoglobin levels and thorough diagnosis and treatment of the main side effects found in other systems and associated to this combined therapy.

INTRODUCCIÓN: la hepatitis crónica C ha adquirido rango de pandemia. El virus de la hepatitis C se ha convertido en la causa principal de hepatitis crónica, cirrosis hepática, hepatocarcinoma, y trasplante de hígado a nivel mundial. OBJETIVO: identificar los efectos adversos asociados a la terapia combinada interferón alfa 2b recombinante más ribavirina durante la evolución del tratamiento y hasta 8 semanas después de finalizado, así como los principales efectos asociados a salidas temporales o definitivas de esta terapia. MÉTODOS: estudio de farmacovigilancia cuya serie estuvo conformada por 122 pacientes con hepatitis crónica C atendidos en el Instituto de Gastroenterología desde mayo de 2001 hasta mayo de 2006. Se utilizó interferón alfa 2b recombinante (3 millones de unidades 3 veces por semana) más ribavirina (1 000 o 1 200 mg diarios en dependencia del peso corporal) durante 48 semanas. RESULTADOS: el 88,5 % del total de casos presentó efectos adversos; de ellos el 79,5 % correspondió al síndrome seudogripal, seguido de manifestaciones hematológicas, neuropsiquiátricas, gastrointestinales, entre otras menos frecuentes. El 6,6 % de la serie presentó salidas temporales del tratamiento por efecto adverso distinto de la anemia y 4 pacientes, salidas definitivas del estudio, tres por anemia hemolítica severa y uno con hipertiroidismo no controlable. CONCLUSIONES: la terapia combinada interferón alfa 2b recombinante más ribavirina resulta segura, donde el mayor número de casos presentó síndrome seudogripal como efecto adverso más frecuente. Las manifestaciones hematológicas asociadas a las salidas definitivas del estudio permitieron recomendar seguimiento estricto de la hemoglobina y profundizar en el diagnóstico y tratamiento de los principales efectos adversos presentes en otros sistemas y asociados a esta terapia.

The hepatitis C virus becomes in leading cause of chronic hepatitis, hepatic cirrhosis, hepatocarcinoma and liver transplant at world level. OBJECTIVE: The aim of present study is to determine the virological, biochemical and histological course of patients presenting with Chronic hepatitis C under a combination of recombinant Interferon alfa-2b plus Ribavirin and to identify the main factors associated with the rates obtained of virological response. METHODS: A non-controlled and multicenter phase IV clinical-therapeutical trial was sponsored by the Institute of Gastroenterology and the Genetics and Biotechnology Engineering Center from May, 2002 to May, 2006. Sample included 122 patients diagnosed with chronic hepatitis C fulfilling the predetermined inclusion and exclusion criteria. Recombinant Interferon alfa-2b (3 millions of t.i.d units) was used plus Ribavirin (1000 or 1200 mg daily depending on the body weight) during 48 weeks. RESULTS: We achieved a sustained biochemical and virological response rate of 32.8 and 50.8 %, respectively at week 72. A 41.3,% from the total of patients had a histological improvement at the expense of reduction of fibrosis and a few changes in inflammation level. CONCLUSIONS: Raking into account the global response rate achieved this combined treatment was considered effectiveness for chronic hepatitis C and we recommended to deepen in the knowledge of infection in Cuba, as well as in more efficient treatment options for this disease.

El virus de la hepatitis C se ha convertido en la causa principal de hepatitis crónica, cirrosis hepática, hepatocarcinoma, y trasplante de hígado a nivel mundial. OBJETIVO: El presente estudio estuvo dirigido a determinar la evolución virológica, bioquímica e histológica de los pacientes con hepatitis crónica C bajo terapia combinada Interferón a 2b recombinante más ribavirina e identifica los principales factores asociados a las tasas obtenidas de respuesta virológica sostenida. MÉTODOS: Ensayo clínico-terapéutico fase IV, abierto, no controlado y multicéntrico rectorado por el Instituto de Gastroenterología y el Centro de Ingeniería Genética y Biotecnología en el período comprendido de mayo de 2001 a mayo de 2006. La muestra estuvo conformada por 122 pacientes con hepatitis crónica C que cumplieron con criterios de inclusión y exclusión predeterminados. Se utilizó interferón a 2b recombinante (3 millones de unidades 3 veces por semana) más ribavirina (1 000 o 1 200 mg diarios en dependencia del peso corporal) durante 48 sem. RESULTADOS: Se obtuvo una tasa de respuesta virológica y bioquímica sostenida a la semana 72 de 32,8 y 50,8 % respectivamente. Un 41,3 % del total de pacientes experimentó mejoría histológica a expensas de la reducción de la fibrosis y pocos cambios en la inflamación. CONCLUSIONES: Teniendo en cuenta la tasa de respuesta global obtenida, se consideró como tratamiento eficaz para la hepatitis crónica C y se recomendó profundizar en el conocimiento de las características de la infección en Cuba así como en opciones de tratamiento más eficaces para esta enfermedad.

In treatment of compensating hepatic cirrhosis of viral etiology the maintained viral response with Interferon and Ribavirin is minor and it is accompanied of a greater frequency of adverse effects in relation to non-cirrhotic patients. However, due to the scarce therapeutical options for this group of patients and the need to retard the appearance of complications, was the reason of present paper. Authors present the results from a group of 36 patients diagnosed with hepatic cirrhosis from HCV in A Child's stage included in multicenter clinical trials, sponsored by the Institute of Gastroenterology; patients received a therapeutical scheme of Interferon alfa-2b plus Ribavirin during 48 weeks assessing their tolerance by clinical and hematologic adverse events. Results demonstrate that this treatment alternative is safe and well-tolerated.

En el tratamiento de la cirrosis hepática compensada de etiología vírica la respuesta viral sostenida con el interferón y ribavirina es menor y se acompaña de mayor frecuencia e intensidad de efectos adversos en relación con pacientes no cirróticos. No obstante, dadas las pocas opciones terapéuticas para este grupo de pacientes y la necesidad de retrasar la aparición de las complicaciones, nos motivamos a la realización de este trabajo. Se presentan los resultados de un grupo de 36 pacientes con diagnóstico de cirrosis hepática por el virus de la hepatitis C (VHC) en estadio de Child A incluidos en un ensayo clínico multicéntrico, liderado por el Instituto de Gastroenterología, a los que se les administró un esquema terapéutico de interferón alfa-2b más ribavirina por 48 sem, se evaluó su tolerancia a través de los eventos adversos tantos clínicos como hematológicos. Los resultados demuestran que esta alternativa de tratamiento es segura y bien tolerada.

A bibliographic review on the more significant features of historical course experienced by the antiviral therapies used in treatment of Chronic Hepatitis C virus was carried out due to the increasing incidence and prevalence of this disease with infection estimates about 3% of the world population. A updating was carried out on this subject matter from its origins with special emphasis on future perspectives of this therapeutics, nowadays under consideration by the international scientific community. For the carrying out of present work 69 bibliographic references were reviewed including the meta-analyses available in MEDLINE from 1998 up to present time, as well as the publications of researches results performed in our country on this subject.

Dada la creciente incidencia y prevalencia de la infección crónica por el Virus de la hepatitis cónica C, con estimados de infección de alrededor del 3 % de la población mundial, se realizó una revisión bibliográfica sobre los aspectos más relevantes de la evolución histórica que han experimentado las terapias antivirales utilizadas en el tratamiento de esta enfermedad. Se realizó una puesta al día sobre esta temática desde sus orígenes, con especial énfasis en las perspectivas futuras de esta terapéutica, actualmente en estudio por parte de la comunidad científica internacional. Para la realización de esta obra fueron consultadas 69 citas bibliográficas que incluyen metanálisis disponibles en MEDLINE desde 1998 hasta la actualidad, así como las publicaciones de los resultados de las investigaciones realizadas en nuestro país sobre este tema.

The seroconversion rates of e antigen attained with the current antivirals do not exceed 35 %. The combination of immunomodulator and antiviral has been theoretically the most accepted strategy in the last five years; however, the results in clinical practice have been contradictory. This paper is aimed at evaluating the efficacy and security of a treatment scheme prolonged for 52 weeks with alpha-2b interferon plus lamivudine in patients with e antigen positive chronic hepatitis B. 46 patients selected at random were studied: 23 received 150 mg of lamivudine daily during 4 weeks, lamivudine plus alpha-2b (10 MU every other day) for 24 weeks, followed by lamivudine in the same dose and frequency until completing the 52 weeks. Other 23 were administered 150 mg of lamivudine daily for 4 weeks plus alpha 2b interferon (5 MU every other day) during 52 weeks. It was found that the antigen seroconversion rates were similar in both groups. A marked proportion of patients with combined prolonged treatment proved to be negative to the viral DNA (52 % vs. 26p = 0.06) and the surface antigen (48 % vs. 26 %, p = 0.11) compared with the controls. The improvement in the histological activity rate was observed in 48 % of the patients treated with combined prolonged treatment against 22 % of the controls (p = 0.06) It was concluded that the prolonged treatment of interferon and lamivudine during 52 weeks may have clinical benefits on the rates of sustained viral DNA loss, surface antigen and the histological activity index.

Las tasas de seroconversión del antígeno e alcanzadas con los antivirales actuales no sobrepasan el 35 %. La combinación de inmunomodulador y antiviviral ha sido teóricamente la estrategia más aceptada en los últimos años; sin embargo, los resultados en la práctica clínica han sido contradictorios. Se realizó el presente trabajo para evaluar la eficacia y seguridad de un esquema de tratamiento prolongado durante 52 sem con interferón alfa-2b más lamivudina en pacientes con hepatitis crónica B y antígeno e positivo. Se estudiaron 46 pacientes asignados aleatoriamente: 23 recibieron 150 mg diarios de lamivudina por 4 sem, lamivudina más interferón alfa-2b (10 MU en días alternos) por 24 sem, seguido de lamivudina en la misma dosis y frecuencia hasta completar las 52 sem. Otros 23 recibieron 150 mg diarios de lamivudina por 4 sem y lamivudina más interferón alfa-2b (5 MU en días alternos) durante 52 sem. Se encontró que las tasas de seroconversión del antígeno fueron similares en ambos grupos. Una proporción significativa de pacientes con tratamiento combinado prolongado logró negativizar el ADN viral (52 % frente al 26 %, p=0,06) y el antígeno de superficie (48 % frente al 26 %, p=0,11), comparado con los controles. La mejoría en el índice de actividad histológica fue observada en el 48 % de los pacientes tratados con tratamiento combinado prolongado frente al 22 % de los controles (p=0,06). Se concluyó que el tratamiento prolongado deerferón y lamivudina durante 52 sem puede brindar beneficios clínicos en las tasas de pérdida sostenida del ADN viral, el antígeno de superficie y en el índice de actividad histológica.