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Tratamiento prolongado con interferón alfa-2b más lamivudina en pacientes con hepatitis crónica B y antígeno e positivo
Vilar Gómez,Eduardo; Grá Orama,Bienvenido; Arús Soler,Enrique; Ruenes Domech,Caridad; Dávila González,Yudith;
Revista Cubana de Medicina , 2007,
Abstract: 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.
Respuesta al tratamiento con lamivudina en pacientes con hepatitis crónica por virus B
Ma?as García,M. D.; Domper Bardají,F.; Hernández Albújar,A.; Piqueras Alcol,B.; Carpintero Briones,P.;
Anales de Medicina Interna , 2005, DOI: 10.4321/S0212-71992005001000008
Abstract: objective: the main objetive was to find a biochemistry and virology response in positive and negative hbeag patients who had been treating with lamivudine. furthermore, the secondary objetive was to made a description about kidney function changes that could be found in patients under treatment with lamivudine. method: thirty patients with chronic b hepatitis under treatment with lamivudine had been retrospectively studied since november 1999 to march 2004, in a digestive unit, in ciudad real hospital. results: twenty nine out of 30 patients were included, 8 out of 29 were positive hbeag, and 21 out of 29 were negative hbeag. seven patients had been treated with ifn. thus, 8 patients had been in need of adefovir treatment after lamivudine trial. the average of treatment had been 23.7 months (3 months- 46 months). in fact, none of them were changed from positive hbsag to negative hbsag. nevertheless, we have observed those results after lamivudine treatment. firtsly, 50% positive hbe ag patients have carried on negative dna results. although 25% positive hbe ag patients had conversed to negative hbe ag. but they did not show any anti hbe. secondly, 76% negative hbe ag patients had been suffering a dna decreased, even though some of them had had a negative dna results. thirstly, we found some lamivudine mutation (50% in possitive hbe ag patients and 19% in negative hbe ag patients). finally, all the patients with negative dna had maintained a normal ast and alt levels. thus, function renal had been normal under lamivudine trial. conclusion: according to several authors, the response to lamivudine treatment had been adequate in our population. nevertheless, our study have shown that antihbe levels had not been suffering any change during lamivudine treatment. in addition, we have found a smaller figures (19%) of lamivudine mutations in negative hbe ag patients than other studies (25% in patients who were followed up for 1 year).
Tratamiento de la hepatitis viral aguda c con interferón alfa 2b recombinante: Ensayo clínico
Arús Soler,Enrique; Rivera Reimón,Luis; Infante Velázquez,Mirtha; Pérez Lorenzo,Marlen; Soto Argüelles,Grisel; Gra Oramas,Bievenido; Padrón González,Guillermo; López Saura,Pedro;
Revista Cubana de Medicina , 2000,
Abstract: a clinical trial was carried out aimed at evaluating the efficacy and safety of interferon in a group of 13 patients with acute hepatitis c. the diagnosis was made according to biochemical criteria (alanine aminotransferase 2 ti-mes the normal value), serological criteria (presence of anti-hepatitis c virus antibodies) and histological criteria. treatment with recombinant interferon alfa 2b 3 000 000 iu/ml inj. was indicated 3 times a week during 13 weeks. it was proved that 53.8 % finished the period of treatment with normal alanine aminotransferase and that at the end of the follow-up 30.7 % had a mantained biochemical response. 4 patients (36.3 %) of the 11 that concluded the follow-up had a normal histology in the evolutive hepatic biopsy and of them 2 had a mantained biochemical response, which made us think they were cured. interferon was well tolerated and only 38.5 % of the patients showed secondary manifestations of toxicity. it was observed a predominance of cephalalgia, fever, myalgias and arthralgias. it was concluded that interferon should be used in patients with acute hepatitis c in extension protocols that will allow the generalization of this treatment in the future.
Tratamiento de la hepatitis crónica C con interferón alfa 2b recombinante: Ensayo clínico controlado aleatorizado
Arús Soler,Enrique; Rivera Reimón,Luis; Fernández Naranjo,Anayda; Infante Velázquez,Mirtha; Jorge Díaz,Rafael; Soto Argüelles,Grisel; López Saura,Pedro; Gra Oramas,Bienvenido;
Revista Cubana de Medicina , 2000,
Abstract: a multicenter randomized controlled trial was conducted on 35 patients suffering from chronic hepatitis c. 19 of them were treated with interleukin (group i), whereas the other 16 made up the control group. recombinant interleukin 2b alpha was used on a 9-month treatment scheme with doses that were gradually increased according to the biochemical response. a biochemical response of 57.9 % was obtained at the end of the treatment, while in the control group this response was of 12.5 %. the group of patients under treatment had a permanent biochemical response of 36.4 %. there was an improvement of the histological activity index of the study group, but in the control group this index was almost the same on the initial biopsy and the posttreatment biopsy. tolerance to interleukin was good. it was concluded that the interleukin effect on the group of treated patinets was beneficial.
Tratamiento de la hepatitis viral aguda c con interferón alfa 2b recombinante: Ensayo clínico
Enrique Arús Soler,Luis Rivera Reimón,Mirtha Infante Velázquez,Marlen Pérez Lorenzo
Revista Cubana de Medicina , 2000,
Abstract: Se llevó a cabo un ensayo clínico con el objetivo de evaluar la eficacia y la seguridad del interferón en un grupo de 13 pacientes con hepatitis aguda por virus C. Se realizó el diagnóstico siguiendo criterios bioquímicos (alaninoaminotransferasa 2 veces por encima del valor normal), serológicos (presencia de anticuerpos contra el virus de la hepatitis C) e histológicos. Se indicó tratamiento con interferón alfa 2b recombinante 3 000 000 UI por vía intramuscular 3 veces por semana por 13 sem. Se comprobó que el 53,8 % de los pacientes concluyeron el período de tratamiento con la alaninoaminotransferasa normal y que, al final del seguimiento, el 30,7 % tuvo una respuesta bioquímica mantenida; 4 enfermos (36,3 %) de los 11 que concluyeron el período de seguimiento tuvieron una histología normal en la biopsia hepática evolutiva y de ellos, 2 tuvieron una respuesta bioquímica mantenida, lo cual hace plantear la posibilidad que estuvieran curados. El interferón fue bien tolerado, sólo el 38,5 % de los enfermos presentó manifestaciones secundarias de toxicidad. Predominó la cefalea, la fiebre, las mialgias y las artralgias. Se concluyó que debe utilizarse el interferón en pacientes con hepatitis aguda C, en protocolos de extensión, que permitirán en un futuro la generalización de este tratamiento. A clinical trial was carried out aimed at evaluating the efficacy and safety of interferon in a group of 13 patients with acute hepatitis C. The diagnosis was made according to biochemical criteria (alanine aminotransferase 2 ti-mes the normal value), serological criteria (presence of anti-hepatitis C virus antibodies) and histological criteria. Treatment with recombinant interferon alfa 2b 3 000 000 IU/ml inj. was indicated 3 times a week during 13 weeks. It was proved that 53.8 % finished the period of treatment with normal alanine aminotransferase and that at the end of the follow-up 30.7 % had a mantained biochemical response. 4 patients (36.3 %) of the 11 that concluded the follow-up had a normal histology in the evolutive hepatic biopsy and of them 2 had a mantained biochemical response, which made us think they were cured. Interferon was well tolerated and only 38.5 % of the patients showed secondary manifestations of toxicity. It was observed a predominance of cephalalgia, fever, myalgias and arthralgias. It was concluded that interferon should be used in patients with acute hepatitis C in extension protocols that will allow the generalization of this treatment in the future.
Tratamiento de la hepatitis crónica C con interferón alfa 2b recombinante: Ensayo clínico controlado aleatorizado  [cached]
Enrique Arús Soler,Luis Rivera Reimón,Anayda Fernández Naranjo,Mirtha Infante Velázquez
Revista Cubana de Medicina , 2000,
Abstract: Se realizó un ensayo controlado aleatorizado multicentro constituido por 35 pacientes con diagnóstico de hepatitis crónica C, 19 correspondían al grupo tratado con interferón (grupo I) y 16 conformaron el grupo control. Se utilizó interferón alfa 2b recombinante en un esquema de tratamiento de 9 meses con dosis que se incrementaron de forma escalonada según la respuesta bioquímica. Se obtuvo una respuesta bioquímica al final del tratamiento de 57,9 %, mientras que en el grupo control esta cifra fue del 12,5 %. El grupo de pacientes tratados tuvo una respuesta bioquímica permanente de 36,4 %. Hubo mejoría del índice de actividad histológica del grupo estudio, mientras que en el grupo control este índice prácticamente fue similar en la biopsia inicial y en la evolutiva postratamiento. La tolerancia al interferón fue buena. Se concluyó que el efecto del interferón en el grupo de pacientes tratados fue beneficioso. A multicenter randomized controlled trial was conducted on 35 patients suffering from chronic hepatitis C. 19 of them were treated with interleukin (group I), whereas the other 16 made up the control group. Recombinant interleukin 2b alpha was used on a 9-month treatment scheme with doses that were gradually increased according to the biochemical response. A biochemical response of 57.9 % was obtained at the end of the treatment, while in the control group this response was of 12.5 %. The group of patients under treatment had a permanent biochemical response of 36.4 %. There was an improvement of the histological activity index of the study group, but in the control group this index was almost the same on the initial biopsy and the posttreatment biopsy. Tolerance to interleukin was good. It was concluded that the interleukin effect on the group of treated patinets was beneficial.
Lamivudina por tempo prolongado no tratamento da hepatite B cr?nica no estado de Mato Grosso
Souto, Francisco José Dutra;Pirajá, Ana Carolina da Silva;Silva, Graciana Soares da;Bottecchia, Marcelle;Gomes, Selma Andrade;
Revista da Sociedade Brasileira de Medicina Tropical , 2007, DOI: 10.1590/S0037-86822007000100004
Abstract: to assess the results from lamivudine treatment (100 mg or 150 mg) for chronic hepatitis b, 34 patients were followed at a clinic in cuiabá, mato grosso, central brazil. among them, 21 (62%) had liver cirrhosis and 24 (70%) were hbeag-positive. the viral genotype was determined for 18 patients, among whom genotype a was the most prevalent (12). the median follow-up was 27 months (range from 7 to 64 months). among the total, 23 (67%) presented a biochemical response after 2 to 24 months of treatment. among the 24 hbeag-positive subjects, 13 (54%) became hbeag-negative during the follow-up. among the anti-hbe-positive patients, 70% obtained normalization of aminotransferase levels. fourteen (41%) did not present any initial biochemical or serological response or presented breakthrough. the l180m and m204v mutations were found in six of the non-responders. four patients died after at least 21 months of lamivudine and three patients with liver cirrhosis developed liver cancer after 24 months. from the third year onwards, complications such as digestive system hemorrhage or liver cancer started to emerge. the present findings suggest that an early response to lamivudine treatment may be associated with better control over chronic hepatitis b.
Decrease in viral load at weeks 12 and 24 in patients with chronic hepatitis B treated with lamivudine or adefovir predicts virological response at week 48 En pacientes con hepatitis crónica B tratados con lamivudina y adefovir el descenso de la viremia en las semanas 12 y 24 tiene valor predictivo de respuesta virológica  [cached]
E. Llop,J. de la Revilla,F. Pons,B. Pe?as
Revista Espa?ola de Enfermedades Digestivas , 2009,
Abstract: Aim: the aim of our study was to evaluate the decrease in viral load (VL) that is able to predict antiviral treatment response at one year in patients with chronic hepatitis B. Methods: the clinical records of 66 patients, 31 treated with lamivudine (LAM) and 35 treated with adefovir (ADF), were retrospectively reviewed. We measured viral DNA at months 1, 3 and 6. Results: the LAM group showed virological response (VR) in 51.6% of patients. Baseline VL was higher in non responders (5.37 ± 1.16 vs. 7.01 ± 1.05; p < 0.001). Responders showed a higher percentage of VL decrease at month 3 from baseline (49.2 vs. 38.3%; p = 0.03). We designed a ROC curve and established a cutoff point for decrease of 30% that had 80% of negative predictive value (NPV). The ADF group showed VR in 57.1% of patients. Baseline VL was higher in nonresponders (4.67 ± 1.22 vs. 5.78 ± 1.34; p = 0.01). We observed a significant decrease in VL (log) at months 3 (2.6 ± 1.1 vs. 1.3 ± 1.3; p = 0.03) and 6 (2.6 ± 1.2 vs. 1.3 ± 1.2; p = 0.006). The percentage of decrease of VL from baseline was also statistically significant. We created ROC curves at months 3 and 6, and established the best cutoff points. At month 6 a decrease of 1 log in VL had a NPV of 80%, and a decrease of 20% in VL from baseline had 100% NPV. Conclusion: the decrease in viral DNA at weeks 12 and 24 can predict VR at one year in patients with chronic hepatitis B treated with LAM or ADF. This could optimize treatment.
Hepatitis viral aguda C: tratamiento con altas dosis de Interferón alfa-2b humano recombinante (Heberon alfa R) Acute viral hepatitis C: treatment with high dose of human recombinant alpha 2b interpheron (Heberon alfa R)
Agustín Mulet Pérez,Menelio Pullés Labadié,Martha Gámez Escalona,Agustín Mulet Gámez
Revista Cubana de Medicina Militar , 2009,
Abstract: INTRODUCCIóN: Para el tratamiento de la hepatitis viral aguda C se han propuesto diversos esquemas de tratamiento con Interferón. Se presenta nuestra experiencia con un esquema terapéutico diferente al estándar, recomendado en Cuba, de 3 millones de Interferon alfa-2b recombinante por via parenteral 3 veces por semana durante 6 meses. MéTODOS: Se realizó una revisión de las historias clínicas de 2 pacientes a quienes se les diagnosticó una hepatitis viral aguda C sobre la base de los datos clínicos y epidemiológicos, las alteraciones humorales y la positividad de los marcadores virales, y en uno de ellos con diagnóstico histológico. A ellos se les aplicó un esquema de 5 millones de Heberon alfa R por vía subcutánea durante 4 sem y a continuación 5 millones por igual vía 3 veces por semana hasta completar un total de 6 meses de tratamiento. RESULTADOS: Dos meses después de terminar el tratamiento, los pacientes continuaron asintomáticos; las TGP permanecieron normales y el ácidos ribonucleicos del virus C por técnica de reacción de cadena de polimerasa evolutivos resultaron negativos. CONCLUSIONES: El esquema terapéutico empleado en estos pacientes resultó ser efectivo, por lo que se recomienda su empleo en el tratamiento de la hepatitis viral aguda. INTRODUCTION: For the treatment of acute viral hepatitis C, a number of therapeutic regimes with Interferon has been put forward. This paper presented our own experience in the application of a therapy different from the Standard treatment recommended in Cuba, which consisted of the parenteral administration of 3 million doses of recombinant Interferon Alpha 2b three times a week for 6 months. METHODS: The medical records of two patients, who were diagnosed with acute viral hepatitis C on the basis of clinical and epidemiological data, humoral alterations and positive viral markers, were reviewed, using histological diagnosis in one of them. They were administered 5 million Heberon Alpha R subcutaneously for 4 weeks and then additional 5 millions using the same way of administration three times a week to complete 6 months of treatment. RESULTS: Two months after finishing the treatment, the patients remained asymptomatic, gluthamic-piruvic transaminase scores were normal and Virus C RNA proved to be negative after evolving PCR. CONCLUSIONS: The therapy used in these patients proved to be effective, so it is recommended to treat acute viral hepatitis C.
Efectos adversos del tratamiento con interferón alfa-2b humano recombinante y rivabirina en pacientes con hepatitis crónica C Adverse effects of treatment with the recombinant human type 2b alpha Interferon and rivabirine in patients presenting with chronic hepatitis C
Agustín Mulet Pérez,Menelio Pullés Labadié,Martha Gámez Escalona,Agustín Mulet Gámez
Revista Cubana de Medicina Militar , 2011,
Abstract: INTRODUCCIóN: el tratamiento de la hepatitis crónica C continúa siendo un reto. La combinación que mejores resultados ha demostrado, es la de interferón con ribavirina, pero puede originar efectos adversos con dificultades para la adherencia al tratamiento que en ocasiones, incluso, obligan a suspenderlo. OBJETIVO: identificar las reacciones adversas del tratamiento de la combinación de interferón con ribavirina. MéTODOS: se realizó un estudio de una serie de 13 pacientes con hepatitis crónica C, atendidos durante los a os 2006 y 2007 en consulta especializada del Hospital Universitario "Vladimir Ilich Lenin" tratados con interferón alfa-2b humano recombinante y ribavirina (Heberviron). RESULTADOS: la fiebre, cefalea, escalofríos, astenia, mialgias y artralgias fueron los efectos adversos más frecuentes, así como síntomas digestivos: anorexia, náuseas, epigastralgia; psíquicos: depresión; hematológicos: anemia y leucopenia. Se observó hipotiroidismo asociado a un cuadro reumatoide en una paciente en la que fue necesario suspender el tratamiento, así como en uno con trombopenia y otro con leucopenia. CONCLUSIONES: al indicar tratamiento con Heberviron al paciente con hepatitis crónica C, hay que tener presente, la frecuencia y magnitud de los efectos secundarios, pues pueden interferir con la adherencia y la respuesta al tratamiento, y ocasionar un impacto negativo en la calidad de vida de los pacientes. INTRODUCTION: The treatment of chronic hepatitis C is still a challenge. The combination with the better results is that of interferon with ribavirin, but it may to create adverse effects including difficulties to follow the treatment which on occasions, even to oblige us to suspend it. OBJECTIVE: To identify the adverse reactions to treatment with the combination of interferon and ribavirin. METHODS: A study was conducted in 13 patients presenting with chronic hepatitis C seen during 2006 and 2007 in the specialized consultation of the "Vladimir Ilich Lenin" University Hospital treated with human recombinant alpha-2b interferon (Heberviron). RESULTS: Fever, headache, chills, asthenia, myalgias and arthralgias were the more frequent adverse effects, as well as digestive symptoms: anorexia, nauseas, epigastralgia and the psychic type: depression, and hematologic type: anemia and leukopenia. Also, there was a hypothyroidism associated with a rheumatoid picture in a patient being necessary to suspend the treatment, as well as in another presenting with thrombopenia and another one with leukopenia. CONCLUSIONS: Prescribing the treatment with Heberviron in th
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