Desafios do processo de implantação dos medicamentos das hepatites virais B e C no componente estratégico da assistência farmacêutica no Estado do Rio de Janeiro / Challenges with the strategic pharmaceutical care program in the state of Rio de Janeiro's implementation of the viral hepatitis B and C medicines

O Brasil é signatário do documento da Organização Mundial da Saúde (OMS) para eliminação das hepatites virais até 2030. Uma das estratégias para eliminação das hepatites virais é aumentar o número de diagnósticos e tratamentos. A migração dos medicamentos de hepatites virais crônicas B e C do componente especializado para o componente estratégico da assistência farmacêutica foi regulamentado pela portaria 1537 do Ministério da Saúde de Junho de 2020 e normatizada pela Nota Técnica 319 de 2020. Para essa transição foi organizado um cronograma com as etapas do processo e implantação do Sistema de Controle Logístico de Medicamentos (SICLOM) nos estados. O SICLOM é um sistema de cadastro de usuário, dispensação dos medicamentos, controle de estoque, avaliação dos critérios para prescrição dos medicamentos, além de emitir relatórios sobre quantidade de medicamentos dispensados. Uma etapa fundamental do processo foi a pactuação das Unidade Dispensadoras Municipais (UDM) no âmbito das Comissões Intergestores Regionais (CIR) e, posteriormente, na Comissão Intergestores Bipartite (CIB) para deliberar que essas unidades iniciassem o processo como farmácias dispensadoras de medicamentos de hepatites B e C no componente estratégico, utilizando o sistema SICLOM, no Estado do Rio de Janeiro. O objetivo deste trabalho é descrever o processo e avaliar os resultados relacionados ao número de pontos de atendimento e o quantitativo de tratamentos dispensados no período de julho de 2021 a fevereiro de 2022 no Estado do Rio de Janeiro. A metodologia compreendeu uma revisão da literatura sobre o papel do tratamento como estratégia de eliminação das hepatites virais e a descrição das atividades previstas e realizadas na linha do tempo desde o início do processo após o embasamento legal e da publicação das normativas e a extração dos dados e informações sobre o número de tratamentos do SICLOM. A migração resultou em 1084 tratamentos de julho a dezembro de 2021, correspondendo a 56,4% do total dos 1922 tratamentos dispensados pelo Componente Especializado da Assistência Farmacêutica (CEAF) durante todo o ano de 2020. A migração transcorreu com sucesso, aumentou de 29 polos de dispensação especializados para 61 UDM que são as farmácias do componente estratégico, tornando a dispensação mais ágil do que a espera anterior. Apesar dos efeitos negativos provocados pela pandemia pode-se considerar que houve um grande avanço na política pública de assistência às hepatites virais.

Brazil is a signatory country to the World Health Organization (WHO) document for the elimination of viral hepatitis by 2030. One of the strategies to eliminate viral hepatitis is to increase the number of diagnoses and treatments. The migration of drugs for chronic viral hepatitis B and C from the specialized component to the strategic component of pharmaceutical care was regulated by ordinance 1537 of the Ministry of Health of June 2020 and standardized by Technical Note 319 of 2020. A schedule was organized for this transition with the steps of the process and implementation of the logistics and dispensing system (SICLOM) in the states. SICLOM is a user registration system, drug dispensing, inventory control, evaluation of drug prescription criteria, in addition to issuing reports on the quantity of drugs dispensed. A fundamental step in the process was the agreement between the Municipal Dispensing Units (UDM) within the scope of the Regional Inter-management Commissions (CIR) and, later, in the Bipartite Inter-management Commission (CIB) to decide that these units would start the process as pharmacies that dispense hepatitis drugs. B and C in the strategic component, using the SICLOM system, in the State of Rio de Janeiro. The objective of this work is to describe the process and evaluate the results related to the number of service points and quantitative of treatments dispensed from July/2021 to February/2022 in the State of Rio de Janeiro. The methodology included a literature review on the role of treatment as a strategy to eliminate viral hepatitis, and the description of the activities planned and carried out in the timeline since the beginning of the process after the legal basis and the publication of norms, and the extraction of data and information on the number of treatments from SICLOM. The migration resulted in 1084 treatments from July to December 2021, corresponding to 56.4% of the total 1922 treatments dispensed by the Specialized Pharmaceutical Assistance Component (CEAF) throughout 2020. The migration was successful, increasing from 29 specialized dispensing centers to 61 DMUs, which are the pharmacies of the strategic component, making dispensing more agile than the previous wait. Despite the negative effects caused by the pandemic, it can be considered that there was a great advance in the public policy of assistance to viral hepatitis.

Liver transplantation in a patient with hepatitis B, C and D coinfection associated with hepatocellular carcinoma: a management strategy for a rare condition. Case report / Transplante hepático em paciente com coinfecção pelos vírus B, C e D associada a carcinoma hepatocelular: uma estratégia de tratamento para uma condição rara. Relato de caso

CONTEXT: Orthotopic liver transplantation (OLT) is the treatment of choice for end-stage liver disease. Cirrhosis due to hepatitis C infection is the leading indication for liver transplantation worldwide. However, patients who are given transplants because of viral liver diseases often present clinical coinfections, including hepatitis B together with hepatitis D. Currently, different strategies exist for patient management before and after liver transplantation, and these are based on different protocols developed by the specialized transplantation centers. CASE REPORT: We present a rare case of a 58-year-old man with chronic hepatitis B, C and D coinfection. The patient developed cirrhosis and hepatocellular carcinoma. His treatment comprised antiviral therapy for the three viruses and OLT. The patient's outcome was satisfactory. CONCLUSION: OLT, in association with antiviral therapy using entecavir, which was administered before and after transplantation, was effective for sustained clearance of the hepatitis B and D viruses. A recurrence of hepatitis C infection after transplantation responded successfully to standard treatment comprising peginterferon alfa-2A and ribavirin.

CONTEXTO: O transplante ortotópico de fígado (TOF) é o tratamento de escolha em pacientes com doença hepática terminal. A cirrose por hepatite C é a principal indicação de transplante hepático no mundo. No entanto, pacientes transplantados por hepatopatias virais frequentemente apresentam coinfecções, como hepatite B associada a hepatite D. Atualmente, existem diferentes estratégias de manejo em pacientes pré e pós-transplantados conforme diferentes protocolos de conduta de serviços especializados em transplante. RELATO DE CASO: Apresentamos o raro caso de um homem de 58 anos diagnosticado com as hepatites crônicas B, C e D. O paciente evoluiu com cirrose e carcinoma hepatocelular. O tratamento consistiu de terapia antiviral para os três vírus e de transplante ortotópico de fígado. O desfecho do paciente foi satisfatório. CONCLUSÃO: O transplante ortotópico de fígado, associado à terapia antiviral com entecavir antes e após o procedimento, foi eficaz na depuração sustentada dos vírus B e D. A recidiva do vírus C após o transplante respondeu com sucesso ao tratamento padrão com alfapeginterferon 2A e ribavirina.

Plan de acción para la prevención y el control de las hepatitis virales / Action plan for prevention and control of viral hepatitis

Un plan de acción para la prevención y control de las hepatitis virales que allana el camino para la eliminación de la hepatitis B y C como problemas de salud pública en las Américas para el año 2030, a través de la creación de planes nacionales de lucha contra la enfermedad, un mayor acceso a los medicamentos y el control de su uso, además de esfuerzos direccionados para alcanzar a grupos vulnerables y de alto riesgo.

Management of viral hepatitis in liver transplant recipients

Recurrence of viral hepatitis after liver transplantation (LT) can progress to graft failure and lead to a decrease in long-term survival. Recently, there have been remarkable improvement in the treatment of chronic hepatitis B (CHB) using potent antiviral agents. Combination of hepatitis B immunoglobulin and potent antiviral therapy has brought marked advances in the management of CHB for liver transplant recipients. Post-transplant antiviral therapy for hepatitis C virus infection is generally reserved for patients showing progressive disease. Acheiving a sustained virological response in patients with LT greatly ameliorates graft and overall survival, however this only occurs in 30% of transplant recipient using pegylated interferon and ribavirin (RBV). Direct acting antivirals such as protease inhibitors, polymerase or other non-structural proteins inhibitors are anticipated to establish the new standard of care for transplant recipients. In liver transplant recipients, hepatitis E virus infection is an uncommon disease. However, it can lead to chronic hepatitis and cirrhosis and may require retransplantation. Recently, 3-month course of RBV monotherapy has been reported as an effective treatment. This review focuses on the recent management and therapeutic approaches of viral hepatitis in liver transplant recipient.

Prediction of fibrosis progression in chronic viral hepatitis

Prediction of liver fibrosis progression has a key role in the management of chronic viral hepatitis, as it will be translated into the future risk of cirrhosis and its various complications including hepatocellular carcinoma. Both hepatitis B and C viruses mainly lead to fibrogenesis induced by chronic inflammation and a continuous wound healing response. At the same time direct and indirect profibrogenic responses are also elicited by the viral infection. There are a handful of well-established risk factors for fibrosis progression including older age, male gender, alcohol use, high viral load and co-infection with other viruses. Metabolic syndrome is an evolving risk factor of fibrosis progression. The new notion of regression of advanced fibrosis or even cirrhosis is now strongly supported various clinical studies. Even liver biopsy retains its important role in the assessment of fibrosis progression, various non-invasive assessments have been adopted widely because of their non-invasiveness, which facilitates serial applications in large cohorts of subjects. Transient elastography is one of the most validated tools which has both diagnostic and prognostic role. As there is no single perfect test for liver fibrosis assessment, algorithms combining the most validated noninvasive methods should be considered as initial screening tools.

Maraviroque para pacientes em terapia antirretroviral / Maraviroque for patients on antiretroviral therapy

INTRODUÇÃO: A política de acesso universal ao tratamento foi estabelecida em 1996, com a publicação da Lei Federal 9.313 que define como responsabilidade da União o acesso ao tratamento antirretroviral a pessoas que vivem com HIV/Aids (PVHA) no Brasil. Desde então, esta política vem determinando aumento da sobrevida e da qualidade de vida das PVHA no país. Atualmente, cerca de 217 mil pessoas estão submetidas ao tratamento antirretroviral (TARV) no País e cerca de 30 mil iniciam tratamento anualmente. Estudo realizado pelo Departamento de DST, Aids e Hepatites Virais (DDSTAIDSHV) da Secretaria de Vigilância em Saúde (SVS) demonstrou maior tempo de sobrevida entre PVHA cujo diagnóstico é estabelecido em períodos mais recentes. Aqueles com diagnóstico entre 1998 e 1999, apresentam média de sobrevida de 107 meses, bastante superior aos 58 meses daqueles com diagnóstico em 1996. Entre os determinantes de aumento da sobrevida inclui-se a introdução de antirretrovirais de terceira linha, especialmente novas classes de antirretrovirais. As recomendações de tratamento da multirresistência permitem obter supressão viral duradoura (carga viral indetectável), que está associada ao impacto favorável na mortalidade ao longo do tempo. O convívio com a replicação, resistência viral e falha terapêutica apresenta risco relativo de morte de 1,21 para cada 3 meses de atraso em realizar a mudança do tratamento , além de ocasionar desenvolvimento de multirresistência. MARAVIROQUE: DESCRIÇÃO DA TECNOLOGIA: Tropismo viral é a capacidade do vírus de penetrar e infectar células específicas do hospedeiro por meio de ligação a receptores. Essa habilidade de ligação à célula CD4 pode ocorrer pelo co-receptor CCR5 (vírus R5), co-receptor CXCR4 (vírus X4) ou por ambos os co-receptores (tropismo duplo). Antagonistas do co-receptor de quimiocina C-C tipo 5 (CCR5) inibem especificamente a entrada na célula CD4 e, portanto, bloqueiam a replicação da variante R5 do HIV após ligação ao co-receptor transmembrana CCR5. O inibidor do CCR5 disponível comercialmente é o maraviroque. OBJETIVOS DA INCORPORAÇÃO DO MARAVIROQUE: A introdução de novos ARV no país deve sempre buscar a redução da necessidade de indicação de enfuvirtida - devido a razões relacionadas a seu elevado custo, toxicidade e dificuldade de administração, que acarreta baixa adesão ao tratamento. O Departamento de DST, Aids e Hepatites Virais, com subsídio da Comissão Técnica Assessora para Terapia Antirretroviral em Adultos Infectados pelo HIV, reunida no ano de 2012 propõe a incorporação do maraviroque para pacientes multiexperimentados em terapia antirretroviral com os seguintes objetivos: -Oferecer nova classe de ARV para pacientes em uso de esquemas de terceira linha que apresentam falha virológica; -Reduzir a necessidade de novas indicações de enfuvirtida. DELIBERAÇÃO FINAL: Após discussão sobre as contribuições da consulta pública e não tendo sido apresentadas mais informações sobre o uso do medicamento, os membros da CONITEC deliberaram, por unanimidade, por recomendar a incorporação do medicamento maraviroque ao arsenal terapêutico nacional como uma opção adicional de resgate para pacientes com AIDS multiexperimentados que necessitam de terceira linha de tratamento, com a condição de que o custo diário desse medicamento não seja superior. DECISÃO: PORTARIA SCTIE-MS N.º 44, de 23 de outubro de 2012 - Torna pública a decisão de incorporar o medicamento maraviroque para pacientes em terapia antirretroviral no Sistema Único de Saúde (SUS).

Viral hepatitis in India.

Viral hepatitis is a major public health problem in India, which is hyperendemic for HAV and HEV. Seroprevalence studies reveal that 90%-100% of the population acquires anti-HAV antibody and becomes immune by adolescence. Many epidemics of HEV have been reported from India. HAV related liver disease is uncommon in India and occurs mainly in children. HEV is also the major cause of sporadic adult acute viral hepatitis and ALF. Pregnant women and patients with CLD constitute the high risk groups to contract HEV infection, and HEV-induced mortality among them is substantial, which underlines the need for preventive measures for such groups. Children with HAV and HEV coinfection are prone to develop ALF. India has intermediate HBV endemicity, with a carrier frequency of 2%-4%. HBV is the major cause of CLD and HCC. Chronic HBV infection in India is acquired in childhood, presumably before 5 years of age, through horizontal transmission. Vertical transmission of HBV in India is considered to be infrequent. Inclusion of HBV vaccination in the expanded programme of immunization is essential to reduce the HBV carrier frequency and disease burden. HBV genotypes A and D are prevalent in India, which are similar to the HBV genotypes in the West. HCV infection in India has a population prevalence of around 1%, and occurs predominantly through transfusion and the use of unsterile glass syringes. HCV genotypes 3 and 2 are prevalent in 60%-80% of the population and they respond well to a combination of interferon and ribavirin. About 10%-15% of CLD and HCC are associated with HCV infection in India. HCV infection is also a major cause of post-transfusion hepatitis. HDV infection is infrequent in India and is present about 5%-10% of patients with HBV-related liver disease. HCC appears to be less common in India than would be expected from the prevalence rates of HBV and HCV. The high disease burden of viral hepatitis and related CLD in India, calls for the setting up of a hepatitis registry and formulation of government-supported prevention and control strategies.

Autoimmune diseases and chronic viral hepatits

Autoimmune diseases may be associated with chronic viral hepatitis though the nature of the association is not clearly understood. Immune mediated response against viral antigens expressed on the hepatocytes may explain the liver damage in chronic viral infection. Associated diseases with chronic viral hepatitis such as glomerulonephritis, vasculitis and rheumatoid arthritis could be induced by immunological mechanisms including viral antigen-antibody production and circulating immune complex deposition. However, other diseases [autoimmune thyroiditis, TCP and Sjogren's syndrome] may be autoantigen mediated. The present study reviews the pathogenesis of autoimmunity, pathogenesis of chronic viral hepatitis and the role of molecular mimicry so as to try to answer the questions; Can hepatotropic viruses induce autoimmune diseases 1:320, positive thyroid autoantibodies, thyroid dysfunction and thrombocytopenia; immunosuppression may be justified. Low dose of steroids or cyclosporin-A or a combination of lower doses or Tacrolimus and Mycophenolate Mofetil. Viral activation should be observed. If both viral infection and autoimmune features are predominating; a short course of immunosuppression [2 weeks] is given followed by Interferon

Oromucosal Cytokine Therapy: Mechanism(s) of Action / 대한간학회지

Oromucosal cytokine therapy allows large amounts of cytokines to be administered with improved outcome and without dose limiting toxicity. Orally administered cytokines exert their effects by a novel two pronged mechanism of action. Firstly, specific populations of immuno-competent effector cells are activated in the oral cavity and migrate to the site of virus replication. Secondly, chemokines produced in the lymphoid tissue of the oral cavity enter the peripheral circulation and redirect activated lymphocytes to eliminate virus infected cells. Oromucosal IFN therapy constitutes an alternative and improved means of therapy for diseases such as chronic viral hepatitis which are currently treated parenterally with IFN alpha. The oral route also has obvious advantages for ease of administration and improved patient compliance. Furthermore, the availability of a well tolerated form of IFN therapy will also allow Type I IFNs to be used for the treatment of diseases such as upper respiratory tract virus infections, for which parenteral IFN therapy is currently precluded due to unacceptable toxicity.

Hepatitis sifilítica en paciente infectado con el virus de inmunodeficiencia humana / Syphilitic hepatitis in a patient infected with human immunodeficiency virus

Hombre de 34 años, con una semana de evolución de fiebre, cefalea y compromiso del estado general, a lo que se agregó posteriormente dolor en hipocondrio derecho, coluria e ictericia de piel y mucosas. El laboratorio evidenció leucopenia, plaquetopenia, hiperbilirrubi-nemia y gran aumento de las transaminasas. Se informó VDRL positivo » y más tarde un test de MHA-TP positivo. El estudio para hepatitis A, B, C, citomegalovirus y virus de Epstein Barr fue negativo, la IgG para virus de hepatitis E fue positiva. La biopsia hepática demostró alteraciones concordantes con hepatitis sifilítica. El paciente recibió penicilina benzatina 2.400.000 U.I. una vez a la semana durante tres semanas con buena respuesta. Después del alta se conoció reacción de polime-rasa en cadena positiva para el virus de inmuno-deficiencia humana (VIH). Este caso ejemplifica una manifestación poco usual de la sífilis secundaria, a la cual atribuimos la complicación hepática, que se presenta prácticamente pura en un paciente infectado con el VIH, dato conocido sólo después del alta

Coinfections with hepatitis g and/or c virus in hepatitis B-related chronic liver disease.

Concurrent infections with HGV and/or HCV (HGV/HCV) were investigated in 196 patients with HBV-related chronic liver disease (115 chronic hepatitis, 31 liver cirrhosis, 50 hepatocellular carcinoma), and in 100 HBsAg carriers. Coinfections were detected in 18 (9.2%) patients with HGV (10) or HCV (5) or both agents (3), but in none of the HBsAg carriers. Patients with coinfection were more frequently exposed to blood transfusions (55.6% vs 5.6%) and also were more commonly anti-HBe positive. Serum levels of HBV-DNA were lower in patients with HCV coinfection than in those coinfected with HGV. Interferon was administered to 39 patients with chronic active hepatitis including 7 patients with HGV/HCV coinfection. Sustained clearance of HBV-DNA was observed in 10 (25.6%) patients who were solely infected with HBV. These patients were significantly younger and had much lower histological scores than non-responders. Patients with HCV coinfection had significantly higher pre-treatment histological scores than those without HCV. After interferon treatment, a significant reduction in histological scores was observed in all patients except those coinfected with HGV/HCV. None of the 7 patients with coinfection had sustained clearance of HBV-DNA or HCV-RNA, and only one had cleared HGV-RNA. These results suggest that parenteral exposure is a risk factor for HGV/HCV coinfection in chronic HBV infection. HGV infection shows no significant impact on chronic HBV infection. HCV coinfection appears to inhibit HBV replication, but causes more severe chronic hepatitis and increases resistance to interferon therapy.

Hepatitis virales / Viral hepatitis

En esta revisión se describen los virus hepatotropos actualmente conocidos, su epidemiología con referencia especial a los datos nacionales relativos a los virus A, B, C y E; su historia natural y sus aspectos clínicos más relevantes. Se enfatizan, además los diferentes marcadores virales serológicos, para el diagnóstico de infección aguda o crónica. Se incluyen también los diferentes tratamientos y las medidas de prevención (pasivas o activas) recomendadas actualmente

Tratamento de hepatites crônicas virais: uma atualização / Chronic viral hepatitis: an update

O autor realiza uma revisão da literatura sobre o tratamento atual das hepatites virais. Salienta, no caso da hepatite crônica pelo vírus B, a importância da vacinação, já que essa é uma doença que pode ser evitada. No seu tratamento, a droga mais aceita é o Interferon, a despeito da baixa eficácia. O papel dos análogos nucleosídios (lamivudina) ainda não está definido, restringindo-se o seu uso a protocolos, salvo em pacientes em programa de transplante hepático. No que tange ao tratamento da hepatite crônica pelo vírus C, a droga a ser ofertada também é o Inteferon. No entanto, pela baixa resposta terapêutica alcançada, abre-se uma perspectiva em sua associação com a Ribavirina

Picrorhiza kurroa (Kutaki) Royle ex Benth as a hepatoprotective agent--experimental & clinical studies.

Picrorhiza kurroa (Pk), a known hepatoprotective plant, was studied in experimental and clinical situtations. The standardization of active principles--Picroside 1 and 2 was done with High Performance Liquid Chromatography. Picroside 1 ranged from 2.72 to 2.88 mg/capsule and picroside 2 from 5.50 to 6.00 mg/capsule. In the galactosamine-induced liver injury in rats, Pk at a dose of 200 mg/kg p.o. showed a significant reduction (p < 0.05) in liver lipid content, GOT and GPT. In a randomised, double-blind placebo controlled trial in patients diagnosed to have acute viral hepatitis (HBsAg negative), Pk root powder 375 mg three times a day was given for 2 weeks (n = 15) or a matching placebo (n = 18) was given. Difference in values of bilirubin, SGOT and SGPT was significant between placebo and Pk groups. The time in days required for total serum bilirubin to drop to average value of 2.5 mg% was 75.9 days in placebo as against 27.44 days in Pk group. The present study has shown a biological plausability of efficacy of Pk as supported by clinical trial in viral hepatitis, hepatoprotection in animal model and an approach for standardizing extracts based on picroside content.

Interferons and liver disease

Interferons [INF] are naturally occurring peptides which have antiviral, antitumour and immunomodulatory properties. Interferons alpha, beta and Gamma constitute the main forms. INF alpha is administered by subcutaneous injection in doses ranging from 3 million units three times a week for 24 weeks in treatment of chronic hepatitis C to 5 million units daily for 16 weeks in treatment of chronic hepatitis B. However caution must be exercised before declaring IFN alpha a panacea for chronic viral hepatitis. For example, in chronic hepatitis C only 25% of cases demonstrate a biochemical improvement which is sustained through 6 months follow-up after completion of treatment. Some but not all biochemical responders will have an associated loss of hepatitis C virus. The presence of cirrhosis and/or high viral titres are poor prognostic indicators for biochemical response. It is unclear in HCV infection whether an absent or transient biochemical response would respond to higher doses or longer courses of INF or whether a sustained response is associated with reduced morbidity. Similary, in chronic HBV infection with evidence of active replication, INF may induce seroconversion [HBeAg converting to anti-HBe; loss of HBV DNA] in about 50% of cases and a sustained loss of HBsAg in 10-20% of cases during long-term follow-up. A large viral load, lack of inflammatory activity in the liver with near normal liver enzymes prior to treatment and positive anti-HIV are poor prognostic factors. It is unknown whether INF alpha alters mortality in chronic hepatitis B infection. The efficacy of INF alpha in chronic hepatitis due to mutant forms of HBV has not been studied adequately. INF alpha may be efficacious in some patients with HBV plus HDV infection. INF therapy may be limited by unwanted side effects including leucopenia, thrombocytopenia and malaise

Efectividad terapéutica de la S-Adenosil-L-Metionina en hepatitis viral aguda A,B, NANB

La hepatitis viral aguda es una causa frecuente de enfermedad en el mundo, ocasionado serias complicaciones, y altos costos como consecuencia de la incapacidad resultante. A pesar de esto, no disponemos de ninguna modalidad terapéutica de probada eficacia. El papel exacto de la SAMe en el tratamiento de las hepatopatías ha sido parcialmente clarificado por estudios recientes que muestran, que esta molécula es de efecto benéfico en la colestasis intrahepática (DRUGS 0:111, 1990) y otras hepatopatías. Para evaluar la efectividad de la SAMe se realizó un estudio doble ciego, placebo, control en 28 pacientes entre enero 25 de 1989 y junio 15 de 1991 con los siguientes criterios de inclusión: Edad entre 10 y 65 años, evidencia clínica de hepatitis aguda A, B o NANB, menos de 15 días de evolución, AST y-o ALT mayor de 500 U-L y bilirrubina total mayor de 3 mg-dl. Todos los pacientes fueron aleatorizados para recibir SAMe 500 mgr IV diariamente por 10 días o Placebo (l-Lisina 150 mg; Hidróxido de sodio 4.5 mgs; agua destilada estéril 5.0 ml) IV diariamente por 10 días. Ambos grupos eran comparables en relación con la edad, etiología y pruebas hepáticas. Las diferencias entre los grupos se evaluaron utilizando las pruebas ANOVA, t de Student, con programa estadístico SPSS-PC. Un valor de menos de 0.005 se consideró significativo

A double-blind clinical trial of kamalahar, an indigenous compound preparation, in acute viral hepatitis.

BACKGROUND: Kamalahar is an indigenous preparation reported to be beneficial in acute viral hepatitis. AIMS: To evaluate the efficacy of Kamalahain acute viral hepatitis in a double-blind, placebo-controlled study. METHODS: Fifty two patients with acute viral hepatitis were randomized to receive either Kamalahar 500 mg or a matched placebo three times a day for 15 days. Forty four patients (Kamalahar 20; placebo 24) completed the trial. RESULTS: Improvement in clinical signs was more marked with Kamalahar compared to placebo. The fall in serum bilirubin (p < 0.001), SGPT (p < 0.001) and serum alkaline phosphatase (p < 0.005) at day 15 was significantly greater with the drug. No significant side effects were observed. CONCLUSION: Kamalahar offers therapeutic promise in acute viral hepatitis.

Uso de interferon en hepatitis viral / Use of interferon in hepatitis viral

El autor hace una importante revisión sobre el uso del interferon alfa en las hepatitis "B" aguda y cronica, como también en la hepatitis "C" (NO-A NO-B). El esquema terapeutico en cada una de estas entidades, como su seguimiento clínico, laboratorial, histologico y con biopsia dirigida por laparoscopia