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GRUPO OTIMISMO DE APOIO AO PORTADOR DE HEPATITE
ONG - Registro n°.: 176.655 - RCPJ-RJ - CNPJ: 06.294.240/0001-22
Rio de Janeiro - RJ - Brasil
Tel.: (21) 9973.6832
e-mail: hepato@hepato.com Internet: www.hepato.com

06/04/2007


Qualidade de vida na hepatite C


Não existe qualquer questionamento ao fato comprovado que a hepatite C prejudica a qualidade de vida dos infectados. Um estudo publicado no Journal Of Viral Hepatology pesquisou se as pessoas com transaminases persistentemente normais apresentavam, também, uma menor qualidade de vida.

Foram acompanhados 165 pacientes infectados com hepatite C e, entre eles 70 possuem as transaminases elevadas de forma permanente, um grupo de 45 que apresentavam transaminases persistentemente normais e um grupo de 50 formado por indivíduos sadios, formando o chamado grupo controle.

Os grupos eram similares em relação à idade e sexo. No grupo de pacientes com hepatite C e transaminases elevada foi encontrado que predominava o sexo feminino e um maior tempo de infecção.

Por meio de um formulário denominado "Perfil do Estado Anímico" (POMS) foi determinado o estado emocional e psicológico de cada um dos participantes. A valorização da qualidade de vida foi avaliada por meio de um questionário sobre "Vida Cotidiana" (EDLQ), um método validado cientificamente que tem relação sobre pesquisas de saúde conhecidas como SF-36.

O resultado do estudo mostra que quando comparados ao grupo controle o grupo com hepatite C e transaminases normais apresentavam uma taxa de depressão mais alta e maior irritabilidade, junto com uma perda da auto-estima, vontade de viver, relação com o parceiro e autoconfiança.

Não foram observadas diferenças significativas entre os dois grupos com hepatite C (transaminases normais e transaminases elevadas), com exceção que o grupo com transaminases normais apresentou um grau de irritação superior ao grupo com transaminases elevadas.

Os autores declaram que não foi encontrada qualquer relação entre a qualidade de vida e a gravidade da doença hepática, concluindo que a diminuição da qualidade de vida em infectados com a hepatite C e similar nos pacientes com transaminases normais ou elevadas.

MEU COMENTÁRIO:

O estudo e de tal importância para que os médicos, psicólogos e psiquiatras compreendam melhor os sentimentos de um infectado pela hepatite C que ao final deste, após o texto em espanhol, colocamos o artigo original completo (em Inglês).

Uma outra observação importante no estudo é que não são encontrados sinais tão evidentes de deterioração da qualidade de vida nos infectados pela hepatite B.

Este artigo foi redigido com comentários e interpretação pessoal de seu autor, tomando como base a seguinte fonte:
J Viral Hepat 2006 Dec; 13:828-34 - Impaired health-related quality of life in patients with chronic hepatitis C and persistently normal aminotransferase levels - M. von Wagner; J.-H. Lee - Klinik für Innere Medizin II, Universitätsklinikum des Saarlandes, Homburg, Saar, Germany and Medizinische Klinik I, Johann Wolfgang Goethe-Universität, Frankfurt, Germany


Carlos Varaldo
Grupo Otimismo






GRUPO OPTIMISMO DE AYUDA AL PORTADOR DE HEPATITIS
ONG - Registro n°.: 176.655 - RCPJ-RJ - CNPJ: 06.294.240/0001-22
Rio de Janeiro - Brasil
Tel. (55.21) - 9973.6832
e-mail: hepato@hepato.com Internet: www.hepato.com
06/04/2007


Calidad de vida en la Hepatitis C


No existe cualquier cuestionamiento al hecho comprobado que la Hepatitis C perjudica la calidad de vida de los infectados. Un estudio publicado en el Journal Of Viral Hepatology investigó si las personas con transaminasas persistentemente normales presentaban, también, una menor calidad de vida.

Fueron acompañados 165 pacientes infectados con Hepatitis C y, entre ellos 70 con las transaminasas elevadas de forma permanente, un grupo de 45 que presentaban transaminasas persistentemente normales y un grupo de 50 constituido por individuos sanos, formando el llamado grupo control.

Los grupos eran similares con relación a la edad y sexo. En el grupo de pacientes con Hepatitis C y transaminasas elevadas fue encontrado que predominaba el sexo femenino y un mayor tiempo de infección.

Por medio de un formulario denominado "Perfil del Estado Anímico" (POMS) fue determinado el estado emocional y psicológico de cada uno de los participantes. La valorización de la calidad de vida fue evaluada por medio de un cuestionario sobre "Vida Cotidiana" (EDLQ), un método validado científicamente que tiene relación sobre investigaciones de salud conocidas como SF-36.

El resultado del estudio muestra que cuando comparados al grupo control el grupo con Hepatitis C y transaminasas normales presentaban una tasa de depresión más alta y mayor irritabilidad, junto con una pérdida de la autoestima, voluntad de vivir, relación con el compañero y auto confianza.

No fueron observadas diferencias significativas entre los dos grupos con Hepatitis C (transaminasas normales y transaminasas elevadas), aparte que el grupo con transaminasas normales presentó un grado de irritación superior al grupo con transaminasas elevadas.

Los autores declaran que no fue encontrada cualquier relación entre la calidad de vida y la gravedad de la enfermedad hepática, concluyendo que la disminución de la calidad de vida en infectados con a Hepatitis C es similar en los pacientes con transaminasas normales o elevadas.

MI COMENTARIO:

El estudio es de tal importancia para que los médicos, psicólogos y psiquiatras comprendan mejor los sentimientos de un infectado por la Hepatitis C que al final de este colocamos el artículo completo (en inglés).

Otra observación importante en el estudio es que no son encontradas señales tan evidentes de deterioro de la calidad de vida nos infectados por la hepatitis B.

Este artículo fue redactado con comentarios e interpretación personal de su autor, tomando como base la siguiente fuente:
J Viral Hepat 2006 Dec; 13:828-34 - Impaired health-related quality of life in patients with chronic hepatitis C and persistently normal aminotransferase levels - M. von Wagner; J.-H. Lee - Klinik für Innere Medizin II, Universitätsklinikum des Saarlandes, Homburg, Saar, Germany and Medizinische Klinik I, Johann Wolfgang Goethe-Universität, Frankfurt, Germany


Carlos Varaldo
Grupo Optimismo




Impaired Health-Related Quality of Life in Patients With Chronic Hepatitis C and Persistently Normal Aminotransferase Levels


M. von Wagner1; J.-H. Lee2 Summary and Introduction

Summary


A significant impact of hepatitis C virus (HCV) infection on health-related quality of life (HRQOL) has been previously described. However, comprehensive data on the quality of life in patients with chronic hepatitis C and persistently normal aminotransferase levels (PNAL) are currently not available. One hundred fifteen patients with chronic hepatitis C (45 with persistently normal aminotransferases and 70 with elevated aminotransferases) and 50 healthy subjects were enrolled. Emotional and psychological states were assessed by Profile of Mood States (POMS) scale and HRQOL was assessed by the 'Everyday Life' questionnaire (EDLQ), a validated questionnaire related to the SF-36 Health Survey. An impairment in HRQOL was observed in patients with chronic hepatitis C showing PNAL compared with healthy subjects with significant differences for the factor scores depression and anger in the POMS scale as well as for the items body, relationship to partner, self-confidence and zest of life in the EDLQ. No differences in any questionnaire were observed between patients with chronic hepatitis C showing PNAL or elevated aminotransferase levels except of a worse mean level for factor score anger in POMS scale in patients with persistently normal aminotransferases. No association of quality of life with severity of liver disease was found. Impairment of HRQOL by chronic infection with HCV is similar in patients with PNAL and those with elevated aminotransferase levels.

Introduction

Besides the risk to develop liver cirrhosis and its sequelae, chronic infection with hepatitis C virus (HCV) impairs health-related quality of life (HRQOL) similar to that in patients with diabetes mellitus or chronic polyarthritis and more distinctive than in patients with chronic hepatitis B.[1-4] Patients who achieved sustained virological response following antiviral treatment with interferon alpha and ribavirin showed a significant improvement in HRQOL.[2,5-8]

Up to 46% of patients with chronic hepatitis C show persistently normal aminotransferase levels (PNAL) associated with a lower inflammatory activity, hepatocellular proliferation rate and slower fibrosis progression in the liver.[9-13] However, no data are yet available for HRQOL in these patients. In the present prospective study, we compared HRQOL in patients with chronic hepatitis C and PNAL with that in patients with chronic hepatitis C and elevated aminotransferases as well as with HRQOL in healthy subjects.

Patients and Methods

Patients

One hundred fifteen patients (52 males, 63 females; mean age 43.0 ± 13.1 years.) with chronic hepatitis C were enrolled within the outpatient clinic at the University hospital in Frankfurt/Main. The diagnosis of chronic hepatitis C was based on the detection of anti-HCV antibodies by third generation enzyme immunoassay and consistent detection of HCV RNA for at least 6 months. All were negative for the hepatitis B surface antigen and antibodies for the human immunodeficiency virus types 1 and 2 and showed no evidence for other liver diseases (e.g. autoimmune hepatitis, haemochromatosis). None of the patients were previously treated with interferon alpha. All participants signed an informed consent that was approved by the local ethical committee for Medical Research in accordance with the 1975 Declaration of Helsinki.

Of 115 patients, 45 (39%) with chronic hepatitis C showed PNAL, defined as an alanine aminotransferase (ALT) activity equal to or below the upper limit of normal (ULN), documented on at least three occasions during a 6-month period, a minimum of 4 weeks apart, 70 patients with chronic hepatitis C showed elevated aminotransferase levels on at least two occasions during a 6-months period. Estimated duration of infection was based on risk factor assessment and history of exposure. Fifty healthy subjects without any evidence for acute or chronic disease served as control group for the quality of life assessment. Healthy subjects and patients with chronic hepatitis C and PNAL were similar with respect to age and gender. Genotyping of HCV (according to the classification of Simmonds et al.[14]) was performed by reverse hybridization assay (INNO LiPA HCV II; Innogenetics, Gent, Belgium). Quantification of HCV RNA was performed using a reverse transcriptase-polymerase chain reaction assay (Amplicor Monitor® HCV Test v 2.0; Roche Diagnostic Systems, Mannheim, Germany).

In 27 of 45 patients with chronic hepatitis C and PNAL and in 68 of 70 patients with chronic hepatitis C and elevated aminotransferase levels, a percutaneous liver biopsy was performed. Liver biopsy was evaluated according to the histology activity index (HAI).[15] Progression of liver fibrosis was calculated by division of the liver fibrosis score and the estimated duration of infection, which was based on risk factor assessment and history of exposure.[16]

Definition of Normal Ranges for Serum Alanine Aminotransferase

Routine parameters including ALT, aspartate aminotransferase, gamma-glutamyl transferase levels (GGT) were measured in the local laboratory. The ULN for ALT was 23 U/L in male and 19 U/L in female patients. However, current definitions of normal ranges for serum ALT levels fail to identify many patients with hepatic injury. Prati et al.[17] recently defined 0.75 times the standard ULN for male and 0.63 times the standard ULN for female patients as an updated 'healthy' ULN for ALT. According to the reference ranges in our local laboratory, a healthy ULN for ALT refers to 17 U/L and 12 U/L for male and female patients, respectively.

Instruments Used for Assessment of Health-related Quality of Life

Emotional and psychological states were measured by a German-adapted and -validated Profile of Mood States (POMS) scale that measures factor scores depression, fatigue, vigour and anger.[18,19] Furthermore, quality of life was assessed by the 'Everyday Life' questionnaire (EDLQ), a German-validated questionnaire related to the SF-36 Health Survey, at the same time.[20,21] The EDLQ assesses the following four subscales of the HRQOL: body and health (e.g. make demands on body, concentrate on a task), everyday life (e.g. solve daily problems, perform personal hygiene), social activity (e.g. get along with family, count on partner's help) and zest of life (e.g. enjoy life). For every patient, a sum score of all items of the subscales was used; missing items were replaced by the mean of the nonmissing items of the subscale. However, missing questionnaires were not replaced. For the items 'relationship to partner' and 'social binding' as well as for the sum score, only patients who were living in a partnership were taken into consideration.

Statistical Analysis

Data are presented as mean ± SD or median ± range as appropriate. Statistical significance was assessed by Fisher's exact test and Mann-Whitney U-test. For HRQOL analysis, differences were tested by Wilcoxon rank sum test.

Results

Baseline Characteristics


Clinical, biochemical and virological characteristics of patients with chronic hepatitis C and healthy subjects are shown. Significant differences between the groups of patients with chronic hepatitis C and PNAL and those with elevated aminotransferase levels were found for the proportion of male patients (35%vs 65%; P = 0.001), GGT (16.0 U/L vs 33.5U/L; P = 0.001) and estimated duration of infection (176.9 months vs 131.2 months; P = 0.02). GGT levels were elevated in 14/41 patients with PNAL (males 3/15; females 11/26). In liver histology, a significantly higher inflammatory activity (4.89 ± 1.95 vs 3.88 ± 1.63; P up to 0.02) as well as a higher estimated fibrosis progression rate (0.47 ± 0.74 vs 0.2 ± 0.29; P low to 0.05) was observed in the group of patients with elevated aminotransferase levels compared with the group of patients with PNAL. However, no differences were observed for the mean fibrosis score (2.01 ± 1.22 vs 2.13 ± 1.22; P = NS) and the proportion of patients with bridging fibrosis (C) or cirrhosis (D) between both groups (C: 41%vs 44%, D: 12%vs 7%; P = NS)

The control group of 50 healthy subjects was similar in age and gender to the group of patients with chronic hepatitis C and PNAL and did not show any evidence for an acute or chronic disease.

Assessment of Quality of Life


Profile of Mood States Scale. Current mood and psychological states were measured using a German-adapted and -validated POMS scale. Differences between patients with chronic hepatitis C and PNAL and healthy subjects were found in all four factor scores (depression, fatigue, vigour and anger) revealing worse mean levels for patients with chronic hepatitis C and PNAL. Differences achieved statistically significant differences for the factors depression (P = 0.006) and anger (P = 0.007). In comparison to patients with chronic hepatitis C and elevated aminotransferase levels in patients with PNAL, a significantly worse mean level for anger (7.1 vs 4.75; P = 02) was observed, while no differences were found for depression, fatigue, and vigour.

Currently, the ULN for aminotransferase levels are discussed and new limits have been suggested as updated healthy ULN levels for ALT.[17] Therefore, a subanalysis was performed for patients showing healthy ALT levels. Eleven patients with chronic hepatitis C showed healthy ALT levels (males = 7). However, the items depression and anger remained significantly worse in the subgroup of patients with chronic hepatitis C and healthy ALT levels compared with the group of healthy subjects (data not shown).

Everyday Life Questionnaire. Using the EDLQ, a German-validated questionnaire related to the SF-36 Health Survey, 10 items were analysed and summarized in four subscales (body and health, everyday life, social activity and zest of life) for assessment of the HRQOL. In addition, a sum score of all items was calculated for the overall HRQOL .

In patients with chronic hepatitis C and persistently normal aminotransferases, lower mean levels were found in all four subscales compared with healthy control subjects. Differences achieved statistical significance in the items body (8.71 vs 9.7; P = 0.04), relationship to partner (8.0 vs 9.6; P = 0.01), self-confidence (8.6 vs 9.7; P = 0.01) and zest of life (9.0 vs 10.0; P = 0.03). However, comparing patients with chronic hepatitis C with PNAL and those with elevated aminotransferase levels, no differences were observed in any item, subscale or the sum score.

In addition, a subanalysis for patients with chronic hepatitis C and healthy ALT levels in comparison with healthy subjects was performed. HCV-infected patients with healthy ALT levels also showed lower mean levels in all items with statistically significant differences in the items relationship to partner, self-fulfillment, enjoyment of life and zest of life.

Because of a significantly higher number of female patients in the group of patients with chronic hepatitis C and PNAL, gender-specific subanalyses for the POMS and the EDLQ were performed. However, results remained similar. POMS and EDLQ were also compared between patients with severe fibrosis (HAI IV stage C and D) and patients with lower fibrosis levels. As in the general analysis no significant impact of the fibrosis stage on HRQOL was observed. Statistical significant differences were also independent of alcohol consumption, aminotransferase levels, GGT, stage of fibrosis, viral load and HCV genotype (data not shown).

Discussion

Previously, the impact of chronic hepatitis C on HRQOL was found to be independent of the severity of liver damage.[1-3,22] However, for patients chronically infected with HCV who show PNAL, no data are available on the impact of chronic hepatitis C on HRQOL.

In the present prospective study, patients with chronic hepatitis C and PNAL showed an impairment in HRQOL expressed by worse mean levels in all four factor scores of the POMS scale as well as lower mean levels in all four subscales and the sum score of the EDLQ compared with a control group of healthy subjects. According to the POMS scale, which investigates mood and psychological states of the past 4 weeks, patients with chronic hepatitis C and PNAL were significantly more depressed and angry than healthy subjects. In the EDLQ, statistically significant lower mean levels were found for the items body, relationship to partner, self-confidence and zest of life in patients with chronic hepatitis C and PNAL compared with healthy subjects. In contrast, no differences were found between patients with chronic hepatitis C and PNAL and those with chronic hepatitis C and elevated aminotransferase levels in both questionnaires. In the POMS, an even significantly worse mean level was found for the factor anger in patients with PNAL compared with those with elevated aminotransferase levels. All results were confirmed in a gender-specific subanalysis and were independent of alcohol consumption, HCV RNA serum concentration and HCV genotype.

In accordance with previous studies, inflammatory activity and fibrosis progression rate in the liver were found to be significantly lower for patients with chronic hepatitis C and PNAL compared with the group of patients with elevated aminotransferase levels. However, reduction in HRQOL in patients with chronic hepatitis C was found to be independent of aminotransferase levels and the stage of liver disease.[1,23-28]

The ULN for aminotransferase levels are currently under discussion because aminotransferase activity as a screening parameter fails to identify a significant proportion of the patients with chronic hepatitis C. Prati et al.[17] recently published a large analysis of ALT levels and suggested lower ULN. In the present study, 11 patients with chronic hepatitis C and PNAL had low normal ALT levels (healthy ALT levels). However, in this subgroup of patients with healthy ALT levels, the results in POMS scale and EDLQ were similar to the results observed in the whole group of patients with PNAL.

In our tertiary referral centre, all patients with chronic hepatitis C were informed about their diagnosis at the time they completed the questionnaires. In one recent study, no impact of chronic hepatitis C on HRQOL was observed in patients who were not yet aware of their chronic infection.[29] In addition, in a population of active injection drug users, a reduction in HRQOL was shown to be independent of the actual HCV infection status of a patient, however, subjects believing to be infected by HCV scored significantly worse compared with those who did not.[30] Thus, knowledge of chronic HCV infection may have significant impact on the quality of life. However, there is an increasing evidence (e.g. proton magnetic resonance spectroscopy, neurophysiological studies, detection of negative strand HCV RNA in liquor and postmortem brain tissue) that intracerebral HCV infection and/or biological mechanisms may underlie neuropsychological and cognitive findings.[31-34]

In conclusion, chronic hepatitis C has a significant impact on HRQOL not only in patients with elevated ALT levels but also in patients with PNAL. Therefore, in accordance with a recently published randomized clinical trial,[35] the decision for treatment in patients with chronic hepatitis C and PNAL should be individualized taking quality of life into account.

This work was presented in part at the annual meeting of the American Association for the Study of Liver Diseases, Boston, MA, USA on October 2003. Informed consent was obtained from each patient and the study was approved by the Ethics Committee for Medical Research in Frankfurt in accordance with the 1975 declaration of Helsinki.





Last updated 6.4.2007