الفهرس 
Hepatitis C virus (HCV)Only 14 pages are availabe for public view
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Abstract
Hepatitis C virus (HCV) is a leading cause of liver cirrhosis and cancer in the world. Egypt has the highest HCV prevalence which is the leading cause of chronic hepatitis C in the country. This chronic infection can be treated with medication; the standard therapy is a combination of Pegylated interferon alpha plus ribavirin (PEG-INF/RBV).
The aim of the present work was to study the treatment response of PEG-INF/RBV combination therapy and the health related quality of life (HRQOL) of CHC patients at Gamal Abd El-Naser Hospital, Alexandria. The study comprised the following objectives:
4. To investigate the response of chronic hepatitis C (CHC) patients to the scheduled standardized treatment PEG-INF/RBV combination therapy.
5. To assess factors that could predict the response of CHC patients to the treatment.
6. To assess the health related quality of life of CHC patients before, during and after PEG-INF/RBV combination therapy.
Subjects and Methods:
An interventional study (one group pretest- post test design) was used. The study was conducted in the Hepatology and Interferon Therapy Unit at Gamal Abd El Naser Insurance Hospital in Alexandria. The target population were CHC patients registered at this unit. Three hundred patients were included in the study.
The data collection methods and tools included:
2. Data collection sheet was prepared to collect information about CHC patients. It included the following sections:
Section (1):
c) Socio-demographic characteristics including age, gender, residence, marital status, level of education, occupation, and family size.
d) Medical history of chronic diseases as diabetes mellitus and cardiovascular diseases.
These data were collected using a pre-designed structured interviewing questionnaire.
Section (2): Patients‘medical records review:
A record review sheet was prepared to record the medical history and the laboratory investigations of patients including haemoglobin level, liver enzymes (AST, ALT), Bilirubin, HCV RNA level by Polymerase Chain Reaction (PCR) and Thyroid stimulating hormone (TSH). These investigations are routinely conducted for the patients at the hospital.Haemoglobin level, liver enzymes (AST, ALT) and Bilirubin were recorded before administration of the combined therapy and at 4, 12, 24, 48 weeks. HCV RNA level by PCR and TSH were recorded before administration of the combined therapy, and at 12, 24 and 48 weeks
Section (3): Viral hepatitis C quality of life questionnaire:
Summary
64
The viral hepatitis C quality of life questionnaire was previously validated and based on a core set of generic health measures. This questionnaire included:
The generic form of SF-36 which was developed from a medical outcomes study in 1980 and undertaken by the Rand Corporation to evaluate on alternative method of financing healthcare in the USA.
Measures of concepts thought to characterize the experience of living with
CHC (sleep disturbance, sexual problems, and financial burdens).
The SF- 36 has 36 items and consists of eight multi- items variables (domains): Physical functioning (10 items), social functioning (2 items), role limitation due to emotional problems ( 3 items), role limitation due to physical health problems (4 items), emotional well- being (5 items), energy and vitality (4 items), pain (2items), general perception of health (5 items), and another single item which solicits a self assessment of health change over the past year.
2. Intervention:
Chronic hepatitis C patients were interviewed at baseline, 4, 12, 24 and 48 weeks (during the treatment sessions) to assess the treatment response and their health related quality of life before, during and after the treatment.
Mantel-Haenszel Chi-square was used as tests of significance. The 5% level was used as a cut off value for statistical significance. Multivariate analysis of variance (MANOVA) was used to explore the impact of personal and socio-demographic aspects of CHC patients on their HRQOL. Multivariate logistic regression analysis was used to assess predictors of seroconversion among CHC patients and the relationship between these predictors and the HRQOL. Survival analysis was used to assess the differences between predictor variables affecting cumulative survival of seronegativity among treated CHC patients.
Results:
The results of the present study could be classified into the following items:
V. Response of CHC patients to the standardized treatment schedule of PEG-INF/RBV combination therapy: The EVR of patients at the 12th week of treatment was 92%, while 88.4% remained HCV RNA negative at the 24th week of treatment. Almost all patients who achieved virologic response at the 24th week had ETR.
The proportion of patients who survived seronegativity was 0.270 at the 12 th week, 0.261 at the 24th week and to 0.250 at the 48 th week of treatment.
The proportion of patients who survived seronegativity was 0.118 for those below 55 years and 0.624 for patients 55 years and above at the 48 th week of treatment with a statistically signeficant difference (X2 = 88.26, p= 0.000).
As for the viral load, the proportion of patients who survived seronegativity was 0.021 for a HC viral load below 900,000 IU/ml and 0.859 for CHC treated patients of a HC viral load of ≥ 900,000 IU/ml at the 48 th week of treatment with a statisically significant difference (X2 = 219.07, P= 0.000).
Summary
65
At the 12th week of treatment, about half of patients (52%) had mild anemia and 13.7% had moderate anemia. Only 23.3% and 3.6% of patients had mild and moderate anemia respectively at the 48th week of treatment.
Baseline tests showed that thyroid stimulating hormone (TSH) was normal while at the 48th week of treatment, more than one eighth of patients (16.4%) had high TSH and 6.6% had low TSH.
At baseline, more than one fifth of patients (21.3%) had hyperbilirubinemia and elevated liver enzymes (AST, ALT), while the percent were only 9.01%, 0.8% and 0.4%, respectively at the 48th week of treatment.
VI. Factors affecting treatment response of CHC patients:
Patients aged 55 years and above had a significantly higher seropostivity compared to those below 55 years of age (cOR = 15.5, 95% CI = 8.256 - 29.118, X2MH = 88.035, p = 0.000).
Females had a significantly higher seronegativity compared to males (cOR = 0.538, 95% CI = 0.290 – 0.997, X2MH = 3.956, p = 0.049).
Patients with university level of education were seronegative compared to those with primary, preparatory and secondary level of education. However, this difference was not significant.
Patients who were living in Matrouh had higher seronegativity compared to those of Alexandria and Behira residents. This difference was not statistically significant.
Patients who were singles had higher seronegativity compared to those who were ever married. However, this association was not significant.
Patients who were professionals and skilled workers had a significantly higher seronegativity compared to those with other occupations (cOR = 5.20, 95% CI = 2.96 – 9.13, X2MH = 36.150, p = 0.000).
Patients who had family size up to 4 were seronegative by end of follow up at the 48th week compared to those who had family size more than 4 with a statistically insignificant difference.
A significant relationship was detected between presence of chronic diseases and treatment response. Patients who were free of chronic diseases had significantly higher seronegativity at the end of follow up compared to those with other diseases (X2MH = 59.859, p = 0.000).
With regard to HC viral load, significant difference was found between the HC viral load and the treatment response. Patients with a viral load less than 900,000 IU/ml were more seronegative by end of follow up at the 48th week compared to those with ≥ 900.000 IU/ml HC viral load (cOR = 210.0, 95% CI = 76.038 – 579.976, X2MH = 211.226, p = 0.000).Haemoglobin level, liver enzymes (AST, ALT) and Bilirubin were recorded before administration of the combined therapy and at 4, 12, 24, 48 weeks. HCV RNA level by PCR and TSH were recorded before administration of the combined therapy, and at 12, 24 and 48 weeks
Section (3): Viral hepatitis C quality of life questionnaire:
Summary
64
The viral hepatitis C quality of life questionnaire was previously validated and based on a core set of generic health measures. This questionnaire included:
The generic form of SF-36 which was developed from a medical outcomes study in 1980 and undertaken by the Rand Corporation to evaluate on alternative method of financing healthcare in the USA.
Measures of concepts thought to characterize the experience of living with
CHC (sleep disturbance, sexual problems, and financial burdens).
The SF- 36 has 36 items and consists of eight multi- items variables (domains): Physical functioning (10 items), social functioning (2 items), role limitation due to emotional problems ( 3 items), role limitation due to physical health problems (4 items), emotional well- being (5 items), energy and vitality (4 items), pain (2items), general perception of health (5 items), and another single item which solicits a self assessment of health change over the past year.
2. Intervention:
Chronic hepatitis C patients were interviewed at baseline, 4, 12, 24 and 48 weeks (during the treatment sessions) to assess the treatment response and their health related quality of life before, during and after the treatment.
Mantel-Haenszel Chi-square was used as tests of significance. The 5% level was used as a cut off value for statistical significance. Multivariate analysis of variance (MANOVA) was used to explore the impact of personal and socio-demographic aspects of CHC patients on their HRQOL. Multivariate logistic regression analysis was used to assess predictors of seroconversion among CHC patients and the relationship between these predictors and the HRQOL. Survival analysis was used to assess the differences between predictor variables affecting cumulative survival of seronegativity among treated CHC patients.
Results:
The results of the present study could be classified into the following items:
V. Response of CHC patients to the standardized treatment schedule of PEG-INF/RBV combination therapy: The EVR of patients at the 12th week of treatment was 92%, while 88.4% remained HCV RNA negative at the 24th week of treatment. Almost all patients who achieved virologic response at the 24th week had ETR.
The proportion of patients who survived seronegativity was 0.270 at the 12 th week, 0.261 at the 24th week and to 0.250 at the 48 th week of treatment.
The proportion of patients who survived seronegativity was 0.118 for those below 55 years and 0.624 for patients 55 years and above at the 48 th week of treatment with a statistically signeficant difference (X2 = 88.26, p= 0.000).
As for the viral load, the proportion of patients who survived seronegativity was 0.021 for a HC viral load below 900,000 IU/ml and 0.859 for CHC treated patients of a HC viral load of ≥ 900,000 IU/ml at the 48 th week of treatment with a statisically significant difference (X2 = 219.07, P= 0.000).
Summary
65
At the 12th week of treatment, about half of patients (52%) had mild anemia and 13.7% had moderate anemia. Only 23.3% and 3.6% of patients had mild and moderate anemia respectively at the 48th week of treatment.
Baseline tests showed that thyroid stimulating hormone (TSH) was normal while at the 48th week of treatment, more than one eighth of patients (16.4%) had high TSH and 6.6% had low TSH.
At baseline, more than one fifth of patients (21.3%) had hyperbilirubinemia and elevated liver enzymes (AST, ALT), while the percent were only 9.01%, 0.8% and 0.4%, respectively at the 48th week of treatment.
VI. Factors affecting treatment response of CHC patients:
Patients aged 55 years and above had a significantly higher seropostivity compared to those below 55 years of age (cOR = 15.5, 95% CI = 8.256 - 29.118, X2MH = 88.035, p = 0.000).
Females had a significantly higher seronegativity compared to males (cOR = 0.538, 95% CI = 0.290 – 0.997, X2MH = 3.956, p = 0.049).
Patients with university level of education were seronegative compared to those with primary, preparatory and secondary level of education. However, this difference was not significant.
Patients who were living in Matrouh had higher seronegativity compared to those of Alexandria and Behira residents. This difference was not statistically significant.
Patients who were singles had higher seronegativity compared to those who were ever married. However, this association was not significant.
Patients who were professionals and skilled workers had a significantly higher seronegativity compared to those with other occupations (cOR = 5.20, 95% CI = 2.96 – 9.13, X2MH = 36.150, p = 0.000).
Patients who had family size up to 4 were seronegative by end of follow up at the 48th week compared to those who had family size more than 4 with a statistically insignificant difference.
A significant relationship was detected between presence of chronic diseases and treatment response. Patients who were free of chronic diseases had significantly higher seronegativity at the end of follow up compared to those with other diseases (X2MH = 59.859, p = 0.000).
With regard to HC viral load, significant difference was found between the HC viral load and the treatment response. Patients with a viral load less than 900,000 IU/ml were more seronegative by end of follow up at the 48th week compared to those with ≥ 900.000 IU/ml HC viral load (cOR = 210.0, 95% CI = 76.038 – 579.976, X2MH = 211.226, p = 0.000).