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Health-related quality of life in children with

chronic hepatitis C

Ola Galal Ali Behairy

Department of Pediatrics, Faculty of Medicine, Benha University, Egypt Received 20 February 2016; revised 20 May 2016; accepted 7 August 2016 Available online 21 August 2016

KEYWORDS Pegylated interferon; Children; Hepatitis C; Depression; Quality of life

Abstract Background: Mood disturbances, including depression, are relatively common in the hepatitis C virus-infected population and may worsen during hepatitis C treatment, also hepatitis C virus infection is associated with decreased quality of life (QOL) and neurocognitive dysfunction in adults, but little is known about its impact on children.

Aim of the study: To assess the health-related quality of life (HRQOL), behavioral/emotional func-tioning, and cognitive status of children with hepatitis C infection with and without treatment. Methods: A total of 120 children who were divided into three groups: group 1: 30 chronic hepatitis C infected children without treatment, group II: 30 chronic hepatitis C infected children under treat-ment with peg-interferon and ribavirin, group III: Includes 60 normal children matched for age and sex as a control group were enrolled in this case–control study. We used the Peds QLTM 4.0 generic score scale to assess the HRQOL based on a child’s self- and parent proxy reports. Also assessment of childhood depression using ACDS Inventory, Arabic form based on Kovacs Children’s Depres-sion Inventory was done.

Results: There was a statistical significant difference between studied groups regarding physical, emotional, social and school functioning parameter of parents’ reports and child opinion of PEDSQL score, also there was a statistical significant difference between studied groups regarding depression score as it was significantly higher in group II (hepatitis C infected children under treat-ment with peg-interferon and ribavirin).

Conclusion: HRQOL and depression scores were significantly increased in children with chronic hepatitis C however both were higher in children receiving treatment.

Ó 2016 The Egyptian Pediatric Association. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Introduction

Hepatitis C virus (HCV) infection is a serious health problem worldwide that establishes a chronic infection in up to 85% of cases.1Estimates of prevalence range from less than 1.0% in

northern Europe to more than 2.9% in northern Africa.2 Many publications suggest that over 15% of the people in Egypt are infected. This is ten times greater than in any other country in the world. The prevalence of HCV varies through-out the country. The available data suggests that the northern Nile Delta has the highest prevalence,28%. The much smal-ler population of upper Egypt, in the south, has a slightly lower HCV prevalence, 20%. The two major urban centers, Peer review under responsibility of Egyptian Pediatric Association

Gazette.

H O S T E D BY Contents lists available atScienceDirect

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http://dx.doi.org/10.1016/j.epag.2016.08.001

1110-6638Ó 2016 The Egyptian Pediatric Association. Production and hosting by Elsevier B.V.

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Cairo and Alexandria, have the lowest prevalence of9% and 6%, respectively.3Studies of the magnitude of HCV infec-tion in Egyptian children revealed a prevalence of 3% in upper Egypt and 9% in lower Egypt.4. The course of HCV infection in children is generally more benign than that seen in adults, approximately 30 percent of infected children will develop symptomatic or progressive disease and be at risk for cirrhosis and hepatocellular carcinoma later in life. However, there is emerging evidence that chronic HCV treatment in children and adolescents can yield virologic results comparable to, or even better than, those in adults.5HCV infection is associated with psychiatric symptoms like depression. Together with other factors (e.g. the severity of hepatic condition), two lines of evidence support an association between HCV and depres-sion. First: patient with psychiatric disorder have higher preva-lence of HCV infection. Second: patient with chronic hepatitis may have higher prevalence of psychiatric disorder including depression.6 Antiviral treatment of HCV with IFN-alpha is associated with severe neuropsychiatric side effect such as psy-chosis, depression and neuropsychological dysfunction these symptoms can lead to poor compliance and the need to decrease or prematurely stop antiviral therapy.7 Health-related quality of life (HRQOL) is a concept that relates to an individual’s perception of health status in relation to the culture and value systems in which they live, in addition to their expectations, goals, concerns, and living standards. The chronic HCV literature is replete with findings of quality of life (QOL), psychological, and cognitive deficits in treatment-naı¨ve adults as well as those receiving interferon and ribavirin ther-apy. However, comparatively less is known about how HCV and its treatment affect these clinical parameters in children.8 While QOL is emerging as an important endpoint in pediatric clinical trials of HCV treatments, there is a paucity of data on other patient-oriented outcomes that are pertinent to child development and function. The inclusion of patient-oriented outcomes such as behavioral adaptation, depression, anxiety, and cognitive functioning in HCV pediatric clinical trials is important for several reasons. The impact of HCV treatments on these parameters in children is not presently known and such information will allow health professionals to better inform patients and their parents about the range of possible side effects. Also, identifying the complete range of morbidity associated with chronic HCV and its treatments may facilitate the development and implementation of psychotherapeutic or psychopharmacological interventions aimed at attenuating morbidity in these children.9

Subjects and methods

This was a prospective case–control study approved by the ethics committee of Benha University. Patients and their par-ents were informed of the purpose of the current trial and they signed informed consent forms before their enrollment. A total of 120 children, 60 chronic hepatitis C who were selected from Pediatric Hepatology department, National Liver Institute, Pediatric Hepatology clinic, Benha University hospitals and 60 healthy children selected from general population (aged 8–17 years) in the period from August 2009 to October 2013. They were divided into three groups: Group 1: Included 30 chronic hepatitis C infected children without treatment, Group II: Included 30 chronic hepatitis C infected children in the

per-iod between 12 to 24 weeks of starting treatment with peg-interferon and ribavirin. Group III: Included 60 normal chil-dren as a control group. Inclusion criteria for group I & II: Age618 years, positive anti-HCV antibody, detectable serum HCV-RNA, liver biopsy showing chronic hepatitis with evi-dence of fibrosis, compensated liver disease (Child-Pugh Grade A clinical classification). Exclusion criteria: Other causes of acute or chronic hepatitis, liver cirrhosis, autoimmune hepati-tis, positive HbsAg and known hypersensitivity to peg-IFN and ribavirin.

Methodology

Files of the patients were examined and the following data were retrieved: history, clinical examination, abdominal ultra-sonography, result of liver needle biopsy, Viral markers (HCV Ab and HbsAg), complete blood picture (CBC), liver function tests: [ALT, AST and serum bilirubin (total and direct)] and serum creatinine. Psychological and behavioral assessment was done by the current HRQOL questionnaire in pediatrics that was designed by the World Health Organization (WHO) and consisted of the 23-item HRQOL generic core scales for children and teens aged 2 to 18 years old.10An Arabic trans-lated questionnaire was used based on The Peds QLTM 4.0 generic core scale which is a 23-item questionnaire of self and proxy reports consisting of 4 scales to evaluate physical, emotional, social, and academic functioning.11 A 5-point response scale ranges from 0 (never a problem) to 4 (almost always a problem). All questions are addressed twice, once for patients and once for parents, our participants were aged between 8 and 17 years and if the child or teen was unable to complete the self-report forms, the study administrator read a questionnaire aloud for them and avoided suggesting a speci-fic answer by avoiding intonation change. Parents self-administered the PedsQLTM 4.0 after a brief instruction from the administrator. Assessment of childhood depression for our patients using ACDS Inventory, Arabic form12 based on Kovacs Children’s Depression Inventory.13 The Children’s Depression Inventory (CDI) was completed by the child and it assessed cognitive and behavioral symptoms of depression. A total scoreP12 is indicative of possible clinical depression. Statistical analysis

Data were tabulated, coded then analyzed using the computer program SPSS (statistical package for social science) version 16. Quantitative data were presented as mean ± SD. Student’s t-test was used to compare between two groups. Pearson’s cor-relation coefficient was used to test corcor-relation between vari-ables and chi-square test was used to compare frequency of qualitative variables among the different groups. For all anal-yses, the level of significance was set at p < 0.05.

Results

This study included a total of 120 subjects; group I: 30 patients with chronic hepatitis C without treatment [18 males (60%) and 12 females (40%)], group II: 30 patients with chronic hep-atitis C treated with peg-interferon and ribavirin [15 males (50%) and 15 females (50%)] and group III: 60 subjects were

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considered as a control group [23 males (38.3%) and 37 females (61.7%)]. There was no statistical significant difference between studied groups regarding sex and age (Table 1). There was a statistical significant difference between studied groups regarding physical and emotional parameter of parents’ reports of PEDSQL score as they were higher in HCV treated cases (group II) (Mean = 18.03 ± 4.62) & (Mean = 14.67 ± 2.51) respectively (Table 2). There was a statistical signifi-cant difference between studied groups regarding physical and emotional parameter of a child’s opinion of PEDSQL score as they were higher in HCV treated cases (group II) (Mean = 15.0 ± 3.38) & (Mean = 14.6 ± 4.73) respectively (Table 3). There was a statistical significant difference between studied groups regarding social and school functioning param-eters of parents’ report of PEDSQL score as they were higher in HCV treated cases (group II) (Mean = 13.13 ± 2.8) & (Mean = 11.27 ± 2.08) respectively (Table 4). There was a statistical significant difference between studied groups regard-ing school functionregard-ing parameter of a child’s opinion of PEDSQL score as it was higher in HCV treated cases (group II) (Mean = 11.3 ± 2.6). There was also a statistical signifi-cant difference between groups I & III, group II & III regard-ing social parameter of a child’s opinion of PEDSQL score as it was higher in HCV treated cases (group II) (Mean = 10.47 ± 2.85), however there was no statistical significant difference between group I & group II regarding social parameter of a child’s opinion of PEDSQL score (Table 5). There was a

statis-tical significant difference between studied groups regarding Depression score as it was higher in HCV treated cases (group II) (Mean = 17.57 ± 5.12) (Table 6).

Discussion

Hepatitis C virus (HCV) infection is one of the major causes of liver disease in Egypt. Overall prevalence of antibody to HCV in the general population is around 15–20%.4In the present study there was no statistical significant difference between studied groups regarding sex and age. There was male predom-inance in both groups 1 and II this is in agreement with The Egyptian Demographic and Health Survey (EDHS) which evi-denced that males had a modestly higher infection rate com-pared to females in areas along the Nile River and evidence where public shaving of beards and cutting of hair has been identified as a route of acquiring HCV infection and education programs may help to reduce transmission in future,14 these results are also in agreement with those of El Naghi et al., who studied the safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in Egyptian children with chronic hepatitis C in Forty-six chil-dren. They were 33 boys and 13 girls, aged between 4 and 19 years (mean 10.32 ± 3.46 years).15 In the current study there was a statistical significant difference between studied groups regarding physical, emotional and school functioning parameters in both parents’ and child’s opinions of PEDSQL

Table 1 Description and comparison between studied groups regarding personal data (sex, age).

Variable Group I (30) Group II (30) Group III (60) P1 (GI&GII) P2 (GI&GIII) P3 (GII&GIII)

Age Mean ± SD 13.03 ± 2.53 13.33 ± 2.4 12.62 ± 2.5 0.639 0.46 0.198

Range (8–17) (8–17) (8–17)

Sex N &% Male 18(60%) 15(50.0) 23(38.3) 0.114 0.052 0.29

Female 12(40%) 15(50.0) 37(61.7)

Table 2 Description and comparison between studied groups regarding physical and emotional parameters of parents’ report of PEDSQL score.

Parent Group I (30) Group II (30) Group III (60) P1 (GI&GII) P2 (GI&GIII) P3 (GII&GIII) Physical Mean ± SD 12.93 ± 4.95 18.03 ± 4.62 9.77 ± 3.1 0.001** 0.001** 0.001**

Range (3–23) (4–23) (2–16)

Emotional Mean ± SD 11.67 ± 3.69 14.67 ± 2.51 5.75 ± 2.73 0.001** 0.001** 0.001**

Range (0–17) (4–17) (0–11)

**highly significant.

Table 3 Description and comparison between studied groups regarding physical and emotional parameter of a child’s opinion of PEDSQL score.

Child Group I (30) Group II (30) Group III (60) P1 (GI&GII) P2 (GI&GIII) P3 (GII&GIII) Physical Mean ± SD 11.53 ± 5.88 15.0 ± 3.38 8.47 ± 3.06 0.007** 0.002** 0.001** Range (2–22) (2–19) (3–15) Emotional Mean ± SD 11.43 ± 6.68 14.6 ± 4.73 4.97 ± 2.36 0.038* 0.001** 0.001** Range (1–13) (1–9) (0–11) * significant. **highly significant.

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score as it was significantly higher in HCV treated cases (group II), also there was statistical significant difference between studied groups regarding social parameter of parents’ report of PEDSQL score as it was significantly higher in HCV treated cases (group II). There was also a statistical significant differ-ence between groups I & III and groups II & III regarding social parameter of a child’s opinion of PEDSQL score. Nydegger et al., reported that in a small group of children who acquired HCV in the first year of life had lower QOL compared to non-infected children.16 Iorio et al., examined QOL in children undergoing treatment for chronic HBV and HCV infection, they showed that while tolerability was not a limiting factor in interferon-alpha treatment in children, QOL deteriorated significantly during treatment and did not return to baseline until approximately three months after stop-ping treatment. They noted three- to four-fold increases in irri-tability and all the psychosocial dimensions of the Sickness Impact Profile (e.g. Social Interaction, Emotional Behavior, and Alertness Behavior) during treatment. They suggest that significant QOL morbidity may accompany interferon-alpha treatment in children as it does in adults.17. Rodrigue et al. assessed the quality of life (QOL), behavioral/emotional func-tioning, and cognitive status of children undergoing treatment for hepatitis C virus prior to treatment and at 24 weeks, 48 weeks, 6 months following treatment, and at two annual follow-up visits. After 24 weeks of treatment, mean physical QOL scores declined significantly for both groups from

base-line to 24 weeks of treatment, although scores remained in the average range. There was no significant time or group effects for behavioral/emotional or cognitive functioning. Three children (5%) in the PEG 2a + RV group and no chil-dren in the PEG 2a + PL group had a clinically significant increase in depression symptoms. For those children who received 48 weeks of treatment, there was no significant time or group effects on any of the outcome measures. A majority of children in both the PEG 2a + RV and PEG 2a + PL groups experienced no clinically significant change in physical QOL, behavioral adjustment, depression, or cognitive func-tioning during or after treatment. Therefore, overall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV.18 IFN is a potent inducer of pro-inflammatory cytokines. Cytokines cause a variety of changes in the brain, abnormali-ties in the hypothalamic-pituitary-axis, neurotransmitter sys-tems, or other mechanisms that lead to symptoms similar to major depression (anhedonia, reduced activity, listlessness, hyperalgesia, altered sleep, altered appetite, and poor mem-ory).19Raison et al. determined the impact of chronic exposure to an innate immune cytokine on human sleep architecture. They noted that chronic exposure to an innate immune cyto-kine reduced sleep continuity and depth and induced a sleep pattern consistent with insomnia and hyper arousal. These data suggest that innate immune cytokines may provide a mechanistic link between disorders associated with chronic

Table 4 Description and comparison between studied groups regarding social and school functioning parameters of parents’ report of PEDSQL score.

Parent Group I (30) Group II (30) Group III (60) P1 (GI&GII) P2 (GI&GIII) P3 (GII&GIII)

Social Mean ± SD 10.57 ± 3.8 13.13 ± 2.8 4.57 ± 2.76 0.004** 0.001** 0.001** Range (0–16) (0–15) (0–10) SchoolFunctioning Mean ± SD 9.53 ± 4.25 11.27 ± 2.08 6.5 ± 3.19 0.049* 0.001** 0.001** Range (1–20) (3–13) (2–14) *significant. **highly significant.

Table 5 Description and comparison between studied groups regarding social and school functioning parameter of a child’s opinion of PEDSQL score.

Child Group I (30) Group II (30) Group III (60) P1 (GI&GII) P2 (GI&GIII) P3 (GII&GIII)

Social Mean ± SD 9.1 ± 6.21 10.47 ± 2.85 4.4 ± 2.38 0.278 0.001** 0.001**

Range (0–20) (0–12) (0–10)

SchoolFunctioning Mean ± SD 8.4 ± 3.89 11. 3 ± 2.6 5.98 ± 2.63 0.001** 0.001** 0.001**

Range (1–16) (1–13) (2–12)

**highly significant.

Table 6 Description and comparison between studied groups regarding Depression score.

Child Group I (30) Group II (30) Group III (60) P1 (GI&GII) P2 (GI&GIII) P3 (GII&GIII) Depression Mean ± SD 13.87 ± 6.54 17.57 ± 5.12 7.65 ± 5.2 0.018* 0.001** 0.001**

Range (1–28) (2–26) (0–20)

*significant. **highly significant.

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inflammation, including medical and/or psychiatric illnesses and insomnia, which, in turn, is associated with fatigue, motor slowing, and altered cortisol.20In the current study there was a statistical significant difference between studied groups regard-ing Depression score which was elevated in HCV treated cases (group II). This is in agreement with Hilsabeck et al.21 and Fontana et al.22who stated that Depression was one of the most common diagnoses in HCV patients. Also these results agree with those of Poynard et al.23and Nozaki et al.24who stated that the variance in rates of IFN-associated depression may be due to a multitude of factors including dosage, screen-ing instruments, co-morbid disease, and predisposition to depressive episodes. They stated that reported rates actually underestimate the prevalence of depression if subjects are only followed for a short period of time. In addition, it appears that the development of depression in IFN-treated individuals may be dependent on both duration of treatment and dosage of IFN, but not on previous personal or family history of depres-sive disorders. In contrast Forton et al.25, Fontana et al.22and Lisa et al.26found that the prevalence of depressed mood or depression scores were not different between treated and untreated patients. Wrona,27found that the presence of antin-uclear antibodies was associated with more severe degree of depression, these results support the hypothesis that HCV dri-ven cellular immune response, rather than HCV itself, plays an important role in pathogenesis of depression. In a review by Menkes and MacDonald, it is suggested that depression during interferon therapy may be associated with increased catabo-lism of tryptophan, the precursor of serotonin (5-HT) and anti-serotonergic effects of interferon have been proposed as a mechanism in the development of interferon-related depres-sion and may explain why patient’s symptoms from interferon therapy can be profoundly improved with Selective serotonin re-uptake inhibitors (SSRI) type antidepressant.28

Conclusion

Overall HRQOL in children with chronic hepatitis C infection with and without treatment using the Peds QLTM 4.0 ques-tionnaire showed decreased physical/emotional functioning, social and school performance however it was lower in chil-dren receiving treatment. Assessment of depression by Chil-dren’s Depression Inventory (CDITM) showed an increase in

depression score in children with and without treatment how-ever it was higher in children receiving treatment.

Conflict of interest

The authors declare no conflicts of interest. References

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