Hematological Adverse Events and Sustained Viral Response in Children Undergoing Therapy for Chronic Hepatitis C Infection

Abstract

BackgroundTreatment of hepatitis C virus (HCV) infection with interferon (IFN) and ribavirin (RBV) is associated with adverse events, which may affect the patient's adherence to the treatment regimen and the treatment efficacy.ObjectivesThe aim of this study was to assess the sustained viral response (SVR) and interdependence between the haematological characteristics (leukocyte count, platelet count, and haemoglobin levels) in patients with chronic hepatitis C (CHC) infection during treatment with IFN and RBV.Patients and MethodsWe conducted a retrospective cohort study of 170 children with CHC infection who completed treatment with IFN-α and RBV. The children were divided into 2 groups: the first group (group I, n = 119) underwent a 48-week course of treatment with recombinant IFN α-2b (Intron A) at a dosage of 3 MU 3 times a week subcutaneously and RBV at a dosage of 15 mg/kg per day orally, and the second group (group II, n = 51) was administered pegylated IFN (peg-IFN)-α-2b (PegIntron) at a dosage of 1.5 μg/kg per week subcutaneously and RBV at a dosage of 15 mg/kg per day orally for 48 weeks. The dose of IFN was not adjusted but that of ribavirin was in 2 children from group II. Hematological growth factors and erythropoietin were not used. SVR was defined as undetectable serum HCV RNA 24 weeks after the end of treatment (study week 72). Serum HCV RNA was determined by performing polymerase chain reaction, and the HCV genotypes and hematological parameters were evaluated. Serum HCV RNA levels were analysed by descriptive statistics. Means and standard deviations were calculated for values collected at the baseline, on the 12th and 48th weeks during treatment, and after 24 weeks of untreated follow-up (study week 72).ResultsEighty-six (50%) of the 170 patients who underwent treatment achieved SVR: 62 (51%) out of 119 children from group I and 24 (47%) out of 51 from group II. The mean serum hemoglobin levels and leukocyte and platelet counts at week 12 were significantly lower than the baseline values in both responders and non-responders from both the groups (P < 0.05). In the responders in group I, the mean levels of serum hemoglobin after 24 weeks of treatment and at the end of therapy were significantly lower than the mean levels at baseline. In the group treated with peg-IFN-α-2b and RBV (group II), the mean serum hemoglobin levels at week 12 was lower in the responders than in the non-responders (P < 0.05). The decrease in the hemoglobin levels was associated with viral response. In both the responders and non-responders from both the groups, leukocyte counts decreased during treatment, and after 12 weeks, they were more significantly lower than the baseline value. The decrease was more marked in children treated with peg-IFN-α-2b + RBV (P < 0.05). After 12 weeks of treatment, the platelet count was low in children from group II who had achieved SVR.ConclusionsA mild decrease in hemoglobin levels and leukocyte and platelet counts during treatment with IFN and RBV in children with CHC infection may be f...

Optimal management of pediatric hepatitis C infection: a review

“…6,15,18 Clinical symptoms are observed in approximately 20% of the infected children, with hepatomegaly being the most frequently observed sign. 19,20 According to Bortolotti et al, 15.4% of children had nonspecific, mild, and transient symptoms at the time of diagnosis. Nevertheless, 1.8% with constantly high ALT levels developed signs and symptoms of advanced liver disease (asthenia, epistaxis, pruritus, ascites, gastrointestinal bleeding).…”

Sustained Viral Response and Hematological Adverse events During Chronic Hepatitis C Infection Treatment

“…Recently, oral protease inhibitors ( e.g., telaprevir or boceprevir) have been added as direct-acting antivirals to the SOC treatment as a triple therapy, particularly in patients with HCV genotype 1 [ 7 ]. We were interested in Pawlowska et al's study, which examined correlations between the hematological adverse events and the SVR in children undergoing therapy for chronic HCV infection [ 8 ]. Specifically, Pawlowska et al assessed the interdependence of the SVR and the hematological characteristics (leukocyte count, platelet count, and hemoglobin levels) in patients with chronic HCV infection during treatment with IFN and RBV.…”

“…In a similar study by Sievert et al [ 9 ] the virologic responses were also higher in anemic patients than in patients who did not develop anemia. After 12 weeks of therapy, the leukocyte and platelet counts were significantly lower in children treated with pegylated IFN-α-2b plus RBV than in those treated with conventional IFN plus RBV [ 8 ]. The hematological toxicity that occurs during therapy can result in modifications in dosage or even, in the worst-case scenario, withdrawing INF therapy, which decreases the chances of successful therapy and increases the risk of impaired liver function with cirrhosis and HCC as potential consequences [ 10 ].…”

Sustained Viral Response and Hematological Adverse Events in Children With Chronic Hepatitis C

“…Sustained viral response (SVR), was defined as an undetectable level of HCV-RNA 24 weeks after the end of treatment, and this was achieved by 51% and 47% of patients from group 1 and group 2, respectively. In both groups, the hemoglobin levels as well as the leukocyte and platelet counts, both during treatment and following 12 weeks of therapy, were lower in patients reaching SVR [ 3 ]. The rate of SVR reported by the literature in pediatric population for PEG-IFNα plus ribavirin therapy is set between 30 to 100% [ 1 ], which is comparable to the rate observed in adults [ 2 ].…”