Pegylated interferon-based sequential therapy for treatment of HBeAg reactive pediatric chronic hepatitis B—First study in children

Lal, Bikrant Bihari; Sood, Vikrant; Khanna, Rajeev; Rawat, Dinesh; Verma, Sanjeev Kumar; Alam, Seema

doi:10.1007/s12664-018-0878-1

Cited by 10 publications

(17 citation statements)

References 36 publications

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“…However, the difference in benefits between IFN‐α and Peg‐IFN‐α‐2a antiviral therapy should be further evaluated in RCTs by enlarging the sample size 21 . Additionally, some studies reported that the combination of initial nucleoside/nucleotide analogs (NAs) and IFN‐α, and initial NAs and add‐on Peg‐IFN‐α‐2a therapy were safe and beneficial in children with CHB 11,22 (Table 1). Our recent review and meta‐analysis reported that compared to IFN‐α monotherapy, the initial combination of NAs and IFN‐α, IFN‐α add‐on NAs and IFN‐α switch‐to NAs had similar outcomes in adult CHB patients 23 .…”

Section: Discussionmentioning

confidence: 99%

Long‐term benefits of interferon‐α therapy in children with HBeAg‐positive immune‐active chronic hepatitis B

Wang

Zhao

Liu

et al. 2021

Journal of Viral Hepatitis

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The long‐term benefits of interferon‐α (IFN‐α) treatment in children with chronic hepatitis B (CHB) remain unclear. We conducted a retrospective and real‐world study to evaluate the safety and long‐term clearance rates of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) in CHB children who received IFN‐α monotherapy for 72 weeks and were with 13‐year follow‐up visit. Participants treated with IFN‐α (n = 316) were more likely to become HBeAg negatve (39.87% vs. 27.37%; p < .05) and HBsAg negative (11.08% vs. 3.16%; p < .05) by the end of the treatment period than untreated participants (n = 95). Treated participants also had higher cumulative rates of HBeAg loss (74.13% vs. 59.27%; p < .05) and HBsAg loss (46.95 vs. 33.11%; p < 0.05) than untreated participants in parallel by the end of 13‐year follow‐up. In particular, the cumulative rate of HBsAg loss was higher in treated children aged 1–7 years than in those aged 8–17 years (71.40% vs. 39.0%; p < .01). Children who were HBeAg‐negative at the end of IFN‐α treatment or who had serum alanine aminotransferase levels of ≥80 IU/L at baseline were likely to have higher cumulative HBsAg loss rates. Accordingly, HBeAg loss at 72 weeks was positively associated with the cumulative HBsAg loss rate in untreated children. There were no serious adverse events of IFN‐α therapy for the treated patients throughout the study period. Overall, IFN‐α therapy was effective in obtaining higher long‐term cumulative rates of HBeAg and HBsAg loss in children with HBeAg‐positive immune‐active CHB, especially among those aged 1–7 years.

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Section: Discussionmentioning

confidence: 99%

Long‐term benefits of interferon‐α therapy in children with HBeAg‐positive immune‐active chronic hepatitis B

Wang

Zhao

Liu

et al. 2021

Journal of Viral Hepatitis

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“…There are no pediatric studies to evaluate the timing and criteria for stopping antiviral therapy in children. Very low HBsAg seroconversion (1.7 -8.3%) and HBeAg seroconversion (21 -31.3%) rates observed in children on antivirals implies longer, often inde nite antiviral therapy [7][8][9][10]. Longer duration of therapy increases the cumulative risk of adverse events as well as risk of development of antiviral resistance [15].…”

Section: Discussionmentioning

confidence: 99%

“…There is no ambiguity in stopping antiviral therapy in children who achieve hepatitis B surface antigen (HBsAg) seroclearance. However, only 1.7 to 8.3% of children treated with antivirals achieve HBsAg seroclearance [7][8][9][10]. There is no consensus about the duration of antiviral therapy in the vast majority who continue to remain HBsAg reactive.…”

Section: Introductionmentioning

confidence: 99%

“…There is no consensus about the duration of antiviral therapy in the vast majority who continue to remain HBsAg reactive. Initiation of antivirals at a very young age in children coupled with lack of de nite endpoint for stopping therapy implies extremely long cumulative duration of exposure to antivirals, thereby increasing the risk of adverse events and drug resistance [7][8][9][10]. The incidence and predictors of relapse after stopping antiviral treatment in children with CHB has never been studied previously.…”

Section: Introductionmentioning

confidence: 99%

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Incidence And Predictors of Relapse After Stopping Antiviral Therapy In Pediatric Chronic Hepatitis B

Upadhyay

Lal

Sood

et al. 2021

Preprint

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Objective: The objective was to evaluate the incidence of relapse after stopping antiviral therapy and to identify the predictors of relapse. Methods: All HBsAg positive children with who had been on antivirals for at least 2 years with undetectable HBV-DNA and normal alanine-aminotransferase (ALT) on three consecutive occasions over last 12 months were included. Antivirals were stopped if liver biopsy showed histological activity index <5 and fibrosis (metavir) <3. Children were monitored for virological relapse (elevation of HBV-DNA >2000 IU/mL) and biochemical relapse (ALT levels >2 × upper limit of normal (ULN)). Those having biochemical relapse were started on pegylated interferon alpha-2b based sequential therapy. Results: Antivirals were stopped in 31 HBsAg positive children. Virological and biochemical relapse was seen in 12 (38.7%) and 5 (16.1%) children within 12 months of stopping antiviral treatment. Majority of virological relapse occurred within a month and biochemical relapses within 6 months of stopping therapy. HBeAg positive status at the time of stopping antiviral therapy (HR: 7.206, p =0.005) and longer time taken for HBV-DNA to become undetectable while on antivirals (HR: 1.030, p=0.037) were found to be the 2 independent predictors of relapse after stopping antiviral treatment. Conclusion: Discontinuation of antiviral treatment in children with CHB resulted in relapse in one third of the patients. Relapse was more common in those with HBeAg positivity at the time of stopping therapy and in those with longer time taken for HBV-DNA to become undetectable on antivirals.

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“…Thirdly, regarding the regimen of initial interferon (IFN) followed by the combination of IFN and lamivudine (LAM), the rationale for this sequence is based on the first guideline recommendations for the treatment of children with CHB. [7][8][9] IFN has a longer history in the treatment of children with CHB than nucleoside analogues (NAs) and its safety and efficacy have been demonstrated by many studies. 10 Indeed, in our study, one patient in the treatment group responded well to IFN monotherapy.…”

Section: Reply To: ''Immunotolerant Children With Chronic Hepatitis Bmentioning

confidence: 99%

Immunotolerant children with chronic hepatitis B – To treat or not – The dilemma continues

Lal

Sood

Khanna

et al. 2018

Journal of Hepatology

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Pegylated interferon-based sequential therapy for treatment of HBeAg reactive pediatric chronic hepatitis B—First study in children

Abstract: Sequential therapy leads to higher HBe seroconversion and virological response in children in IA phase. Children with baseline ALT > 100 IU/mL are more likely to respond to sequential therapy. There appears to be no role of sequential therapy in children in IT phase.

Cited by 10 publications

References 36 publications

Long‐term benefits of interferon‐α therapy in children with HBeAg‐positive immune‐active chronic hepatitis B

Long‐term benefits of interferon‐α therapy in children with HBeAg‐positive immune‐active chronic hepatitis B

Incidence And Predictors of Relapse After Stopping Antiviral Therapy In Pediatric Chronic Hepatitis B

Immunotolerant children with chronic hepatitis B – To treat or not – The dilemma continues

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