Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major

Nagral, Aabha; Jhaveri, Ajay; Sawant, Smita; Parikh, Nirzar S.; Nagral, Nishtha; Merchant, Rashid; Gandhi, Mihir

doi:10.1007/s12098-018-2752-7

Cited by 22 publications

(27 citation statements)

References 18 publications

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“…In total, 39 references met the inclusion criteria. Twenty‐eight papers were published as full‐text articles 3‐8,11‐32 and 11 as abstracts 33‐43 . Two studies were randomised clinical trials, 27,33 whereas all the other studies were nonrandomised studies.…”

Section: Resultsmentioning

confidence: 99%

“…All studies were at low risk of bias in classification of interventions, measurement of outcome and selection of the reported result (Appendix A2). Regarding bias due to deviations from intended interventions, 13 studies were judged at moderate risk 4‐8,11,14,21,24,30,35,40,42 and one at serious risk 41 . As for bias due to missing data, five studies were considered at moderate risk 5,8,14,24,40 and four at serious risk 30,35,38,41 .…”

Section: Resultsmentioning

confidence: 99%

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Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

Indolfi

Giometto

Serranti

et al. 2020

Aliment Pharmacol Ther

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SummaryBackgroundThe effect of direct‐acting anti‐virals (DAAs) in children and adolescents with chronic hepatitis C virus (HCV) infection is difficult to determine, since few, aged between 3 and 18 years, have been enrolled in clinical trials, and some data come from observational studies.AimTo summarise the evidence on efficacy and safety of DAAs in children and adolescents with chronic HCV infection.MethodsWe performed a systematic review and meta‐analysis of prospective studies on the efficacy and safety of DAAs in subjects <18 years of age. We considered the sustained virological response at post‐treatment week 12 as efficacy outcome and adverse events as safety outcome. We considered intervention effect for each study arm by calculating the proportion of sustained virologic response at post‐treatment week 12 in subjects receiving all doses of treatment and proportion of adverse events in subjects receiving at least one dose of treatment. Pooled proportions were calculated using the Freeman‐Tukey double arcsine transformation. Random effects model was used for all analyses.ResultsAmong 39 included studies (1796 subjects), the pooled proportion among those receiving all doses of treatment and reaching sustained virologic response at post‐treatment week 12 was 100% (95% confidence interval: 100‐100). Considering subjects receiving at least one dose of treatment, lowest estimates were reported among children with cirrhosis (83%). Headache and fatigue were the most common adverse events. Serious adverse events were uncommon.ConclusionsChildren and adolescents with chronic HCV infection can be safely treated with DAAs with similar efficacy as reported in adults.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

Indolfi

Giometto

Serranti

et al. 2020

Aliment Pharmacol Ther

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“…Other minor negative side effects included headache and nausea. Nagral et al explored the efficacy and safety of DAAs in adolescents with thalassemia major. Regimens included SOF/LDV and SOF/DCV with two patients in the latter group also receiving RBV.…”

Section: Summary Of Studies Treating Hcv Using Daas In Patients With mentioning

confidence: 99%

“…Recently, Sharara et al reported 100% SVR with the pangenotypic single‐tablet combination of SOF/velpatasvir (VEL), and no adverse events in seven patients with genotype 4 HCV infection. Table summarizes the literature on various DAA regimens in the thalassemia population …”

Section: Summary Of Studies Treating Hcv Using Daas In Patients With mentioning

confidence: 99%

Treatment of Chronic HCV Infection in Patients With Thalassemia

Daher

Sharara

2019

Clinical Liver Disease

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Thalassemia is an inherited blood disorder characterized by decreased or absent globin-chain production. With nearly 60,000 individuals affected every year, thalassemia is one of the most common genetic diseases in the world. 1 The lifelong need for blood transfusions in thalassemia makes these patients vulnerable to transfusion-transmitted viral infections, notably hepatitis C virus (HCV). Infection with HCV results in chronic infection in a vast proportion of individuals, and the prevalence rate of chronic hepatitis C in patients with thalassemia major in the EMRO (WHO Regional Office for the Eastern Mediterranean) region ranges from 11% to 69% depending on the age of the patient and the local seroprevalence of HCV ( Fig. 1). 2,3 Although the natural history of chronic HCV infection in patients with thalassemia is unclear, the morbidity and mortality of those patients is thought to be increased. Liver disease is more severe in patients with thalassemia and may be accelerated by hepatic siderosis. Hepatic iron overload, in transfusion-dependent thalassemia, negatively affects the outcome of liver disease, leading to more severe hepatic inflammation and fibrosis, and is associated with a diminished response to interferon-based regimens. 2,[4][5][6] Treatment of HCV in patients with thalassemia is aimed at viral eradication, resolution of liver inflammation and control or reversal of fibrosis, reduction of the risk for hepatocellular carcinoma, and improvement of healthrelated quality of life and survival. However, the major impediment to the treatment of HCV infection in patients with transfusion-dependent thalassemia has been the risk for ribavirin (RBV)-associated hemolysis, as well as the effect of iron overload on virological response rates and the potential for drug-drug interactions with various iron chelators. Initial studies using interferon monotherapy had shown a sustained viral response rate of ~30%, 7-9 whereas limited case series confirmed that the addition of RBV with

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“…This combination resulted in an SVR of around 52% in patients infected with HCV GT 1 and 4, and 89% in those infected with HCV GT 2 and 3, but was associated with significant side effects ( 54 – 56 , 58 ). Compared to IFN-based regimens, DAAs not only are more efficient but also have fewer side effects ( 10 – 12 , 15 – 17 , 22 , 24 – 26 , 28 , 29 , 31 , 34 – 39 ). We found that the overall SVR12 rate for the adolescents and children treated with DAAs was 99.4 and 98.9%, respectively, although the frequency of AEs was substantial (34.7 and 51.6%).…”

Section: Discussionmentioning

confidence: 99%

High SVR12 With 8-Week Course of Direct-Acting Antivirals in Adolescents and Children With Chronic Hepatitis C: A Comprehensive Analysis

Dong

Zhang

et al. 2021

Front. Med.

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Direct-acting antiviral (DAA) treatment for 8 weeks has a sustained virological response rate in adults with chronic hepatitis C. We have conducted a systematic review and meta-analysis to compare the efficacy and safety of the 8-week vs. 12/24-week DAA treatment in adolescents and children with CHC. The PubMed, Web of Science, and Cochrane databases were searched for the relevant articles from January 1, 2017 to August 28, 2020 and further screened for literature reviews on April 1, 2021. Pool proportions with 95% CIs for SVR12 were summarized with fixed/random effects models using Freeman–Tukey double arcsine transformation. Subgroup analysis was used to explore the source of heterogeneity. Thirty-six relevant publications were identified. For adolescents aged 12–17 years old, the pooled SVR12 and AE rate were 99.4% (95% CI: 98.7–99.9) and 34.7% (95% CI: 31.9–37.6). No one discontinued treatment due to drug intolerance. In addition, the SVR12 adolescents treated for 12 and 8/24 weeks were 99.3% (95% CI: 98.4–99.9) and 100%, respectively. The pooled SVR12 rate, AEs, and SAEs for children younger than 12 years were 98.9% (95% CI: 97.3–99.8), 51.6% (95% CI: 47.0–56.2), and 1.1% (95% CI: 0.4–2.5), respectively. The most common AE was fatigue (28.4%). The SVR12 was 98.8% (95% CI: 97.1–99.8) and 100% for the pediatric patients treated for 12 weeks and 8/24 weeks, respectively. Taken together, DAAs are generally effective against CHC and well-tolerated by the adolescents and children. A treatment duration of 8 weeks is equally effective and safe as 12/24 weeks in this demographic group.

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Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major

Abstract: Generic DAAs are effective and safe in TM adolescents with HCV.

Cited by 22 publications

References 18 publications

Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

Treatment of Chronic HCV Infection in Patients With Thalassemia

High SVR12 With 8-Week Course of Direct-Acting Antivirals in Adolescents and Children With Chronic Hepatitis C: A Comprehensive Analysis

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