Ledipasvir/Sofosbuvir for 12 weeks is safe and effective in adolescents with chronic hepatitis C virus infection and hematological malignancies undergoing chemotherapy

El-Sayed, M.H.; Ebeid, Fatma Soliman Elsayed; Zekri, Abdel‐Rahman N.; Massetto, Benedetta; Kersey, Kathryn; Osinusi, A.; Zhang, F.; Brainard, D.; El‐Sayed, Wael A.; Elhaddad, Alaa

doi:10.1016/s0168-8278(18)31278-9

Cited by 6 publications

(11 citation statements)

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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%

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%

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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“…Although the level of evidence is low, DAA treatment seems to be safe and well-tolerated in patients with cancer, even when DAA treatment is administered simultaneously with cancer treatment. 5,12,30 A crosssectional study at MD Anderson that evaluated the safety of DAAs given concomitantly with chemotherapy to patients with any type of cancer revealed good overall safety. 31 Adverse events were reported in 16 of 21 patients (76%), but most of these adverse events (15/21; 71%) were grade 1 or 2.…”

Section: Adverse Eventsmentioning

confidence: 99%

“…5 Similarly, smaller studies in patients with lymphoproliferative malignancies showed SVR at 12 weeks rates of 98%-100% with DAAs. 12,14,30 In our experience, administering 8 weeks of DAA treatment with sofosbuvir/ledipasvir or glecaprevir/pibrentasvir in HCV-infected patients with cancer is feasible and effective 40 ; this strategy is recommended for selected patients without cancer, including those without cirrhosis. 21 Short duration therapy offers several benefits.…”

Section: Paucity Of Data On the Efficacy Of Daa Treatment And Optimal Treatment Duration In Patients With Cancermentioning

confidence: 99%

Hepatitis C Virus Infection in Patients With Cancer: Impact on Clinical Trial Enrollment, Selection of Therapy, and Prognosis

2019

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“…It is important to note that, even with a poorer result when compared to others, the SVR rates are still excellent and the benefit of treating people with neoplasms is positively reported in literature, with a rate of 92% viewed as very satisfactory. [24,25,34] .…”

Section: Discussionmentioning

confidence: 99%

A Real-life Study of the Positive Response to DAA-based Therapies for Hepatitis C in Brazil

Vivaldini

Ribeiro

Júnior

et al. 2020

Preprint

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Treating hepatitis C virus (HCV) infections reduces overall mortality and the risk of multiple extrahepatic complications. Direct-acting antivirals (DAAs) are molecules that target specific non-structural proteins of the virus, resulting in the disruption of viral replication and infection. This report describes the activities undertaken to assess the cure of HCV in patients of different age groups, supported by the Viral Hepatitis National Program of the Unified Health System in Brazil. Around 11,000 patients wereevaluated in an electronic retrospective cohort, which used therapeutic schemes with Sofosbuvir (SOF), Daclatasvir (DCV), Simeprevir (SMV), and an association of Ombitasvir, Veruprevir/Ritonavir and Dasabuvir (3D) with or without Ribavirin (RBV), with sustained virologic response (SVR) or viral cure after a 12-week treatment. We conducted logistic regressions to identify factors independently associated with positive response to DAA-based therapies. Among evaluated patients, 57.1% were male; 48.3% identified as white; 78.3% were over 50 years old; 44.1% were from the Southeast region; 47.7% had genotype 1b; and 84.5% were treated for 12 weeks. The SVR rates with DAAs ranged from 87% to 100%. Genotypes 1 and 4 had a better response (96.3 to 100% of SVR) to therapy with DAAs, and genotypes 2 and 3 had SVR of 90.6% to 92.2%. Different treatment periods showed SVR with an average of 95.0% and 95.9% for 12 and 24 weeks, respectively. In the odds ratio assessment, we verified that females were half as likely (OR 0.5; CI 95% 0.4-0.6) to have a negative response to therapy, when compared to males, and that genotypes 2 and 3 were around twice more likely (OR 1.5-2.2; CI 95% 0.7-2.9; 1.2-3.6 and OR 2.7-2.8; CI 95% 2.0-3.8, respectively) to not have SVR after therapy when compared to genotype 1. Patients aged between 50 and 69 years old were 1.2 times (OR 1,2; CI95% 0,7-1,9) more likely to not have SVR when treated with DAAs, when compared to other age groups. This study is the first of this magnitude to be held in a Latin-American country with high SVR results, supported by a free-of- charge universal and public health system. We confirm the high performance of DAA-based therapies which support the Brazilian public health policy decision of adopting them as an important part of the countrys strategy to eliminate HCV by 2030.

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Ledipasvir/Sofosbuvir for 12 weeks is safe and effective in adolescents with chronic hepatitis C virus infection and hematological malignancies undergoing chemotherapy

Cited by 6 publications

References 0 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

Hepatitis C Virus Infection in Patients With Cancer: Impact on Clinical Trial Enrollment, Selection of Therapy, and Prognosis

A Real-life Study of the Positive Response to DAA-based Therapies for Hepatitis C in Brazil

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