High Rates of Svr12 in Adolescents Treated with the Combination of Ledipasvir/Sofosbuvir

Schwarz, K. B.; Murray, Karen F.; Rosenthal, P; Bansal, Sanjay; Lin, Chung-Chi; Ni, Liyun; Kanwar, Bittoo; Fraser, John G.; German, Polina; Brainard, Diana M.; Wen, Jessica; González‐Peralta, Regino P.; Jonas, M.; Balistreri, William F.

doi:10.1016/s0168-8278(16)01697-4

Cited by 5 publications

(5 citation statements)

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“…Similar excellent results were recently reported in abstract form for the combination of sofosbuvir-ribavirin in adolescents with HCV genotype 2 and 3 infection with SVR of 100% and 97%, respectively (27).…”

Section: Present Standard Treatment Of Hcv Infection In Childrensupporting

confidence: 87%

“…In the first “all oral” pediatric trial reported, the use of fixed‐dose combination sofosbuvir/ledipasvir in children 12‐ to 17 years’ old infected with HCV genotype 1 demonstrated satisfactory pharmacokinetic and tolerability profiles and high rates of SVR12 (98%) (26). Similar excellent results were recently reported in abstract form for the combination of sofosbuvir‐ribavirin in adolescents with HCV genotype 2 and 3 infection with SVR of 100% and 97%, respectively (27). Basing on these results, the FDA recently approved the use of sofosbuvir and ribavirin and the fixed‐dose combination sofosbuvir/ledipasvir for children 12 years of age and older (or weighing at least 35 kg) with HCV genotype 2 or 3 and 1, 4, 5, or 6 infection, respectively.…”

Section: Prevalence Of Hepatitis C Virussupporting

confidence: 86%

“…Have children been left behind in the HCV treatment revolution? As noted, partial results of only two DAA pediatric trials have been reported to date 26,27) The cure of HCV infection is possible for almost all individuals treated with interferonfree, oral DAA combination regimens. Global elimination of hepatitis C virus is presently hampered by the above noted barriers, especially poor screening and identification of infected people, and the high price tag of expensive, but very efficacious and safe DAA drugs.…”

Section: Treatment Of Children With Daas: Is Delay Of Therapy Justified?mentioning

confidence: 99%

“…Have children been left behind in the HCV treatment revolution? As noted, partial results of only 2 DAA pediatric trials have been reported to date (26,27), whereas others are ongoing. In addition, several developmental plans to support authorization of combination DAA regimens for children have been submitted by pharmaceutical companies to the European Medicines Agency (EMA) and FDA, but the current timelines for completion of approved plans are in the distant future.…”

Section: Prevalence Of Hepatitis C Virusmentioning

confidence: 99%

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The Challenge of Treating Children With Hepatitis C Virus Infection

Indolfi

Thorne

El-Sayed

et al. 2017

J. pediatr. gastroenterol. nutr.

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The development of oral hepatitis C virus (HCV) direct-acting antivirals (DAAs) has revolutionized the therapeutic field. Nowadays, multiple safe and highly effective antiviral regimens are commercially available to treat adults with hepatitis C infection. These new regimens for the first time genuinely raise the prospects of eradicating HCV. Many challenges, however, remain from identifying infected individuals to optimizing treatment and ensuring global access to antiviral therapy to all population groups, including children. Recently, in April 2017, the association of sofosbuvir with ribavirin and the fixed-dose combination sofosbuvir/ledipasvir have been approved by the Food and Drug Administration for treatment of children with chronic HCV infection 12 years of age and older. The only drugs currently approved for children younger than 12 years are pegylated interferon and ribavirin. There are 6 registered ongoing pediatric trials assessing safety and efficacy of DAAs, but their current completion timelines are years away. Herein, we summarize the state of the art of DAAs' development for adult and children and highlight the crucial importance of overcoming barriers to treating children with HCV.

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Section: Present Standard Treatment Of Hcv Infection In Childrensupporting

confidence: 87%

Section: Prevalence Of Hepatitis C Virussupporting

confidence: 86%

Section: Treatment Of Children With Daas: Is Delay Of Therapy Justified?mentioning

confidence: 99%

Section: Prevalence Of Hepatitis C Virusmentioning

confidence: 99%

See 2 more Smart Citations

The Challenge of Treating Children With Hepatitis C Virus Infection

Indolfi

Thorne

El-Sayed

et al. 2017

J. pediatr. gastroenterol. nutr.

View full text Add to dashboard Cite

show abstract

“…The first study of any DAA therapy in children and adolescents was reported at the 2016 International Liver Congress in Barcelona. One hundred adolescents aged 12-17 years received 12 weeks of standarddosing ledipasvir/sofosbuvir and achieved 97% SVR without any virologic failures (68). Additional studies are ongoing, including an evaluation of paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin in genotype 1 (NCT02486406) and sofosbuvir with ribavirin in genotypes 2 and 3 (NCT02175758).…”

Section: Unmet Medical Needsmentioning

confidence: 99%

Oral Combination Therapies for Hepatitis C Virus Infection: Successes, Challenges, and Unmet Needs

Naggie¹,

Muir²

2017

Annu. Rev. Med.

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The current standard of care for the treatment of hepatitis C virus (HCV) consists of interferon-free direct-acting antiviral (DAA) regimens, including combinations of DAAs and fixed-dose combination pills. DAAs for HCV are likely to be heralded as one of medicine's greatest advancements. Viral eradication rates are pushing 100% for many HCV-infected populations, including patients with HIV/HCV coinfection, decompensated cirrhosis, liver and kidney transplants, and end-stage liver disease. We highlight the greatest successes of combination DAA therapies, discuss the ongoing challenges, and identify the remaining patient subgroups with unmet medical needs.

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