Effective Treatment of Chronic Hepatitis C Virus Infection With Ledipasvir/Sofosbuvir in 2 Teenagers With HIV Coinfection: A Brief Report

Pokorska‐Śpiewak, Maria; Dobrzeniecka, Anna; Ołdakowska, Agnieszka; Marczyńska, Magdalena

doi:10.1097/inf.0000000000003264

Cited by 6 publications

(6 citation statements)

References 12 publications

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“…This observation was similar to our results: our per-protocol SVR12 rates were 100% irrespective of the HCV genotype, duration of the treatment, previous treatment experience, or baseline extent of liver fibrosis (Table 2). It is worth emphasizing that the treatment was effective in cirrhotic patients and in two participants coinfected with HIV, as described in detail in another paper [25]. In addition, one of our patients had evidence of past HBV infection with detectable anti-HBc total antibodies.…”

Section: Discussionsupporting

confidence: 52%

Real-Life Experience with Ledipasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Virus Infection with Genotypes 1 and 4 in Children Aged 12 to 17 Years—Results of the POLAC Project

Pokorska‐Śpiewak

Dobrzeniecka²,

Aniszewska

et al. 2021

JCM

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Background: Available real-world data on the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) in pediatric patients are limited. In this prospective, open-label, single-center study, we aimed to present our real-life experience with a fixed dose of LDV/SOF (90/400 mg) for the treatment of chronic hepatitis C (CHC) genotypes 1 and 4 in children aged 12 to 17 years. Methods: We analyzed intention-to-treat (ITT) and per-protocol (PP) rates of sustained virological response (SVR), defined as undetectable HCV viral load at posttreatment week 12, in 37 participants treated with LDV/SOF according to the HCV genotype, baseline liver fibrosis, duration of treatment, and experience of the previous ineffective antiviral treatment. There were 32 patients infected with genotype 1 and 5 with genotype 4. Fourteen (38%) participants were treatment-experienced, two were coinfected with HIV, and three were cirrhotic. Two patients qualified for 24 weeks of therapy, and the remaining 35 received 12 weeks of LDV/SOF treatment. Results: The overall ITT SVR12 rate was 36/37 (97%). One patient was lost to follow-up after week 4 of therapy when his HCV RNA was undetectable. All 36 patients who completed the full protocol achieved SVR (36/36, 100%). PP analyses of SVR12 rates according to the HCV genotype, baseline liver fibrosis, duration of the treatment, and previous ineffective treatment were all 100%. A significant decrease in aminotransferase serum levels was observed in the subsequent weeks of the treatment and at SVR assessment compared to baseline. No serious adverse events were reported. Conclusions: The results of this study confirm previous observations of a suitable efficacy and safety profile of LDV/SOF for the treatment of CHC genotypes 1 and 4 in adolescents.

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Section: Discussionsupporting

confidence: 52%

Real-Life Experience with Ledipasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Virus Infection with Genotypes 1 and 4 in Children Aged 12 to 17 Years—Results of the POLAC Project

Pokorska‐Śpiewak

Dobrzeniecka²,

Aniszewska

et al. 2021

JCM

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“…Although DAAs have been approved for treatment of adolescents since 2017, DAA use for treatment of HIV/HCV coinfected children and adolescents in real-world settings has only been reported for 2 adolescents from Poland. 11 In this study, we report outcomes of 6 adolescents living with HIV and chronic HCV in the Ukraine Paediatric HIV Cohort Study who have received DAAs to date. Similar to the results from Poland, 11 our analysis showed that DAA-based treatment was well tolerated and all patients achieved SVR12 within routine clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…11 In this study, we report outcomes of 6 adolescents living with HIV and chronic HCV in the Ukraine Paediatric HIV Cohort Study who have received DAAs to date. Similar to the results from Poland, 11 our analysis showed that DAA-based treatment was well tolerated and all patients achieved SVR12 within routine clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis C Virus Treatment Response to Direct-acting Antivirals Among Adolescents With HIV/HCV Coinfection: Real-world Data From Ukraine

Malik¹,

Malyuta²,

Volokha³

et al. 2022

Pediatric Infectious Disease Journal

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Direct-acting antivirals (DAAs) have been approved for treating chronic hepatitis C virus (HCV) in children and adolescents. Although DAAs have been used in real-world settings for the treatment of HCV monoinfected adolescents, few reports of real-world use of DAAs in children and adolescents who are coinfected with human immunodeficiency virus (HIV) are available. We evaluated the real-world safety and effectiveness of DAAs in HIV/HCV coinfected adolescents from the Ukraine Paediatric HIV Cohort Study including all those for whom treatment outcomes were available by April 2021. Overall, 6 coinfected adolescents had received DAA treatment; 4 with sofosbuvir/ledipasvir (SOF/LDV), 1 with SOF/ LDV+ribavirin, and 1 with SOF/daclatasvir. No patient discontinued treatment due to adverse events and no serious adverse events were reported. All 6 patients achieved sustained virologic response by 12 weeks after the end of therapy. DAA treatment was well tolerated and effective in adolescents with HIV/HCV coinfection in a real-world setting.

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“…Among HIV/HCV-coinfected adults, HCV treatment is highly efficacious with curative rates comparable to those with HCV monoinfection [50,51]. Thus far, at least 11 cases of successful DAA treatment have been reported in coinfected children [15 ▪▪ ,16,52 ▪ ,53].…”

Section: Direct-acting Antiviral Regimens In Real-world Settings and ...mentioning

confidence: 99%

Defer no more: advances in the treatment and prevention of chronic hepatitis C virus infection in children

Honegger

Gowda

2022

Current Opinion in Infectious Diseases

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Purpose of reviewDirect-acting antiviral (DAA) regimens targeting hepatitis C virus (HCV) are now approved for young children. This review examines recent DAA experience in children, current treatment recommendations and challenges, and potential treatment-as-prevention strategies.Recent findingsIn 2021, the US FDA extended approval of two pan-genotypic DAA regimens, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir, to children as young as age 3 years based on high success rates and reassuring safety profiles in registry trials. Similar performance has been replicated with real-world DAA use in thousands of adolescents and in limited reports of children with high-risk conditions, including cirrhosis, cancer, thalassemia and HIV-coinfection. Treatment without delay is now recommended in the USA for viremic children aged 3 years and up to prevent disease progression and future spread. To date, treatment expansion is limited by high rates of undiagnosed paediatric infection. Universal prenatal screening will aid identification of perinatally exposed newborns, but new strategies are needed to boost testing of exposed infants and at-risk adolescents. Postpartum treatment programmes can prevent subsequent vertical transmission but are hampered by low rates of linkage to care and treatment completion. These challenges may be avoided by DAA use in pregnancy, and this warrants continued study.SummaryPaediatric HCV is now readily curable. Substantial clinical and public health effort is required to ensure widespread uptake of this therapeutic breakthrough.

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Effective Treatment of Chronic Hepatitis C Virus Infection With Ledipasvir/Sofosbuvir in 2 Teenagers With HIV Coinfection: A Brief Report

Cited by 6 publications

References 12 publications

Real-Life Experience with Ledipasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Virus Infection with Genotypes 1 and 4 in Children Aged 12 to 17 Years—Results of the POLAC Project

Real-Life Experience with Ledipasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Virus Infection with Genotypes 1 and 4 in Children Aged 12 to 17 Years—Results of the POLAC Project

Hepatitis C Virus Treatment Response to Direct-acting Antivirals Among Adolescents With HIV/HCV Coinfection: Real-world Data From Ukraine

Defer no more: advances in the treatment and prevention of chronic hepatitis C virus infection in children

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