Hepatitis C treatment in adolescents and young people late but successful, Spanish study shows

5 May 2020 Keith Alcorn
Originally published on www.infohep.org

Treatment for hepatitis C was highly effective in clearing the virus in young people coinfected with HIV and hepatitis C through vertical infection, despite advanced fibrosis in one-third, Spanish researchers report in the Journal of Viral Hepatitis.

Children who acquire both HIV and hepatitis C at birth may be at higher risk of liver damage due to hepatitis C than children infected with hepatitis C alone. Direct-acting antiviral treatment for children has lagged behind adult treatment owing to a lack of studies. Sofosbuvir/ledipasvir (Harvoni) was approved for treatment of children and adolescents over the age of 12 years in 2017 in the United States and European Union.

A clinical trial of sofosbuvir/ledipasvir in adolescents aged 6 to 11 years reported in 2017 that the combination was safe and highly effective and Harvoni and sofosbuvir (Sovaldi) were approved for use in children aged 3 years and over by the US Food and Drug Administration in September 2019 for genotypes 1, 2, 4, 5 and 6.

But real-world data on treatment of hepatitis C in adolescents and young people are lacking.

Spanish researchers reported on the outcomes of 80 children and young people vertically infected with HIV and hepatitis C. The children were being followed as part of a national cohort of children and adolescents with HIV and represent around 85% of vertically coinfected children in Spain. Although they form a small proportion of young people living with HIV (around 4%) in the Spanish national cohort, investigators described this group as especially hard to treat, so these findings are relevant for other settings.

A comparison of 67 of the 80 cohort members with children and young people vertically infected with hepatitis C alone showed that by the age of 20, coinfected cohort members were more likely to have developed advanced fibrosis (26% vs 20%). Progression to advanced fibrosis occurred during adolescence in both groups, emphasising the importance of access to direct-acting antiviral treatment before adolescence (Sainz).

Of the 80 children and young people, 27 underwent treatment with direct-acting antivirals between 2015 and 2018. Twenty-two could not be treated due to lack of data on use of the drugs in their age group or concerns about adherence. The remainder were either lost to follow-up or died during follow-up.

The average age of those treated is an indictment of the slow progress in research into hepatitis C treatment in children. The median age at treatment was 23 years and 30% had F3 or F4 fibrosis, indicating advanced liver damage. Only one in four of those treated was under the age of 21. One in five had undergone previous unsuccessful treatment with pegylated interferon and ribavirin, the remainder were previously untreated.

Treated cohort members also had very advanced HIV disease. Just over one in five (22%) had CDC stage C disease – either a CD4 count below 200 or an AIDS-defining illness – at the time they were treated, and treated cohort members had taken a median of seven antiretroviral regimens. All were on antiretroviral treatment at the time of hepatitis C treatment and 24 out of 27 had an undetectable HIV viral load.

The predominant form of direct-acting antiviral treatment was sofosbuvir / ledipasvir (70%) with the remainder treated with one of five combination regimens. Almost all (22 out of 27) underwent 12 weeks of treatment. All were cured of hepatitis C.

“Now that DAAS are approved and available for adolescent use, it would be interesting treating these patients at early adolescence as it is possible and safe,” the study authors conclude. “Treatment of patients before the start of their sexual life would have also benefits in terms of preventing HCV transmission.”