Evaluating Adolescent Hepatitis C Novel Oral Therapies

Treating adolescents with hepatitis C virus (HCV) infection with novel oral regimes is likely to be cost-effective, according to a paper published in The Pediatric Infectious Disease Journal.

Investigators from China used a model to measure the economic and health outcomes of various HCV treatments in order to compare the outcomes to treatment with pegylated interferon α with ribavirin (PR) therapy. They wrote that these novel oral regimes have been approved for treating HCV in adolescents because of their “superior effectiveness and safety,” but the economic impact is still unclear in terms of treating children.

The 4 regimes they tested were ledipasvir/sofosbuvir (LS) for genotypes 1 and 4, sofosbuvir/ribavirin (SR) for genotype 2, and ledipasvir/sofosbuvir/ribavirin (LSR) for genotype 3 HCV infection all to compare with PR therapy.

The investigators collected data from public sources about clinical costs and utility inputs and they also measured quality-adjusted life years (QALYs), costs, and incremental cost-effective ratios (ICERs).

Compared to the PR strategy, the ICERs of LS therapies were $14,699/QALY for genotype 1 and $14,946 for genotype 4 for HCV infection. Investigators determined the ICER for SR strategy for genotype 2 was $42,472/QALY and the ICER of LSR for genotype 3 was $49,409/QALY, compared to the PR strategy.

“Novel oral regimes for adolescents with HCV infection are likely to be cost-effective in the context of the United States and China,” they concluded.

In March, the FDA approved the combination therapy of sofosbuvir and velpatasvir (Epclusa) for the treatment of HCV in children. These drugs had already been approved to treat adults, but now those over 37 pounds, or older than 6 years can be treated with sofosbuvir and velpatasvir as a supplemental combination therapy. The therapy covers HCV strains 1-4 and 6.

The approval came after a study conducted with 173 children with and without cirrhosis showed that there were no differences in pediatric patients compared to adults. Safety and efficacy were also similar to rates in adult patients, those study authors observed.

After 12 weeks of treatment conclusion, the investigators noted 93% of HCV genotype 1, 91% with genotype 3, and 100% with genotypes 2 and 4 had no virus detected, investigators noted.

Contagion® reported in February that patients who receive sofosbuvir therapies for HCV may not need standard care as part of their treatment. A study compared a group of adult patients who received standard monitoring to a group that received minimal monitoring — including blood tests and clinic visits at treatment weeks 4 and 12 and after 12 weeks of treatment completion.

Staff time and patient satisfaction were similar in both groups, the investigators found, and there was also no significant difference in sustained viral response after 12 weeks of treatment between the groups.

“These results don’t apply to complex patients including those with current substance use disorders, active mental illness or decompensated cirrhosis—these patients likely need closer monitoring,” study author Josh Davis, PhD told Contagion earlier this year.