What do doctors think of Harvoni

Ledipasvir / Sofosbuvir (Harvoni) in children with chronic hepatitis C.

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG) examined the advantages and disadvantages of ledipasvir / sofosbuvir for children with chronic C compared to wait-and-see observation.

For this question, IQWiG evaluated three studies that provide at least preliminary answers to some questions. The studies looked at ledipasvir / sofosbuvir treatment but did not compare it directly with any other. The results of such studies are generally not very meaningful.

Children with chronic C can be divided into different groups according to the stage of their illness and previous therapy. Data from the studies were available for the following group:

  • Initial or subsequent therapy in children with chronic C of 1 or 4 without

IQWiG evaluated the data from a total of 157 children. All children took ledipasvir / sofosbuvir once daily for 12 or 24 weeks. The following results were shown:

Secondary illnesses: The studies did not last long enough to assess the influence of ledipasvir / sofosbuvir on secondary diseases. However, initial assessments indicate an advantage of ledipasvir / sofosbuvir:

  • At least 95 out of 100 children were no longer detectable in their blood after 12 weeks after completing treatment.
  • One of the studies also provides data over a period of 24 weeks: after 24 weeks, about 98 out of 100 children were no longer detectable in the blood.

Such favorable results are not known for wait-and-see observation and are not to be expected. How big the advantage of ledipasvir / sofosbuvir actually is cannot be conclusively assessed.

Life expectancy: None of the participants died in the studies.

Serious side effects and discontinuation of therapy due to side effects: Less than 1 in 100 children experienced a serious side effect. Less than 1 in 100 children dropped out because of side effects.