FDA Approves Drugs for Hepatitis C Infected Older Children

The U.S. Food and Drug Administration (FDA) has approved the use of the directly acting agents (DAAs) sofosbuvir (available as Sovaldi) and the combination of ledipasvir and sofosbuvir (available as Harvoni) for the treatment of hepatitis C in children and adolescents between the ages of 12 to 17 years, thereby increasing the possible number of beneficiaries of this new treatment. Hepatitis C can severely affect the liver, resulting in cirrhosis, liver failure or sometimes liver cancer. It spreads through contact with infected blood and blood products, and sexual contact. Children can get affected if the virus passes from the mother to the baby during childbirth.

DAAs have been found to be safe and effective in treating hepatitis C in adults. Drugs like sofosbuvir, simprevir, daclatasvir, and ledipasvir that interrupt important steps in viral replication have been approved for the treatment of hepatitis C in adults.

Currently, there are around 23,000 to 46,000 children in the United States with HCV infection. It is therefore important that the latest and effective treatments are available to children as well. The approval of sofosbuvir and sofusbuvir-ledipasvir combination by the FDA extends the benefits of these drugs to children over the age of 12 years or 35 kg in weight. Some aspects of these treatments in the young population are as below:

• Sofosbuvir can now be used along with ribavirin, another antiviral drug, for the treatment of HCV genotype 2 or 3. The combination of sofosbuvir and ledipasvir (Harvoni) is approved for the treatment of hepatitis C with HCV genotype 1, 4, 5 or 6 infection. Thus, the approvals provide treatments for all major strains of the hepatitis C virus.
• The treatments were evaluated in small clinical trials in young patients and were found to be safe and effective. Harvoni as well as sofosbuvir with ribavirin caused side effects of headache and fatigue
• The sofosbuvir and ribavirin combination should not be administered to those in whom ribavirin is contraindicated
• As in adults, the drugs should be used in only those children who do not have hepatitis B infection, since using these medications can cause flare-ups of the infection
• The medications are permitted to be used only in children with no cirrhosis or with mild cirrhosis

Further experience with these drugs in these populations may extend their effect to younger children as well.

Reference:

1. FDA approves two hepatitis C drugs for pediatric patients - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551407.htm)

Source-Medindia