FDA Approves Two Hepatitis C Drugs Sovaldi And Harvoni For Children
The U.S. Food and Drug Administration has given the green signal to two new drugs manufactured especially for pediatric patients suffering from the hepatitis C virus.
On Friday, April 7, the FDA granted approval to Gilead Sciences' new drugs — Harvoni and Sovaldi — for treatment of chronic hepatitis C infections in children between 12 years and 17 years. These drugs were previously used to treat hepatitis C virus, or HCV, infections in adults.
How Will The Drugs Help Children
The FDA shared that the newly-approved drugs were the world's first direct-acting antiviral medications, which have received approval for kids and adolescents suffering from HCV.
A direct-acting antiviral drug essentially reduces the quantity of HCV present in the body. It does so by stopping the virus from reproducing. In most cases, application of these drugs goes on to cure HCV completely.
"These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents," said FDA's Edward Cox.
Harvoni And Its Cure
The approved drug will be now able to treat six major infections of HCV present in the body. Harvoni will be used to treat kids 12 years or older diagnosed with HCV infection 1, 4, 5, or 6. To be eligible for receiving the medicine, these kids will have to weigh at least 77 pounds. Moreover, they should not be suffering from cirrhosis or even mild cirrhosis.
The efficiency, safety, and pharmacokinetics of the Harvoni drug for HCV strain 1 infection was proved and confirmed in an open-label, clinical trial that took place in various centers. The trial included 100 children aged 12 years and older, suffering from the above-mentioned strain.
The results that were determined in the pediatric patients were compared to the outcome of the drug observed in adults. It was seen that 98 percent children were cured of the infection after undergoing the trial for 12 weeks.
With regard to the efficacy and safety of Harvoni for HCV genotypes 4, 5, or 6, in children aged 12 years and above, similar results were determined for the drugs. Fatigue and headache were the most common side effects observed in the treatments where Harvoni was administered.
Sovaldi For HCV 2 And 3 Genotype Treatment
For the evaluation of Sovaldi, combined with ribavirin, nearly 50 pediatric patients aged 12 years and above were put under a clinical trial spanning 12 weeks. These patients too had to weigh at least 77 pounds and did not suffer from cirrhosis or mild liver cirrhosis.
At the end of the trial, it was observed that all the patients suffering from HCV strain 2 infection, and 97 percent of kids suffering from HCV 3 genotype, were cured of their respective ailments.
The FDA stated that the patients who will be treated with Sovaldi in combination with ribavirin, may experience headache and fatigue.
Gilead's VP Norbert Bischofberger said that the company's goal was to provide patients suffering from HCV with a treatment, which has the potential to cure them completely.
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