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Generic version of Harvoni safe, effective HCV treatment for teens
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Research published in the Journal of the Pediatric Infectious Diseases Society suggests that a generic version of ledipasvir-sofosbuvir — marketed in the United States as Harvoni — is safe and effective for the treatment of teens with hepatitis C virus infection.
Study author Hanan M. Fouad, MD, a professor of medical biochemistry at Cairo University, and colleagues wrote that in 2017, ledipasvir-sofosbuvir became the first direct-acting antiviral approved for use in children aged younger than 18 years with genotype 4.
Despite the drug’s efficacy, the cost of treatment has been seen as a barrier to the use of the brand-name medication among adults, the researchers wrote.
“The use of generic forms earlier in adult treatment programs has increased treatment coverage and changed the disease burden,” Fouad and colleagues noted. “Only scanty data are available for the use of generic ledipasvir-sofosbuvir in children.”
The researchers enrolled 46 participants, aged 12 to 18 years or weighing at least 35 kg, who presented to the National Hepatology and Tropical Medicine Research Institute in Cairo. The participants received a daily tablet of ledipasvir-sofosbuvir for 12 weeks. Follow-up continued for 12 weeks after the course was completed. The results were compared with those of 51 HCV-infected adolescents with HCV genotype 4a who were treated with the brand-name drug at the same center earlier.
No participants discontinued the medication because of side effects, which were generally mild. The more frequently reported adverse events included abdominal pain (65.2% generic vs. 72.5% brand name), headache (63% generic vs. 64.7% brand name) and fatigue (60.9% generic vs. 45.1% brand name). Infrequently reported adverse events included backache, blurring of vision, epistaxis, heartburn and recurrent herpes simplex. By the end of the study period, the researchers also observed a significant increase in participants’ weight and height (both P = .001).
According to the researchers, 97.8% of patients achieved SVR12, with one patient lost to follow-up.
Based on these findings, Fouad and colleagues suggested that the generic medication “represents an affordable and effective alternative.” – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.
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