2020-03-22| Trials & Approvals

Gilead’s Antiviral Drug, Epclusa gets FDA Nod for Pediatric Hepatitis C

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Gilead is in the news again, but this time not for its potential COVID-19 treatment. The company announced positive news for tens of thousands of children infected with the Hepatitis C virus when the USFDA approved its antiviral combination regime Epclusa for chronic Hepatitis C in pediatric patients six years and above or who weigh at least 17 kilograms. The approval is based on a Phase 2 clinical trial that evaluated the efficacy and safety profile of the drug. Epclusa regimen combines sofosbuvir, a nucleotide analog inhibitor with velpatasvir, a glycoprotein inhibitor in different concentrations and is already in the market since 2016 as a treatment for HCV infection in adults. Following this approval, Epclusa has become the first pan-genotypic, protease inhibitor-free drug to be approved in the US for both adults and children.

HCV occurs in about 0.15% of 6-11-year-olds and 0.4% of 12-19 year-olds, amounting to 23,000 to 46,000 children in the US alone. Most of the children acquire HCV from their mother if she is carrying the virus but some of them also get it through high-risk practices such as intravenous drug use, which is increasingly becoming the common route of HCV transmission in adolescents and young adults.

“While the treatment of HCV has been transformed in recent years, physicians caring for some children have still needed to take several factors into consideration, including genotype and liver disease severity, when selecting the appropriate treatment plan,” said Kathleen B Schwarz, M.D., Professor of Pediatrics, Johns Hopkins University School of Medicine. “The expanded approval of Epclusa can help eligible children living with HCV combat this life-threatening and debilitating disease.”


Phase 2 Trial Data

Based on its genome, HCV is categorized into 6 major genotypes. Genotype 1 is the most common in the US, found in nearly 75% of all the HCV infections in the country. The drug was, however, tested against all the six genotypes for its efficacy. In the open-label trial, a total of 175 children were enrolled for 12 weeks. The drug worked exceptionally well in children between the age of 12 and 18 with a cure rate of 93% in genotype 1 infection and 100% in the rest of the genotypes. The drug’s performance in children between the ages of 6 to 12 was not as exceptional though. The cure rate for the most common genotype was 93%, 91% for genotype 3 and 100% for the rest of genotypes. However, the safety profile for the drug in the two age groups matched with that of adults with the most common side effects of headache and fatigue.


Epclusa’s Market Share

Epclusa, Gilead’s blockbuster drug, brought in a fair share of money last year. In 2019, it earned $971 million in the US, $553 million in Europe, and $441 million in the other parts of the world. Last year, the company launched the generic version of the drug through its subsidiary Asegua Therapeutics, which snared 19.5% of the total US hepatitis C market and simultaneously snatched a share of the market from its key competitor Abbvie. Gilead smartly priced the generic drug to $24,000 slightly lower than its Abbvie’s Mavyret which was at $26,400. Despite the huge success, Gilead’s HVC franchise has witnessed a significant slowdown across the US and Europe. The company indicates that the slowdown is due to lower average net selling price as well as a reduction in the overall sale owing to the success of the drug in treating HCV.

“Gilead’s continued commitment to HCV elimination includes bringing our medicines to the most difficult-to-cure populations and today’s decision by the FDA represents an important step toward that goal,” said Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences. “With consistently high cure rates in clinical trials and in the real world, Epclusa has the potential to help many of the children living with HCV in the United States.”

Related Article: Eli Lilly Gets FDA Breakthrough Status for Alopecia Drug



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