Gilead has released a new hepatitis B drug, Vemlidy (ingredient: tenofovir alafenamide), which is non-inferior in efficacy to its blockbuster hepatitis drug, Viread, and has fewer side effects than the latter, company officials said Wednesday.
Gilead길리어드 executives and researchers emphasized their new treatment has reduced two major side effects of the old one – kidney toxicity and the reduction of bone mineral density.
“Although Viread is an excellent drug, it sometimes has adverse effects on the patient’s kidney and bone density while Vemlidy does not," said Professor Ahn Sang-hoon안상훈 of Severance Hospital at a news conference. “Because hepatitis B patients have to take medication for five to 10 years, we had to make sure that the drug was safe – Vemlidy has proved to be so.”
Hepatitis B affects 2 million people in the United States alone, and although eradication is not currently an attainable goal, Gilead is leading the way in treatment to make it a reality, said William A. Lee, executive vice president of Gilead’s research division.
Clinical trials confirmed the safety and efficacy of Vemlidy for 48 weeks in 1,298 patients in 22 countries with hepatitis B who had no previous treatment. As a result, Vemlidy demonstrated non-inferiority in comparison to Viread, and the proportion of alanine aminotransferase (ALT) levels was higher than the control group, according to Edward Mena, a hepatologist at Pasadena Liver Center,
Vemlidy베믈리디 is a tenofovir novel targeted product, which reduces tenofovir concentration within the plasma by 89 percent and thereby reduces systemic drug exposure for patients. The findings signify that doctors can now prescribe Vemlidy at a dose of 25 mg compared to Viread’s 300 mg, one-tenth the dose thanks to improved plasma stability.
The new drug is expected to take over the sales of Viread, which is going off patent in November.
When asked about the drug’s competition with Ildong Pharmaceutical’s new hepatitis B drug, Besivo, Lee said, “We can only compare our performance to our previous drug in the clinical trials – in this regard, I can say that it has been superior concerning dosage and safety.”
“Gilead is committed to our HPV patients. We are now introducing our third drug for the disease, and each one has been an improvement because of safety and efficacy; however; we are still not finished – we hope to show you our next best drug in the next few years,” Lee added.