• linkedin
  • Increase Font
  • Sharebar

    Gilead promises generic versions of new hepatitis drug

    After Gilead Sciences received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of its Sovaldi and Harvoni hepatitis C treatments.

    FDA recently approved tenofovir alafenamide, TAF (Vemlidy) 25 mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. In addition, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

    Related: Cheaper hep C drug enters competitive market

    Meanwhile, Gilead established licensing agreements with 19 generic drug manufacturers in India, South Africa and China, as well as the Medicines Patent Pool, granting them rights to produce and sell high-quality, low-cost generic versions of Gilead HBV medicines in 112 developing countries.

    Plus, since Vemlidy is already an integrated component of the company’s generic licensing agreements, with FDA approval, manufacturing partners “may begin production and distribution of a generic version of this medicine,” Gilead said in a press statement.

    “Chronic hepatitis B is a life-threatening illness that affects up to 2.2 million people in the U.S.,” said Calvin Pan, MD, clinical professor of medicine, NYU Langone Medical Center, and investigator in the Vemlidy clinical trials. “Clinical trials demonstrated Vemlidy is efficacious with improved renal and bone safety parameters compared to Viread, representing an important development for people living with this chronic disease.”

    Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s tenofovir disoproxil fumarate (Viread) 300 mg. “Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread,” Gilead said.

    Related: FDA expands use of hep C drug

    Vemlidy’s approval is supported by 48-week data from 2 international phase 3 studies among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either Vemlidy or Viread, and Study 110 randomized and treated 873 HBeAg-positive patients with either Vemlidy or Viread.

    Both studies met their primary end point of non-inferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.

    In an integrated analysis of both studies, patients receiving Vemlidy demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with Viread. Patients in the Vemlidy arm also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (ALT) levels.

    Vemlidy and Viread were generally well-tolerated by patients in both studies and discontinuations due to adverse events were 1% and 1.2%, respectively. The most commonly reported adverse events in both studies included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or Viread.

    Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs. As a result, Vemlidy carries a boxed warning: Lactic acidosis/severe hepatomegaly with steatosis and post treatment severe acute exacerbation of hepatitis B.

    Read more: Top 7 new facts about drug spending

    The most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, fatigue, cough, nausea and back pain.

    Christine Blank
    Contributing Editor Christine Blank is a freelance writer based in Florida.

    2 Comments

    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • joycesteven101@------.com
      Am here to appreciate MED LAB for curing my hepatitis b virus. since 5 years now I have been living with this virus and it has been giving me challenges, I was so perplexed cause i have been taking several drugs to be cured but all of my effort was in vain,one morning i was browsing through the internet then i saw several testimonies about MED LAB curing people from Herpes virus, Hepatitis b and others, and immediately i contacted MED LAB email: medlab36@gmail.com i told them about my troubles and they told me that i will be cured, gave me some instructions and which i rightly followed. so they sent medicine for me and i used it just 8 days and everything was like a dream to me and my Hepatitis b virus was totally gone, why don't you contact them today and be free from your diseases because life is so sweet and opportunities are await us. contact via email; medlab36@gmail.com
    • xinajulie@------.com
      Good morning to everyone here, Now i see why everyone is always talking about dr.tokubo herbal medicine that it cure all kinds of illness such as Hiv, Herpes, diabetics, asthma, hepatitis, HBP, STD, cancer, chronic, etc. I am a living testimony to this because i have been suffering from Asthma since childhood and i have been on medication by buying in-hearer but there was no permanent cure for the Asthma not until i went on the Internet to search for cure for Asthma which led me to see some comments of those whom dr.tokubo have helped to cure before with his herbal medicine. after reading series of comments about dr.tokubo on a blog i copied out his email and order for his herbs which he directed me on how to to take it and after taking it for a year now i have not been experiencing asthma anymore so i went for hospital for check up i wast tested negative. the reason i am sharing this testimony is to help those who are reading this now to contact dr.tokubo for help because the man is good in herbal medicine and he have herbs that cures Hiv, Herpes, diabetics, asthma, hepatitis, HBP, STD, cancer, chronic, etc. the different between Ordinary and Extra-Ordinary is the "Extra" My dear friends go for the Extra and regain your health back to normal again with doctor tokubo herbs. you can reach him through the below contact informations Contact Dr. tokbuo on DRTOKUBOTEMPLE@GMAIL.COM phone no/whatsap No +2349037990322