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    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.

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    • Anonymous
      My name is Evans from UK, i was diagnosed with Hepatitis B for 2years and i lived in pain with the knowledge that i wasn’t going to ever be well again i contacted so many herbal doctors on this issue and wasted a large sum of money but my condition never got better i was determined to get my life back so one day i saw Mr Peter post on how Dr Ere saved him from the VIRUS with herbal medicine i contacted Dr Ere on his email address [email protected] we spoke on the issue i told him all that i went through and he told me not to worry that everything will be fine again so he prepared the medicine and send it to me through courier service and told me how to use it,after 14days of usage I went to see the doctor for test ,then the result was negative,am the happiest man on earth now ,,contact Dr Ere on his email address [email protected] today and get your cure.
    • Anonymous
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    • Anonymous
      Greetings to the general public, I want to tell about how I was cured of Hepatitis B disease by a Doctor called Dr. Alli. I was browsing the Internet searching for remedy on Hepatitis B and I saw a comment of people talking about how Doctor Alli cured them. I was scared because I never believed in the Internet but i was convince to give him a try because i having no hope of been cured of Hepatitis B so I decided to contact him with his email that was listed on the comment ([email protected]) when I contacted him he gave me hope and send a Herbal medicine to me that I took and it seriously worked for me, am a free person now without problem, my Hepatitis B result came out negative. I pray for you Dr. Alli God will give you everlasting life, you shall not die before your time for being sincere and great men. Am so happy, you can also contact him if you have any problem Email: [email protected] or Add him up on What-sap +2348100772528
    • [email protected]
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    • [email protected]
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    • [email protected]
      hello viwers My name is pamela Gard from usa, i was diagnosed with Hepatitis B for 2years and i lived in pain with the knowledge that i wasn’t going to ever be well again i contacted so many herbal doctors on this issue and wasted a large sum of money but my condition never got better i was determined to get my life back so one day i saw Mrs Isabella post on how Dr paula saved him from the VIRUS with his medicine i contacted Dr paula we spoke on the issue i told him all that i went through and he told me not to worry that everything will be fine again so he prepared the medicine and send it to me through courier service and told me how to use it,after 14days of usage I went to see the doctor for test ,then the result was negative,am the happiest woman on earth now ,,contact Dr paul on his email address [email protected] today and get your cure. you can also reach him on his whats app number+2348128311475. am sure he can also cure any type of disease like HIV/AIDS. this is my number you can also call me and confirm+16623462495../