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|China National Medical Products Administration (NMPA) Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for Chronic Hepatitis B Virus (HBV) Infection|
- First New Oral Treatment Approved for HBV in Ten Years Offers Improved Renal and Bone Laboratory Safety Parameters Compared to Tenofovir Disoproxil Fumarate (TDF) –
Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300 mg but at one-tenth of the dose. 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. In clinical trials, Vemlidy demonstrated improved renal and bone laboratory safety parameters compared to Viread.
“With the approval of Vemlidy, physicians can now offer their patients a
treatment that retains the efficacy of TDF while improving renal and
bone safety parameters in clinical trials,” said Prof.
HBV is highly prevalent in
“Chronic hepatitis B remains an urgent public health issue in
Vemlidy’s approval is supported by data from two international Phase 3
studies (Studies 108 and 110) among 1,632 treatment-naive and
treatment-experienced adult patients with HBeAg-negative and
HBeAg-positive HBV disease (including 334 treated in
The most commonly reported adverse events through 96 weeks 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.
The U.S. Prescribing Information for Vemlidy has a Boxed Warning for the risk of post-treatment severe acute exacerbation of hepatitis B. See below for U.S. Important Safety Information and Indication. In the U.S., Vemlidy is only indicated for adult patients with compensated liver disease.
Vemlidy received marketing approval from the
U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions
Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.
Dosage and Administration
VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing Vemlidy. These
risks, uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended
VEMLIDY and VIREAD are registered trademarks of
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Sung Lee, Investors
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