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|December 15, 2017 9:00 a.m.|
|Teva Announces Exclusive Launch of a Generic version of Viread® in the United States|
Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. Additionally, tenofovir disoproxil fumarate tablets are an HBV reverse transcriptase inhibitor, indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
"Currently, 1.1 million people in the U.S are living with HIV2 and an estimated 850,000 to 2.2 million have chronic hepatitis B virus infection,"3 said Brendan O'Grady, Executive Vice President, North America Commercial at Teva.. "The launch of our generic version of Viread® is an important addition to our portfolio; but, more importantly, it brings an effective, affordable treatment option to these patients in an area that's lacking."
With nearly 600 generic medicines available, Teva has the largest
Viread® had annual sales of approximately
About Tenofovir Disoproxil Fumarate Tablets
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease. Tenofovir disoproxil fumarate tablets were evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy.
Important Safety Information
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir disoproxil fumarate. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, alone or in combination with other antiretrovirals.
Tenofovir disoproxil fumarate tablets should not be used in combination with other drugs containing tenofovir disoproxil fumarate or tenofovir alafenamide, including ATRIPLA®, COMPLERA®, DESCOVY®, GENVOYA®, ODEFSEY®, STRIBILD®, TRUVADA®, or VEMLIDY®. Tenofovir disoproxil fumarate should not be administered in combination with HEPSERA® (adefovir dipivoxil).
Due to the risk of development of HIV-1 resistance, tenofovir disoproxil fumarate should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen. Bone effects, including decreases in bone mineral density (BMD), increases in biochemical markers of bone metabolism, and mineralization defects, have been reported in association with the use of tenofovir disoproxil fumarate. Immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including tenofovir disoproxil fumarate.
Clinical trials in HIV-infected subjects have demonstrated that certain regimens that only contain three nucleoside reverse transcriptase inhibitors (NRTI) are generally less effective than triple drug regimens containing two NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor.
In clinical trials of adult subjects with HIV-1 infection, the most common adverse reactions (incidence greater than or equal to 10%, Grades 2 to 4) were rash, diarrhea, headache, pain, depression, asthenia, and nausea. Adverse reactions in pediatric subjects with HIV-1 infection were consistent with those observed in adults.
In clinical trials of adult subjects with chronic hepatitis B and compensated liver disease, the most common adverse reaction (all grades) was nausea (9%). In a clinical trial of adult subjects with chronic hepatitis B and decompensated liver disease, the most common adverse reactions (incidence greater than or equal to 10%, all grades) were abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia. Adverse reactions in pediatric subjects with chronic hepatitis B were consistent with those observed in adults.
For more information, please see accompanying Full Prescribing Information, including Boxed Warning.
Cautionary Note Regarding Forward-Looking Statements
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 ("Annual Report") and in our other filings with the U.S. Securities and Exchange Commission (the "SEC"). Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to rely on these forward-looking statements. You are advised to consult any additional disclosures we make in our reports to the SEC on Form 6-K, as well as the cautionary discussion of risks and uncertainties under "Risk Factors" in our Annual Report. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those listed could also materially and adversely affect us. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.
1 Viread® is a registered trademark of
Teva Pharmaceutical Industries Ltd.