Date: 06-Oct-2020

Teva Launches First Generic Versions Of HIV-1 Treatments TRUVADA® Emtricitabine 200 Mg Tenofovir Disoproxil Fumarate 300 Mg And ATRIPLA® Efavirenz 6

TEL AVIV & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva PharmaceuticalsUSA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the availability of the first Food and Drug Administration (FDA)-approved generic versions of TRUVADA®i and ATRIPLA®i tablets.

“As the global leader in producing and supplying generics, Teva is excited to launch these medications which further our commitment to delivering more treatment options to patients,” said Brendan O’Grady, Executive Vice President, North America Commercial, Teva. “These products, in addition to our more than 10 HIV-related medications already on the World Health Organization’s Essential Medicines list, represent Teva’s continued pursuit of treatments for HIV to improve health outcomes for the HIV community. During the COVID-19 pandemic, access to treatment is more essential than ever for those who are immunocompromised and at risk of developing more severe disease.”

With 1.2 million people currently living with HIV-1 in the U.S., Teva is committed to increasing access to critical HIV therapies.ii Despite significant advances in the treatment and prevention of HIV over the last two decades, there are still 12.6 million people globally who are unable to obtain treatment today.iii With the introduction of these new generic HIV treatment options, Teva strives to further increase access to important therapies.

These newly available generic medicines are indicated for:

  • Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:
    • Treatment of HIV-1 infection when used with other anti-HIV-1 medicines in adults and children who weigh at least 37 pounds (at least 17 kilograms)
    • HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (at least 35 kilograms)
  • Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:
    • Treatment of HIV-1 infection in people who weigh at least 88 pounds (40 kilograms), alone as a complete regimen, or in combination with other anti-HIV-1 medicines

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are both combination treatments available as a single pill with similar safety profiles to their reference products.

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are expected to be available through retailers and wholesalers at a Wholesale Acquisition Cost (WAC) of $48.51 per tablet. Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are expected to be available through retailers and wholesalers at a WAC of $78.86 per tablet. Actual costs to individual patients and providers are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program. More information is available at TevaHIVgenerics.com.

Emtricitabine 200 Mg/Tenofovir Disoproxil Fumarate 300 Mg

IMPORTANT SAFETY INFORMATION

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PRE­EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

 

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine and tenofovir disoproxil fumarate tablets. If appropriate, anti-hepatitis B therapy may be warranted.

 

Emtricitabine and tenofovir disoproxil fumarate tablets used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

Contraindications: Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.

Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection: All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating emtricitabine and tenofovir disoproxil fumarate tablets. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Individuals infected with HBV who discontinue emtricitabine and tenofovir disoproxil fumarate tablets should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.

Comprehensive Management to Reduce the Risk of Sexually Transmitted Infections, Including HIV-1, and Development of HIV-1 Resistance When Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Is Used for HIV-1 PrEP: Use emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes other prevention measures, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). The time from initiation of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown.