July 16, 2012
U.S. Food and Drug Administration Approves Gilead’s Truvada® for Reducing the Risk of Acquiring HIV
– First Agent Indicated for Uninfected Adults at High Risk of Acquiring HIV Through Sex –
“Today’s decision is the culmination of almost 20 years of research
involving investigators, academic and medical institutions, funding
agencies and nearly 20,000 trial participants around the world, and
Gilead is proud to have been a partner in this effort,” said
It is estimated that 1.2 million Americans are currently living with HIV, and, despite the availability of existing prevention tools such as condoms, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. Nearly one-quarter (23 percent) of new HIV cases occur among women, and more than half (61 percent) occur among men who have sex with men (MSM). In particular, young African American MSM bear a heavy burden of the epidemic, with new HIV cases among this group increasing by nearly 50 percent between 2006 and 2009.
Data supporting the approval of Truvada for PrEP came primarily from two
large placebo-controlled trials known as the Pre-Exposure Prophylaxis
Initiative (iPrEx), sponsored by the
“This approval is a major milestone in our 30-year fight against AIDS,”
Based on the iPrEx results, in
“The data clearly demonstrate that Truvada as pre-exposure prophylaxis
is effective at reducing the risk of HIV infection acquired through
sexual exposure,” said Connie Celum, MD, MPH, Professor of Global Health
and Medicine at the
As part of the REMS developed by Gilead and
As a separate measure to support the safe use of Truvada for PrEP, Gilead also will provide vouchers for free HIV testing and condoms, an opt-in service for regular reminders about HIV testing and subsidized HIV resistance testing for any individual who becomes HIV-positive while taking Truvada for PrEP.
In all studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as an HIV treatment, which is supported by more than four million years of patient use. Overall, there have been nearly nine million patient years of experience with tenofovir-containing regimens.
Important Safety Information about Truvada:
WARNINGS: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread®, a component of Truvada, in combination with other antiretrovirals.
Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Truvada used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically during use. Drug-resistant HIV-1 variants have been identified with use for Truvada for a PrEP indication following undetected acute HIV-1 infection. Do not initiate Truvada for a PrEP indication if signs and symptoms of acute HIV infection are present unless a negative infection status is confirmed.
Do not use Truvada for pre-exposure prophylaxis in individuals with unknown or positive HIV status. Truvada should be used in HIV-infected patients only in combination with other antiretroviral agents.
New onset or worsening of renal impairment may occur, including acute renal failure and Fanconi Syndrome. Creatinine clearance should be calculated prior to administering Truvada. Truvada for HIV-1 infection should not be used in patients with severe renal disease (CrCl < 30 mL/min), and routine monitoring of CrCl and serum phosphorous all patients at risk for renal impairment is recommended. Avoid administering concurrently with or with recent use of nephrotoxic drugs.
- Do not use Truvada for pre-exposure prophylaxis in individuals with a creatinine clearance (CrCl) below 60 mL/min. Re-assess risk and benefits of using Truvada for PrEP if a decrease in CrCL is observed during use for PrEP.
Decreases in Bone Mineral Density (BMD) may occur. Consider assessing BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. Fat Redistribution has also been observed in patients receiving antiretroviral therapy. Immune Reconstitution Syndrome may occur in HIV-1-infected patients. Autoimmune disorder may occur in the setting of Immune Reconstitution.
Truvada for a PrEP indication:
Comprehensive Management to Reduce the Risk of Acquiring HIV: Truvada for PrEP should only be used as part of a comprehensive prevention strategy that includes other prevention measures such as safer sex practices. A comprehensive prevention strategy includes consistent and correct use of condoms, the individual knowing both their and their partner’s HIV status, getting regular testing for HIV and other sexually transmitted infections, and informing individuals about and supporting their efforts to reduce sexual risk behavior.
Use Truvada for PrEP to reduce the risk of acquiring HIV-1 only in
individuals confirmed to be HIV negative because HIV-1 resistance
substitutions may emerge. HIV-1 negative status must be confirmed
immediately prior to prescribing and regularly thereafter (at least
every three months). Defer initiating Truvada for PrEP if clinical signs
and symptoms of acute HIV-1 infection are present or if recent exposure
(< 1 month) is suspected, or confirm HIV-1 negative status using a test
approved by the
Truvada for use with other antiretroviral agents to treat HIV-1 infection: Truvada should not be co-administered with any other antiretroviral agents for HIV that contain emtricitabine or tenofovir disoproxil fumarate, nor should it be co-administered with products containing lamivudine. Do not administer with Hepsera.
Common side effects reported during clinical studies with Truvada (in combination with efavirenz) include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash.
In clinical trials for Truvada for PrEP, the most common side effects associated with Truvada were headache, stomach discomfort and weight loss. Caution should be exercised when co-administering Truvada with didanosine, atazanavir and lopinavir/ritonavir due to the potential for toxicity.
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
risks that physicians and patients may be reluctant to use Truvada for
HIV risk reduction. As a result, there may not be significant use of
Truvada as a risk reduction tool. 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
Truvada is a registered trademark of
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Cara Miller, 650-522-1616 (Media)