-- PrEP is part of the ongoing efforts by
DESCOVY is indicated for PrEP to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ≥ 35 kg, excluding individuals at risk from receptive vaginal sex. DESCOVY is taken orally once daily with or without food. DESCOVY is also approved in Canada for the treatment of HIV-1 infection in adults and pediatric patients weighing ≥ 25 kg, in combination with other antiretroviral agents.1
PrEP – Reducing the Risk of Acquiring HIV
PrEP is an HIV prevention strategy to reduce the risk of acquiring HIV infection. It can be taken by HIV-negative individuals considered at high risk of infection. PrEP is taken daily, on an ongoing basis, in advance of high-risk activity. According to the Public Health Agency of Canada, when medication for PrEP is taken as prescribed, the medication reduces the risk of acquiring sexually transmitted HIV by more than 90 per cent.2
Before prescribing DESCOVY for PrEP™, healthcare providers must counsel all uninfected individuals to strictly adhere to the recommended DESCOVY dosing schedule and must screen all individuals for HIV-1 immediately prior to initiating DESCOVY for PrEP and at least once every three months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections.1
Canadian Experts Involved in DESCOVY for
"Data have shown that when used in combination with other agents for HIV treatment, DESCOVY offers similar efficacy and improved safety for renal and bone parameters compared with TRUVADA," said Dr.
The PrEP indication is based on data from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial that evaluated the safety and efficacy of DESCOVY for PrEP compared with that of Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in reducing the risk of acquiring HIV-1 infection. Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women who have sex with men.
"DESCOVY for PrEP provides a new HIV prevention option that has demonstrated high efficacy and statistically significant improvements in renal and bone safety," said Melissa Koomey, Vice President and General Manager, Gilead Canada. "As an important public health strategy, PrEP can help to reduce HIV infections. As such,
HIV in
According to the most recent HIV data from the
In 2018, a total of 2,561 HIV diagnoses (new cases) were reported in
Important Safety Information for DESCOVY for HIV Treatment and PrEP1
DESCOVY does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
The DESCOVY Product Monograph includes a Serious Warnings and Precautions Box:
Post-treatment Exacerbation of Hepatitis B Virus: DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of DESCOVY have not been established in individuals infected with HBV. Discontinuation of DESCOVY therapy in individuals infected with HBV may be associated with severe acute exacerbations of hepatitis due to the emtricitabine (FTC) or tenofovir alafenamide (TAF) components of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals infected with HBV who discontinue DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Risk of Drug Resistance with Use of DESCOVY for HIV-1 PrEP in Undiagnosed Early HIV-1 Infection: DESCOVY 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
The safety and efficacy of DESCOVY for HIV-1 PrEP in individuals at risk from receptive vaginal sex have not been studied.
DESCOVY should not be coadministered with products containing any of the same components, or with products containing lamivudine or tenofovir disoproxil fumarate. In addition, DESCOVY should not be administered with adefovir dipivoxil.
For all important safety information for DESCOVY, including contraindications, additional warnings and precautions, adverse reactions and drug interactions, please see the Canadian Product Monograph at www.gilead.ca.
About
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it's estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's manufacturing partners.
For more information on Gilead Sciences, Inc., please visit the company's website at www.gilead.com.
Forward-Looking Statement
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 possibility of unfavorable results from ongoing and additional clinical trials involving DESCOVY for PrEP. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. 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 September 30, 2020 as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Canadian Product Monographs for DESCOVY and TRUVADA, including Serious Warnings and Precautions, are available at www.gilead.ca.
DESCOVY, DESCOVY for PrEP, TRUVADA, TRUVADA for PrEP and Gilead are trademarks of
For more information on
1-800-GILEAD-5 or 1-650-574-3000.
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1. | DESCOVY Product Monograph. |
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© Canada Newswire, source