China National Medical Products Administration Approves Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

-- Truvada is the First HIV PrEP Medicine Approved in China --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF). In China, Truvada for PrEP^® is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Truvada for PrEP should be taken once daily and used together with safer sex practices. Individuals must have a negative HIV-1 test immediately prior to initiating Truvada for PrEP.

Truvada is the first medicine approved for HIV prevention in China. Previously, Truvada was approved in combination with other antiretroviral medicines as a treatment for HIV-1 infection in adults and pediatric patients 12 years of age and older.

According to data published by the China National Health Commission (NHC) in November 2019, 131,000 new HIV infections were reported between January and October 2019 in China. Among the newly reported cases, sexual transmission was the main mode of transmission. In addition to safer sex practices and using condoms correctly, the World Health Organization (WHO) recommends offering PrEP to all groups at substantial risk of HIV infection as part of a comprehensive HIV prevention plan.

“The approval of Truvada for PrEP addresses an area of significant unmet need in the field of HIV prevention medicine in China. It provides a new prevention option with a demonstrated safety and efficacy profile,” said Professor Zhang Fujie, Director of Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University. “Truvada for PrEP could play an important role in our response to the HIV epidemic and may help reduce the number of new HIV infections in China.”

The approval of Truvada for PrEP was supported by data from two randomized, double-blind, placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP. The iPrEx trial included 2,499 HIV-seronegative men and transgender women who have sex with men and the Partners PrEP trial included 4,758 HIV-1 serodiscordant heterosexual couples. In total, 2,834 HIV-1 uninfected adults received Truvada. The number of new HIV-1 seroconversions was significantly lower among those who received Truvada compared to those in the placebo group.

The efficacy of Truvada for PrEP was strongly associated with adherence. The most commonly reported adverse events among the individuals taking Truvada were headache, abdominal pain and weight decrease.

“Gilead is committed to delivering innovative therapeutics to help address unmet medical needs in China. Since launching our operations in China in 2017, we have introduced a number of HIV treatments for people living with HIV. With the inclusion of our HIV medicines in the 2019 National Reimbursement Drug List (NRDL), we are hopeful that access to treatments among people in need will be increased significantly,” said Rogers Luo, Vice President & China General Manager, Gilead Sciences. “With the approval of Truvada for PrEP, Gilead is now able offer options for PrEP and treatment – as we strive to help people living with and at risk of acquiring HIV and to partner with the government and healthcare community to improve public health in China.”

In the United States, Truvada for PrEP is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV-negative status must be confirmed immediately prior to initiation. Truvada has a Boxed Warning in its U.S. product label regarding the risk of drug resistance when used for PrEP in undiagnosed early HIV infection, and the risk of post-treatment acute exacerbation of hepatitis B. Please see below for U.S. Indication and Important Safety Information.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For nearly 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.

Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.

About PrEP

PrEP is an HIV prevention strategy in which medicine is taken daily before an HIV-negative person may be exposed to the virus through sex to help reduce the risk of infection. PrEP is highly effective at reducing the risk of HIV infection in at-risk populations.

Prevention methods, including PrEP, and safer sex practices are essential tools in the effort to end the HIV epidemic. PrEP use received an “A” rating from the U.S. Preventive Services Task Force (USPSTF), signifying that PrEP has a high certainty of substantial preventive benefits for reducing the risk of HIV. In addition, PrEP is recommended by the U.S. Centers for Disease Control and Prevention, the WHO and other national healthcare organizations as part of a comprehensive prevention strategy for individuals at risk for HIV.

U.S. Important Safety Information for Truvada for PrEP

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Truvada for PrEP must be prescribed only to patients confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of Truvada for PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed.
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who have HBV infection and discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindication

Truvada for PrEP is contraindicated in patients with unknown or positive HIV status.

Warnings and precautions

Comprehensive management to reduce risks:
- Use Truvada for PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
- HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network.
- Reduce STI risk:Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 status, including viremic status, regular testing for STIs).
- Reduce potential for drug resistance: Only prescribe Truvada for PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking Truvada, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only Truvada because Truvada alone is not a complete regimen for treating HIV-1.
- Some HIV tests may not detect acute HIV infection. Prior to initiating Truvada for PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection.
- If HIV-1 infection is suspected or if symptoms of acute infection are present while taking Truvada for PrEP, convert the Truvada for PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection.
- Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling.

Warnings and precautions

New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of TDF. Truvada is not recommended in patients with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high-dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients (see Dosage and Administration section).
Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including Truvada. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of Truvada, and monitor for adverse reactions.

Adverse reactions

Common adverse reactions (>2% and more frequently than placebo) of Truvada for PrEP in clinical trials were headache, abdominal pain, and weight loss.

Drug interactions

Prescribing information: Consult the full Prescribing Information for Truvada for more information, warnings, and potentially significant drug interactions, including clinical comments.
Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions.
Drugs affecting renal function: Coadministration of Truvada with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir.

Pregnancy and lactation

Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no significant difference in the rate of major birth defects for Truvada compared with a US reference population. Consider HIV prevention methods, including Truvada for PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother-to-child transmission during acute HIV-1 infection.
Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of Truvada for PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of Truvada on the child, which are unknown.

Dosage and administration

Dosage: One tablet, once daily, with or without food.
HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment.
HBV screening: Test for HBV infection prior to or when initiating treatment.
Renal impairment and monitoring: Not recommended in patients with CrCl <60 mL/min. Prior to or when initiating Truvada, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

U.S. Indication for Truvada for PrEP

Truvada for PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV. HIV-negative status must be confirmed immediately prior to initiation.

Forward-Looking Statements

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 Truvada for PrEP and the risk that individuals may not maintain adherence to daily dosing of Truvada for PrEP. There is also the possibility of unfavorable results from ongoing and additional clinical trials involving Truvada for PrEP. 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 June 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.

U.S. Prescribing Information for Truvada, including BOXED WARNING, is available at www.gilead.com.

Truvada, Truvada for PrEP, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200811005498/en/

Douglas Maffei, PhD, Investors (650) 522-2739

Larkin Callaghan, Media (650) 425-5078

Maggie Ma, Media - China +86 21 3893 4556

Source: Gilead Sciences, Inc.