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|China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection|
- Genvoya is the First TAF-Based Regimen Approved in
Genvoya is indicated in
“With access to appropriate treatment, people living with HIV have the
potential to live nearly as long as the general population. Because of
this, they may face increased risk of age- and treatment-related
comorbidities, which means long-term health should be a priority when
caring for patients with HIV,” said Professor Li Taisheng,
In 2017, there were approximately 140,000 people newly diagnosed with
“Gilead supports China’s efforts to address the HIV epidemic and we are
pleased to offer Genvoya as a new treatment option for people living
with HIV in China,” said
Genvoya was studied in a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. The approval is supported by 144-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met the primary endpoint of non-inferiority compared to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or E/C/F/TDF) at Week 48. At Week 48, 92.4 percent (n=800/866) of patients taking Genvoya and 90.4 percent (n=784/867) of patients taking Stribild achieved HIV-1 RNA levels less than 50 copies/mL
Additionally, the approval is supported by a Phase 3 study (Study 109) evaluating Genvoya among virologically suppressed patients who switched from TDF-based regimens. The study enrolled 1,436 subjects and 1,196 had reached the 48-week time point at the time of filing. Among those patients, Genvoya was found to be statistically non-inferior to the TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL at Week 48. Patients receiving Genvoya also demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with the TDF-based regimens. Finally, data from Phase 3 studies evaluating Genvoya among adolescents and adults with mild-to-moderate renal impairment supported the approval.
Genvoya does not cure HIV infection or AIDS.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR GENVOYA IN U.S.
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
Pregnancy and Lactation
Genvoya is indicated in
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 Genvoya. 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
Genvoya and Stribild are registered trademarks of
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
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