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|U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection|
– Gilead’s First TAF-based Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens –
Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA levels less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya. No dosage adjustment of Genvoya is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
Genvoya has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. Further important safety information, adverse drug reactions and drug interactions are listed below.
Photos and multimedia gallery available at www.GileadHIVMedia.com.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91 percent less tenofovir in the bloodstream.
“As the HIV patient population ages there is an increased risk for
development of age- and treatment-related comorbidities, including low
bone mineral density and renal impairment. This is due to the
combination of HIV infection, antiretroviral treatments and the natural
aging process,” 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 48-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met its primary objective of non-inferiority compared to Stribild® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies, 92.4 percent of Genvoya patients and 90.4 percent of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Tests of certain renal and bone laboratory parameters also favored Genvoya over Stribild.
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 patients with mild-to-moderate renal impairment supported the approval.
“While exceptional progress has been made in the field of HIV, there is
still a need for new treatment options that may help improve the health
of people as they grow older with the disease,” said
Two other TAF-based regimens are currently under evaluation by the
F/TAF and R/F/TAF are investigational products and have not been determined to be safe or efficacious.
Genvoya does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance to patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Genvoya.
The program offers support services for patients and providers, including:
Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Genvoya for patients who receive medications through these programs.
Information about how to apply for any of these forms of assistance can
be found at www.GileadAdvancingAccess.com
or by calling 1-800-226-2056
Important U.S. Safety Information for Genvoya
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
Pregnancy and breastfeeding
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. In
addition, marketing authorizations for F/TAF and R/F/TAF may not be
approved by the
Genvoya, Stribild, Truvada and Viread are registered trademarks of
For more information on
Gilead Sciences, Inc.
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