March 09, 2020
New Data on Gilead’s Biktarvy® Presented at CROI 2020, Including Data in Black Americans and Older Adults
– Phase 3 Data from the BRAAVE 2020 Study in Black or African American Virologically Suppressed Adults Presented, Including Patients with a History of Treatment Failure or Pre-Existing Resistance –
– Analysis of Separate Studies Shows Biktarvy is Effective and Well-Tolerated in Treatment-Naïve Adults 50 and Older, with No Significant Differences in Bone Density, Kidney Safety or Weight Over Three Years –
“As an African American I have experienced the impact of HIV in my community, family and friends. Importantly, as a front-line doctor treating a high percentage of persons of color with HIV, I am keenly aware of race-specific complications affecting Black Americans with HIV. However, less is known of the impact that race has on the efficacy and side effects of HIV medications,” said
Biktarvy is indicated in the
Gilead also announced results of a pooled analysis from two Phase 3 studies showing Biktarvy continued to be highly effective and well-tolerated in treatment-naïve patients age 50 and older over three years of treatment. Importantly, participants experienced no clinically significant differences in key measures such as bone density, renal laboratory markers or weight. These data from the two 144-week studies in treatment-naïve adults living with HIV will be presented at CROI 2020, in addition to results from an investigational study evaluating the efficacy, safety and pharmacokinetics of low-dose Biktarvy in pediatric patients.
“These data affirm once-daily Biktarvy as an effective choice for appropriate people switching treatment regimens, and as a well-tolerated first-line option that enables people over 50 living with HIV to sustain an undetectable viral load over the long-term,” said
Key abstracts for Biktarvy data presented at CROI 2020 include:
Oral 2979: Randomized Switch To B/F/TAF In African American Adults with HIV
In the BRAAVE 2020 study, adults (495) who self-identified as Black or
The study showed noninferior antiviral efficacy for people switching to Biktarvy from a variety of regimens, including in patients with pre-existing NRTI resistance. At Week 24, 96.3 percent of study participants treated with Biktarvy and 94.5 percent of study participants who stayed on their baseline regimen maintained viral suppression, with no treatment-emergent resistance detected. The most common adverse events (AEs) in the study were headache, diarrhea and insomnia. Most treatment-related AEs were grade 1. AEs leading to study drug discontinuation occurred in 1.8 percent of patients receiving Biktarvy and 0 percent remaining on their baseline regimen.
Poster 2886: 144-Week Efficacy and Safety Of B/F/TAF In Treatment-Naive Adults ≥50 Yrs
The double-blind Phase 3 studies 1489 and 1490 randomized 1274 treatment-naïve adults to assess the safety and efficacy of Biktarvy. Study 1489 evaluated Biktarvy compared to dolutegravir, abacavir, and lamivudine (DTG/
At Week 144, Biktarvy was found to be highly effective and well-tolerated in adults age 50 or older, with no clinically significant differences in bone density or renal safety, fasting lipids or weight gain from baseline. Across treatment groups, the most common adverse events in patients age 50 and older were nasopharyngitis, diarrhea and upper respiratory tract infection, and most treatment-related AEs were grade 1. AEs leading to study drug discontinuation for participants age 50 and older occurred in 2 percent of patients receiving Biktarvy, compared to 5 percent receiving DTG/
Study 1489 and Study 1490 are ongoing. Beyond Week 144, study participants will have the option to receive Biktarvy in an open-label extension for up to 96 weeks.
Gilead will also present additional Biktarvy clinical development program data on
Biktarvy does not cure HIV infection or AIDS.
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.
- Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
- Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including
FTCand TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
- Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
- Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of
FTCand tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
- Renal impairment: Not recommended in patients with CrCl <30 mL/min.
- Hepatic impairment: Not recommended in patients with severe hepatic impairment.
- Prior to or when initiating: Test patients for HBV infection.
- Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.
Pregnancy and lactation
Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for
FTCshows no difference in the rates of birth defects compared with a US reference population.
- Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Biktarvy.
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.
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 Biktarvy, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all. 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 Annual Report on Form 10-K for the year ended
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