Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance
- Category: Small Molecules
- Published on Thursday, 07 March 2019 09:29
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FOSTER CITY, CA, USA I March 06, 2019 I Gilead Sciences, Inc. (NASDAQ: GILD) today announced data from two studies evaluating the resistance profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF) in virologically suppressed adults switching from dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or a boosted protease inhibitor (PI)-based regimen for the treatment of HIV-1. The studies found high rates of virologic suppression with Biktarvy in treatment-experienced adults, regardless of pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs). The data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history. Biktarvy is also indicated to replace the current antiretroviral regimen in those adults who are virologically suppressed on a stable antiretroviral regimen for at least three months. Virologically suppressed adults must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy carries a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.
“Maintaining virologic suppression, even in the setting of resistance to certain classes of HIV medicines, when switching to Biktarvy, speaks to the versatility of Biktarvy,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “These data add to the growing body of evidence supporting Biktarvy as a single tablet regimen that can be used in a wide range of clinical settings.”
Key abstracts for data presented at the conference included:
Poster 2141: Long-Term Biktarvy Switch Efficacy in Patients with Archived Pre-Existing Resistance
Participants in two Phase 3 Biktarvy switch studies (Studies 1844 and 1878) were followed through two years of therapy in the open-label continuation of these studies past the Week 48 primary endpoints. Documented resistance to study drugs was exclusionary; for the purposes of this retrospective analysis, archived preexisting HIV-1 drug resistance was assessed by historical genotypes and retrospective baseline proviral DNA genotyping. Among adults who switched to Biktarvy from DTG/ABC/3TC or a boosted protease inhibitor (PI)-based regimen, high rates of virologic suppression were observed in the overall population (n=561/570; 98 percent) as well as the population with preexisting drug resistance (n=155/159; 97 percent), including those with archived M184V/I (n=42/44; 95 percent). No patients developed treatment-emergent resistance during the course of the study.
Poster 3362: High Level of Pre-Existing NRTI Resistance Prior to Switching to Biktarvy
This ongoing, randomized, double-blind Phase 3 study (Study 4030) evaluated 565 virologically suppressed adults who switched 1:1 from a regimen of DTG+F/TAF or DTG+F/TDF to DTG+F/TAF or Biktarvy for 48 weeks. Participants with any documented nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse-transcriptase inhibitor (NNRTI), and protease inhibitor (PI) resistance were allowed to enroll; patients with documented INSTI resistance were excluded. Archived preexisting HIV-1 drug resistance was assessed by historical genotype and retrospective baseline proviral DNA genotyping. In the study, 14 percent (n=78/565) of participants had NRTI resistance known or suspected at screening. This increased to 24 percent (n=138/565) using historical data combined with additional baseline proviral HIV-1 DNA genotyping. In this pooled, blinded interim analysis, 99 percent (n=557/562) of all participants with any post-baseline visit and 99 percent (n=220/222) of participants with resistance to any class of ARV, including those with archived M184V/I (n=79/81; 98 percent), had undetectable viral load (HIV-1 RNA <50 copies/mL) with no emergent drug resistance.
The efficacy and safety profile of Biktarvy in patients with preexisting resistance to its components has not been established; its use in these populations is investigational. Biktarvy does not cure HIV infection or AIDS.
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults 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 for ≥3 months with no history of treatment failure and no known resistance to any component of Biktarvy.
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 11.5 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, please visit the company’s website at www.gilead.com.
SOURCE: Gilead Sciences