– Biktarvy Showed High Efficacy and a Demonstrated Tolerability Profile Through 96 Weeks –
FOSTER CITY, CA, USA I October 3, 2018 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) through 96 weeks of therapy. The data will be presented during a late-breaking abstract session at the IDWeek 2018 conference in San Francisco.
“Healthcare providers who care for people living with HIV are always seeking treatment options that offer high efficacy, a high barrier to treatment-emergent resistance and a long-term tolerability profile,” said David Wohl, MD, Professor of Medicine, Division of Infectious Diseases, the University of North Carolina at Chapel Hill and lead study author. “This study underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy. In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”
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 or to replace the current antiretroviral regimen in those adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. No dosage adjustment of Biktarvy is required in adult patients with estimated creatinine clearance greater than or equal to 30 mL per minute. 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.
In Study 1489, treatment-naïve adults (n=629) were randomized 1:1 in a blinded fashion to receive Biktarvy (BIC/FTC/TAF) or ABC/DTG/3TC. At Week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 87.9 percent (n=276/314) of patients taking Biktarvy and 89.8 percent (n=283/315) of patients taking ABC/DTG/3TC achieving HIV-1 RNA levels less than 50 copies/mL (difference: -1.9 percent, 95 percent CI: -6.9 percent to 3.1 percent, p=0.45). In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance.
There were no renal discontinuations and no cases of proximal renal tubulopathy or Fanconi syndrome in the Biktarvy treatment group. The median change in estimated glomerular filtration rate (eGFR) from baseline to Week 96 was significantly less with Biktarvy compared with ABC/DTG/3TC (-7.8 mL/min vs. -9.6 mL/min, p=0.01). Median changes in proteinuria were similar between both treatment groups. Additionally, the mean percent changes from baseline in spine and hip bone mineral density in the Biktarvy group were similar to ABC/DTG/3TC group (spine: -0.71 vs. -0.22, p=0.14; hip: -1.13 vs. -1.26, p=0.59).
Biktarvy was well tolerated through Week 96. Discontinuations due to adverse events were low in both groups (0.0 percent (n=0) for Biktarvy vs. 2 percent (n=5) for ABC/DTG/3TC). The most commonly reported adverse events (all grades) were nausea (11 percent for Biktarvy vs. 24 percent for ABC/DTG/3TC), diarrhea (15 percent vs. 16 percent) and headache (13 percent vs. 16 percent).
“Gilead is committed to developing innovative treatments like Biktarvy that help address the unmet needs of people living with HIV,” said John McHutchison, AO, MD, Chief Scientific Officer, Gilead Sciences. “This study further supports the efficacy and resistance profiles of Biktarvy through 96 weeks. We look forward to presenting additional data that demonstrate the long-term utility of Biktarvy at upcoming scientific conferences.”
Study 1489 is ongoing and will remain randomized and blinded through 144 weeks.
Biktarvy does not cure HIV infection or AIDS.
INDICATION
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 more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
SOURCE: Gilead Sciences
Post Views: 18
– Biktarvy Showed High Efficacy and a Demonstrated Tolerability Profile Through 96 Weeks –
FOSTER CITY, CA, USA I October 3, 2018 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) through 96 weeks of therapy. The data will be presented during a late-breaking abstract session at the IDWeek 2018 conference in San Francisco.
“Healthcare providers who care for people living with HIV are always seeking treatment options that offer high efficacy, a high barrier to treatment-emergent resistance and a long-term tolerability profile,” said David Wohl, MD, Professor of Medicine, Division of Infectious Diseases, the University of North Carolina at Chapel Hill and lead study author. “This study underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy. In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”
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 or to replace the current antiretroviral regimen in those adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. No dosage adjustment of Biktarvy is required in adult patients with estimated creatinine clearance greater than or equal to 30 mL per minute. 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.
In Study 1489, treatment-naïve adults (n=629) were randomized 1:1 in a blinded fashion to receive Biktarvy (BIC/FTC/TAF) or ABC/DTG/3TC. At Week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 87.9 percent (n=276/314) of patients taking Biktarvy and 89.8 percent (n=283/315) of patients taking ABC/DTG/3TC achieving HIV-1 RNA levels less than 50 copies/mL (difference: -1.9 percent, 95 percent CI: -6.9 percent to 3.1 percent, p=0.45). In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance.
There were no renal discontinuations and no cases of proximal renal tubulopathy or Fanconi syndrome in the Biktarvy treatment group. The median change in estimated glomerular filtration rate (eGFR) from baseline to Week 96 was significantly less with Biktarvy compared with ABC/DTG/3TC (-7.8 mL/min vs. -9.6 mL/min, p=0.01). Median changes in proteinuria were similar between both treatment groups. Additionally, the mean percent changes from baseline in spine and hip bone mineral density in the Biktarvy group were similar to ABC/DTG/3TC group (spine: -0.71 vs. -0.22, p=0.14; hip: -1.13 vs. -1.26, p=0.59).
Biktarvy was well tolerated through Week 96. Discontinuations due to adverse events were low in both groups (0.0 percent (n=0) for Biktarvy vs. 2 percent (n=5) for ABC/DTG/3TC). The most commonly reported adverse events (all grades) were nausea (11 percent for Biktarvy vs. 24 percent for ABC/DTG/3TC), diarrhea (15 percent vs. 16 percent) and headache (13 percent vs. 16 percent).
“Gilead is committed to developing innovative treatments like Biktarvy that help address the unmet needs of people living with HIV,” said John McHutchison, AO, MD, Chief Scientific Officer, Gilead Sciences. “This study further supports the efficacy and resistance profiles of Biktarvy through 96 weeks. We look forward to presenting additional data that demonstrate the long-term utility of Biktarvy at upcoming scientific conferences.”
Study 1489 is ongoing and will remain randomized and blinded through 144 weeks.
Biktarvy does not cure HIV infection or AIDS.
INDICATION
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 more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
SOURCE: Gilead Sciences
Post Views: 18
