FLAIR study meets primary endpoint, showing similar efficacy of a once-a-month, investigational, injectable two-drug regimen of cabotegravir and rilpivirine compared to a daily, oral three-drug, integrase-based regimen in virally-suppressed adults.
LONDON, UK I October 30, 2018 I ViiV Healthcare today announced positive headline results from its global, Phase III FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. FLAIR was designed to study if adults infected with human immunodeficiency virus type-1 (HIV-1), whose virus is suppressed after 20 weeks on the daily, oral medicine Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC), remain suppressed at a similar rate to continuing Triumeq after switching to a monthly two-drug intramuscular long-acting injectable regimen of cabotegravir and rilpivirine.
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm. Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.[i],[ii]
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said: “The FLAIR data provide further evidence that a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral therapy for people who have previously achieved viral suppression.This innovative dosing regimen could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12. Work on new methods of HIV treatment, including long-acting injectable therapies, supports our goal of making HIV a smaller part of the lives of people living with HIV.
Detailed results from the study will be presented at an upcoming scientific meeting.
FLAIR is ViiV Healthcare’s second, phase III clinical trial to examine the safety and efficacy of monthly dosing of injectable formulations of cabotegravir and rilpivirine. The ATLAS (Antiretroviral Therapy as Long Acting Suppression) study, for which positive headline data was reported in August, compares a long-acting, injectable regimen against the continuation of current daily oral antiretroviral therapy in virologically suppressed, treatment-experienced patients.[iii] ViiV Healthcare plans to use pooled data from the FLAIR and ATLAS studies for future regulatory submissions.
This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.
INDICATIONS AND USAGE
TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.
EDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
About GSK
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us.
[i] Margolis D A et al. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised phase 2b dose-ranging trial. The Lancet Infectious Diseases. Published online July 2015. Available at: http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00152-8/abstract Last accessed September 2018
[ii] Margolis, D. et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2):96-week results of a randomised, open-label, phase 2b, non-inferiority trial. The Lancet. July 2017. Published online: http://dx.doi.org/10.1016/S0140-6736(17)31917-7 Last accessed September 2018
[iii] https://clinicaltrials.gov/ct2/show/NCT03299049
SOURCE: GlaxoSmithKline
Post Views: 33
FLAIR study meets primary endpoint, showing similar efficacy of a once-a-month, investigational, injectable two-drug regimen of cabotegravir and rilpivirine compared to a daily, oral three-drug, integrase-based regimen in virally-suppressed adults.
LONDON, UK I October 30, 2018 I ViiV Healthcare today announced positive headline results from its global, Phase III FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. FLAIR was designed to study if adults infected with human immunodeficiency virus type-1 (HIV-1), whose virus is suppressed after 20 weeks on the daily, oral medicine Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC), remain suppressed at a similar rate to continuing Triumeq after switching to a monthly two-drug intramuscular long-acting injectable regimen of cabotegravir and rilpivirine.
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm. Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.[i],[ii]
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said: “The FLAIR data provide further evidence that a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral therapy for people who have previously achieved viral suppression.This innovative dosing regimen could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12. Work on new methods of HIV treatment, including long-acting injectable therapies, supports our goal of making HIV a smaller part of the lives of people living with HIV.
Detailed results from the study will be presented at an upcoming scientific meeting.
FLAIR is ViiV Healthcare’s second, phase III clinical trial to examine the safety and efficacy of monthly dosing of injectable formulations of cabotegravir and rilpivirine. The ATLAS (Antiretroviral Therapy as Long Acting Suppression) study, for which positive headline data was reported in August, compares a long-acting, injectable regimen against the continuation of current daily oral antiretroviral therapy in virologically suppressed, treatment-experienced patients.[iii] ViiV Healthcare plans to use pooled data from the FLAIR and ATLAS studies for future regulatory submissions.
This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.
INDICATIONS AND USAGE
TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.
EDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
About GSK
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us.
[i] Margolis D A et al. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised phase 2b dose-ranging trial. The Lancet Infectious Diseases. Published online July 2015. Available at: http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00152-8/abstract Last accessed September 2018
[ii] Margolis, D. et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2):96-week results of a randomised, open-label, phase 2b, non-inferiority trial. The Lancet. July 2017. Published online: http://dx.doi.org/10.1016/S0140-6736(17)31917-7 Last accessed September 2018
[iii] https://clinicaltrials.gov/ct2/show/NCT03299049
SOURCE: GlaxoSmithKline
Post Views: 33
