– Long-term data from the Phase 2b LATTE-2 study demonstrated comparable antiviral activity to daily, oral 3-drug combination –
– Data presented as an oral late breaker at the 9th International AIDS Society Conference, 23-26 July 2017, Paris, France –
CORK, Ireland I July 24, 2017 I Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced that a regimen of two investigational long-acting, injectable formulations of HIV medicines —Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir — given together every 4 or 8 weeks was as effective as 3-drug oral antiretroviral therapy (ART) at maintaining HIV-1 viral suppression through 96 weeks (HIV-1 RNA <50 copies per mL). Results published in The Lancet show that if approved, this first two-drug, long-acting regimen could offer a highly effective suppressive maintenance therapy for people living with HIV.
Viral suppression was achieved in 94 percent of those (n=108) receiving injections every eight weeks, warranting further investigation. Virologic response was also achieved by 87 percent (n=100) of those receiving injections every four weeks versus 84 percent (n=47) receiving oral ART therapy. In an unprecedented outcome, no virologic non-responders to the long-acting regimen were observed in the four-week group, as determined by the stringent FDA snapshot algorithm. Few virologic non-responders were seen in the eight-weekly group (n=5 [4%]). These results highlighted that the two-drug, long-acting regimen offered durability of virologic response throughout almost 2 years of treatment.
“Results published in The Lancet strengthen the evidence that a two-drug, long-acting regimen may offer an effective and acceptable alternative for people who have achieved viral suppression but struggle with daily, oral regimens to control their HIV,” said Paul Stoffels M.D., Chief Scientific Officer, Johnson & Johnson. “Non-adherence to treatment remains a challenge for many people living with HIV and one of the main drivers of resistance to HIV medicines. Our hope is to make HIV treatment manageable for all by developing innovative solutions like long-acting regimens.”
In LATTE-2, patients with HIV-1 viral suppression on oral medication (cabotegravir plus abacavir/lamivudine) were randomized 2:2:1 to long-acting injections every four or eight weeks, or to daily oral cabotegravir taken with abacavir and lamivudine.
High satisfaction was reported in the study by those receiving the two-drug, long-acting regimen, which suggests it may provide a preferred alternative for many people living with HIV who may not wish to consider taking life-long oral therapy. The data are based on the observed case data set of subjects who completed questionnaires at week 48 and week 96.
The two-drug, long-acting regimen was generally well tolerated, with no drug-related serious adverse events and few adverse event-related withdrawals. While injection-site reactions (ISRs) were common (four-weekly group, 97% of patients; eight-weekly group, 96% of patients), they were transient in nature, and mild or moderate in severity. The long-term acceptability of administering chronic intramuscular injections to patients was also demonstrated in LATTE-2, with very few withdrawals resulting from ISRs (two patients [<1%]), through 96 weeks.
The most commonly reported non-ISR adverse events were nasopharyngitis (four-weekly group, 34%; eight-weekly group, 30%; oral cabotegravir plus abacavir/lamivudine groups, 39%), diarrhea (four-weekly group, 28%; eight-weekly group, 23%; oral cabotegravir plus abacavir/lamivudine group, 20%), and headache (four-weekly group, 23%; eight-weekly group, 25%; oral cabotegravir plus abacavir/lamivudine group, 25%).
Two global Phase 3 switch studies, FLAIR (First Long-Acting Injectable Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression), are currently examining the safety and efficacy of four weekly dosing with the two-drug, injectable regimen. For more information on the clinical trials, please visit: www.clinicaltrials.gov.
These results will be presented in an oral abstract session at the 9th International AIDS Society Conference on HIV Science (IAS 2017) at 12:00 on Monday 24 July 2017. Please visit jnj.com/HIV for additional details on the breadth of science being presented by Johnson & Johnson companies and its partners.
###
About the LATTE 2 clinical trial (NCT02120352)
LATTE-2 is an ongoing Phase 2b, multicenter, parallel group, and open-label study which recruited ART-naïve HIV-infected adults. Enrolled patients who had a plasma HIV-1 RNA, <50 c/mL during 20-week Induction Period (IP) with daily oral cabotegravir (CAB) 30 mg plus abacavir/lamivudine 600 mg/300 mg were randomized 2:2:1 to intramuscular injections every 4 weeks (long-acting cabotegravir 400 mg plus rilpivirine 600 mg; two 2-mL injections) or every 8 weeks (long-acting cabotegravir 600 mg plus rilpivirine 900 mg; two 3-mL injections), or to continue receiving three-drug, oral ART in the Maintenance Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot algorithm, protocol defined virologic failure, and safety at 32 weeks in the maintenance period. Antiviral activity, protocol-defined virologic failures and safety events through 96 weeks for the maintenance population were key secondary endpoints.
About cabotegravir
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare as a long-acting, nanosuspension formulation for intramuscular injection for the treatment and prevention of HIV.
About EDURANT® (Rilpivirine)
EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients:
- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load.
EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.
About Janssen
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us at @JanssenGlobal.
SOURCE: Janssen
Post Views: 22
– Long-term data from the Phase 2b LATTE-2 study demonstrated comparable antiviral activity to daily, oral 3-drug combination –
– Data presented as an oral late breaker at the 9th International AIDS Society Conference, 23-26 July 2017, Paris, France –
CORK, Ireland I July 24, 2017 I Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced that a regimen of two investigational long-acting, injectable formulations of HIV medicines —Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir — given together every 4 or 8 weeks was as effective as 3-drug oral antiretroviral therapy (ART) at maintaining HIV-1 viral suppression through 96 weeks (HIV-1 RNA <50 copies per mL). Results published in The Lancet show that if approved, this first two-drug, long-acting regimen could offer a highly effective suppressive maintenance therapy for people living with HIV.
Viral suppression was achieved in 94 percent of those (n=108) receiving injections every eight weeks, warranting further investigation. Virologic response was also achieved by 87 percent (n=100) of those receiving injections every four weeks versus 84 percent (n=47) receiving oral ART therapy. In an unprecedented outcome, no virologic non-responders to the long-acting regimen were observed in the four-week group, as determined by the stringent FDA snapshot algorithm. Few virologic non-responders were seen in the eight-weekly group (n=5 [4%]). These results highlighted that the two-drug, long-acting regimen offered durability of virologic response throughout almost 2 years of treatment.
“Results published in The Lancet strengthen the evidence that a two-drug, long-acting regimen may offer an effective and acceptable alternative for people who have achieved viral suppression but struggle with daily, oral regimens to control their HIV,” said Paul Stoffels M.D., Chief Scientific Officer, Johnson & Johnson. “Non-adherence to treatment remains a challenge for many people living with HIV and one of the main drivers of resistance to HIV medicines. Our hope is to make HIV treatment manageable for all by developing innovative solutions like long-acting regimens.”
In LATTE-2, patients with HIV-1 viral suppression on oral medication (cabotegravir plus abacavir/lamivudine) were randomized 2:2:1 to long-acting injections every four or eight weeks, or to daily oral cabotegravir taken with abacavir and lamivudine.
High satisfaction was reported in the study by those receiving the two-drug, long-acting regimen, which suggests it may provide a preferred alternative for many people living with HIV who may not wish to consider taking life-long oral therapy. The data are based on the observed case data set of subjects who completed questionnaires at week 48 and week 96.
The two-drug, long-acting regimen was generally well tolerated, with no drug-related serious adverse events and few adverse event-related withdrawals. While injection-site reactions (ISRs) were common (four-weekly group, 97% of patients; eight-weekly group, 96% of patients), they were transient in nature, and mild or moderate in severity. The long-term acceptability of administering chronic intramuscular injections to patients was also demonstrated in LATTE-2, with very few withdrawals resulting from ISRs (two patients [<1%]), through 96 weeks.
The most commonly reported non-ISR adverse events were nasopharyngitis (four-weekly group, 34%; eight-weekly group, 30%; oral cabotegravir plus abacavir/lamivudine groups, 39%), diarrhea (four-weekly group, 28%; eight-weekly group, 23%; oral cabotegravir plus abacavir/lamivudine group, 20%), and headache (four-weekly group, 23%; eight-weekly group, 25%; oral cabotegravir plus abacavir/lamivudine group, 25%).
Two global Phase 3 switch studies, FLAIR (First Long-Acting Injectable Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression), are currently examining the safety and efficacy of four weekly dosing with the two-drug, injectable regimen. For more information on the clinical trials, please visit: www.clinicaltrials.gov.
These results will be presented in an oral abstract session at the 9th International AIDS Society Conference on HIV Science (IAS 2017) at 12:00 on Monday 24 July 2017. Please visit jnj.com/HIV for additional details on the breadth of science being presented by Johnson & Johnson companies and its partners.
###
About the LATTE 2 clinical trial (NCT02120352)
LATTE-2 is an ongoing Phase 2b, multicenter, parallel group, and open-label study which recruited ART-naïve HIV-infected adults. Enrolled patients who had a plasma HIV-1 RNA, <50 c/mL during 20-week Induction Period (IP) with daily oral cabotegravir (CAB) 30 mg plus abacavir/lamivudine 600 mg/300 mg were randomized 2:2:1 to intramuscular injections every 4 weeks (long-acting cabotegravir 400 mg plus rilpivirine 600 mg; two 2-mL injections) or every 8 weeks (long-acting cabotegravir 600 mg plus rilpivirine 900 mg; two 3-mL injections), or to continue receiving three-drug, oral ART in the Maintenance Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot algorithm, protocol defined virologic failure, and safety at 32 weeks in the maintenance period. Antiviral activity, protocol-defined virologic failures and safety events through 96 weeks for the maintenance population were key secondary endpoints.
About cabotegravir
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare as a long-acting, nanosuspension formulation for intramuscular injection for the treatment and prevention of HIV.
About EDURANT® (Rilpivirine)
EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients:
- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load.
EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.
About Janssen
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us at @JanssenGlobal.
SOURCE: Janssen
Post Views: 22
