KENILWORTH, NJ, USA I October 04, 2018 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new results from the Phase 3 DRIVE-AHEAD clinical trial evaluating the efficacy and safety of DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in treatment-naïve adults with HIV-1 infection. The efficacy findings at Week 96 in DRIVE-AHEAD were consistent with the findings at Week 48 in which DELSTRIGO demonstrated non-inferior efficacy in comparison to a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg). The pivotal Phase 3, Week 48 data were previously presented at the 9th IAS Conference on HIV Science / IAS 2017.
The new Week 96 findings will be presented today as a late-breaking oral presentation at IDWeek 2018 taking place Oct. 3-7, 2018, in San Francisco.
“Long-term data from this pivotal clinical trial further confirm the efficacy and safety of DELSTRIGO in treatment-naïve patients,” said Dr. Jean-Michel Molina, Professor of Infectious Diseases, University of Paris, and Head of the Infectious Diseases Department at Saint-Louis Hospital in Paris, France. “The data position this fixed-dose combination as a new treatment option that can address the needs of people living with HIV today.”
Data from DRIVE-AHEAD
In DRIVE-AHEAD, 728 participants with no antiretroviral treatment history were randomized and received at least one dose of either DELSTRIGO or EFV/FTC/TDF once daily. In this trial, after 96 weeks of treatment, the proportion of participants achieving plasma HIV-1 RNA levels less than 50 copies/mL was 77.5 percent in the group treated with DELSTRIGO (doravirine/3TC/TDF) and 73.6 percent in the group treated with EFV/FTC/TDF (treatment difference: 3.8%, 95% confidence interval: -2.4, 10.0).
No additional viral drug resistance to doravirine was observed in study participants between Week 48 and Week 96, while two study participants in the EFV/FTC/TDF group developed viral drug resistance to EFV.
At Week 96, the rate of discontinuation of therapy due to adverse events was 3.0 percent (11/364) in the DELSTRIGO group and 7.0 percent (27/364) in the EFV/FTC/TDF group. In addition, the three pre-specified neuropsychiatric endpoints of dizziness, sleep disorders/disturbances and altered sensorium were significantly less frequent in the DELSTRIGO group than in the EFV/FTC/TDF group: dizziness (10.2% vs. 38.2%, treatment difference: -28%, 95% confidence interval: -33.9, -22.1), sleep disorders and disturbances (14.0% vs. 27.5%, treatment difference: -13.5%, 95% confidence interval: -19.3, -7.6) and altered sensorium (4.9% vs. 8.5%, treatment difference: -3.6%, 95% confidence interval: -7.4, 0.1).
The study also reported lower mean changes from baseline in the levels of fasting lipids in the DELSTRIGO group compared with the EFV/FTC/TDF group at Week 96, including LDL-C (-0.6 mg/dL vs. 10.8 mg/dL, treatment difference: -11.1, 95% confidence interval: -14.8, -7.4) and non-HDL-C (-2.1 mg/dL vs. 15.0 mg/dL, treatment difference: -17.0, 95% confidence interval: -21.1, -13.0).
“At Merck, we are committed to continued scientific innovation as we look for new ways to help improve how HIV is treated. The recent U.S. Food and Drug Administration approval of DELSTRIGO represents this ongoing commitment,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories. “We are pleased to see the efficacy results for DELSTRIGO at 96 weeks, which support the initial findings seen in the 48 week data.”
On Aug. 30, 2018, DELSTRIGO and PIFELTRO (doravirine) were approved by the U.S. Food and Drug Administration (FDA). DELSTRIGO was approved as a once-daily fixed-dose combination tablet of doravirine (100 mg), 3TC (300 mg) and TDF (300 mg); and PIFELTRO (100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), was approved to be administered in combination with other antiretroviral medicines. Both DELSTRIGO and PIFELTRO are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. In the U.S., DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection. DELSTRIGO (doravirine/3TC/TDF) does not cure HIV-1 infection or AIDS. On Sept. 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending granting of marketing authorization for DELSTRIGO (doravirine/3TC/TDF) and PIFELTRO (doravirine).
About DRIVE-AHEAD
DRIVE-AHEAD is a Phase 3 multicenter, double-blind, randomized clinical trial in which 728 participants with no antiretroviral treatment history were randomized and received at least one dose of either DELSTRIGO or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg) once daily. The primary endpoint of the clinical trial was the proportion of participants with HIV-1 RNA copies of less than 50 copies/mL at Week 48. The primary safety endpoint was the proportion of participants with neuropsychiatric adverse events through Week 48 in the following pre-specified categories: dizziness, sleep disorders and disturbances and the inability to think clearly or concentrate (altered sensorium). The trial consists of a 96-week double-blind treatment period (base study) and an open label extension after participants complete the base study. Secondary endpoints include efficacy at Week 96, an evaluation of the effects of DELSTRIGO and EFV/FTC/TDF on fasting serum lipids, change from baseline in CD4+ T-cell count and evaluation of safety and tolerability. For further information regarding DRIVE-AHEAD please visit www.clinicaltrials.gov clinical trial registry number NCT02403674.
Our Commitment to HIV
For more than 30 years, Merck has been committed to scientific research and discovery in HIV and we continue to be driven by the conviction that more medical advances are still to come. Our focus is on pursuing research that addresses unmet medical needs and helps people living with HIV and their communities. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges to continuing progress.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 30
KENILWORTH, NJ, USA I October 04, 2018 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new results from the Phase 3 DRIVE-AHEAD clinical trial evaluating the efficacy and safety of DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in treatment-naïve adults with HIV-1 infection. The efficacy findings at Week 96 in DRIVE-AHEAD were consistent with the findings at Week 48 in which DELSTRIGO demonstrated non-inferior efficacy in comparison to a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg). The pivotal Phase 3, Week 48 data were previously presented at the 9th IAS Conference on HIV Science / IAS 2017.
The new Week 96 findings will be presented today as a late-breaking oral presentation at IDWeek 2018 taking place Oct. 3-7, 2018, in San Francisco.
“Long-term data from this pivotal clinical trial further confirm the efficacy and safety of DELSTRIGO in treatment-naïve patients,” said Dr. Jean-Michel Molina, Professor of Infectious Diseases, University of Paris, and Head of the Infectious Diseases Department at Saint-Louis Hospital in Paris, France. “The data position this fixed-dose combination as a new treatment option that can address the needs of people living with HIV today.”
Data from DRIVE-AHEAD
In DRIVE-AHEAD, 728 participants with no antiretroviral treatment history were randomized and received at least one dose of either DELSTRIGO or EFV/FTC/TDF once daily. In this trial, after 96 weeks of treatment, the proportion of participants achieving plasma HIV-1 RNA levels less than 50 copies/mL was 77.5 percent in the group treated with DELSTRIGO (doravirine/3TC/TDF) and 73.6 percent in the group treated with EFV/FTC/TDF (treatment difference: 3.8%, 95% confidence interval: -2.4, 10.0).
No additional viral drug resistance to doravirine was observed in study participants between Week 48 and Week 96, while two study participants in the EFV/FTC/TDF group developed viral drug resistance to EFV.
At Week 96, the rate of discontinuation of therapy due to adverse events was 3.0 percent (11/364) in the DELSTRIGO group and 7.0 percent (27/364) in the EFV/FTC/TDF group. In addition, the three pre-specified neuropsychiatric endpoints of dizziness, sleep disorders/disturbances and altered sensorium were significantly less frequent in the DELSTRIGO group than in the EFV/FTC/TDF group: dizziness (10.2% vs. 38.2%, treatment difference: -28%, 95% confidence interval: -33.9, -22.1), sleep disorders and disturbances (14.0% vs. 27.5%, treatment difference: -13.5%, 95% confidence interval: -19.3, -7.6) and altered sensorium (4.9% vs. 8.5%, treatment difference: -3.6%, 95% confidence interval: -7.4, 0.1).
The study also reported lower mean changes from baseline in the levels of fasting lipids in the DELSTRIGO group compared with the EFV/FTC/TDF group at Week 96, including LDL-C (-0.6 mg/dL vs. 10.8 mg/dL, treatment difference: -11.1, 95% confidence interval: -14.8, -7.4) and non-HDL-C (-2.1 mg/dL vs. 15.0 mg/dL, treatment difference: -17.0, 95% confidence interval: -21.1, -13.0).
“At Merck, we are committed to continued scientific innovation as we look for new ways to help improve how HIV is treated. The recent U.S. Food and Drug Administration approval of DELSTRIGO represents this ongoing commitment,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories. “We are pleased to see the efficacy results for DELSTRIGO at 96 weeks, which support the initial findings seen in the 48 week data.”
On Aug. 30, 2018, DELSTRIGO and PIFELTRO (doravirine) were approved by the U.S. Food and Drug Administration (FDA). DELSTRIGO was approved as a once-daily fixed-dose combination tablet of doravirine (100 mg), 3TC (300 mg) and TDF (300 mg); and PIFELTRO (100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), was approved to be administered in combination with other antiretroviral medicines. Both DELSTRIGO and PIFELTRO are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. In the U.S., DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection. DELSTRIGO (doravirine/3TC/TDF) does not cure HIV-1 infection or AIDS. On Sept. 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending granting of marketing authorization for DELSTRIGO (doravirine/3TC/TDF) and PIFELTRO (doravirine).
About DRIVE-AHEAD
DRIVE-AHEAD is a Phase 3 multicenter, double-blind, randomized clinical trial in which 728 participants with no antiretroviral treatment history were randomized and received at least one dose of either DELSTRIGO or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg) once daily. The primary endpoint of the clinical trial was the proportion of participants with HIV-1 RNA copies of less than 50 copies/mL at Week 48. The primary safety endpoint was the proportion of participants with neuropsychiatric adverse events through Week 48 in the following pre-specified categories: dizziness, sleep disorders and disturbances and the inability to think clearly or concentrate (altered sensorium). The trial consists of a 96-week double-blind treatment period (base study) and an open label extension after participants complete the base study. Secondary endpoints include efficacy at Week 96, an evaluation of the effects of DELSTRIGO and EFV/FTC/TDF on fasting serum lipids, change from baseline in CD4+ T-cell count and evaluation of safety and tolerability. For further information regarding DRIVE-AHEAD please visit www.clinicaltrials.gov clinical trial registry number NCT02403674.
Our Commitment to HIV
For more than 30 years, Merck has been committed to scientific research and discovery in HIV and we continue to be driven by the conviction that more medical advances are still to come. Our focus is on pursuing research that addresses unmet medical needs and helps people living with HIV and their communities. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges to continuing progress.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 30
