Data Presented at CROI Showed Doravirine Was
Non-inferior to Ritonavir-boosted Darunavir in Treatment-naïve
Adults after 48 weeks of Treatment
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced results of a pivotal Phase 3 clinical trial
evaluating the safety and efficacy of doravirine (MK-1439), an
investigational non-nucleoside reverse transcriptase inhibitor
(NNRTI). The study met its primary efficacy endpoint of the
proportion of participants achieving levels of HIV-1RNA less than
50 copies/mL after 48 weeks of treatment, demonstrating the
non-inferiority of once-daily doravirine (DOR) to once-daily
ritonavir-boosted darunavir (DRV+r), each administered with
tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or
abacavir/lamivudine (ABC/3TC), in previously untreated
(treatment-naïve) adults with HIV-1 infection. In addition, a
secondary endpoint showed that the DOR-treated group had
statistically significant lower levels of fasting low density
lipoprotein cholesterol (LDL-C), versus the DRV+r group. Findings
from the ongoing “DRIVE-FORWARD” Phase 3 trial following 48 weeks
of treatment were presented as a late-breaking abstract at the
annual Conference on Retroviruses and Opportunistic Infections
(CROI) being held in Seattle from Feb. 13-16, 2017.
“Improved understanding of the biology of HIV and growing
clinical evidence from current therapies are advancing the
management of HIV infection,” said Dr. Kathleen Squires, professor
and director of infectious diseases, Thomas Jefferson University,
Philadelphia. “The results of this study provide solid evidence of
the efficacy and safety profile of doravirine as a potential
treatment option for treatment-naïve HIV-1 patients.”
Data from DRIVE- FORWARD
In the trial, after 48 weeks of treatment, the proportion of
participants achieving levels of HIV-1 RNA less than 50 copies/mL
following once-daily DOR (100 mg) or once-daily DRV+r (800 mg and
100 mg respectively), each in combination with either TDF/FTC or
ABC/3TC, was 83.8 percent (321/383) and 79.9 percent (306/383),
respectively; with a treatment difference (95 % confidence
interval) of 3.9 [-1.6, 9.4]. Increases in mean CD4+ T-cell counts
from baseline were similar for the DOR and DRV+r treatment groups:
193 and 186 cells/mm3, respectively.
In addition, comparable efficacy was observed for participants
with baseline levels of HIV-1 RNA greater than 100,000 copies/mL:
81.0 percent (64/79) for DOR and 76.4 percent (55/72) for DRV+r;
with a treatment difference (95% confidence interval) of 3.0
[-11.2, 17.1]. One out of 383 participants developed phenotypic and
genotypic resistance in the DOR arm (the patient came off study at
Week 24 because of non-adherence). None of the 383 participants
receiving DRV+r developed phenotypic and genotypic resistance.
The rates of reported adverse drug reactions were 31 percent
(117/383) for DOR and 32 percent (123/383) for DRV+r.
Discontinuations due to adverse events for the DOR and DRV+r
treatment groups were 2 percent (6/383) and 3 percent (12/383),
respectively. The most common adverse events for DOR and DRV+r
(occurring in greater than or equal to 10 percent of participants)
were: diarrhea (14% vs. 22%); headache (14% vs. 11%); nausea (11%
vs. 12%) and nasopharyngitis (8% vs. 10 %), respectively.
Analysis of fasting serum blood lipids for the DOR and DRV+r
treated groups showed a statistically significant difference
(p<0.0001) in mean changes from baseline in the levels of LDL-C
(-4.5 mg/dL vs. +9.9 mg/dL) and non-high density lipoprotein
cholesterol (non-HDL-C) (-5.3 mg/dL vs. +13.8 mg/dL), respectively.
Mean changes from baseline in total cholesterol, high density
lipoprotein cholesterol (HDL-C) and triglycerides for the DOR-
treated group and the DRV+r- treated group were -1.4 mg/dL, +3.9
mg/dL, and -3.1 mg/dL vs. +17.9 mg/dL, +4.2 mg/dL, and +22 mg/dL,
respectively.
“Merck has been at the forefront of research into HIV for three
decades,” said Dr. George Hanna, associate vice president, clinical
research, Merck Research Laboratories. “We are encouraged by these
results, which provide additional insights into the efficacy and
safety of doravirine.”
About DRIVE-FORWARD
DRIVE-FORWARD is a multicenter, double-blind, randomized
non-inferiority trial in which 769 treatment-naïve adults with
HIV-1 infection received either 100 mg doravirine or 800 mg
darunavir plus 100 mg ritonavir, both administered orally
once-daily in combination with either TDF/FTC or ABC/3TC. 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. There were a number of secondary endpoints, including an
evaluation of the effects of DOR and DRV+r on fasting serum lipids,
change from baseline in CD4+ T-cell count, and evaluation of safety
and tolerability.
For further information regarding DRIVE-FORWARD please visit
www.clinicaltrials.gov clinical trial registry number
NCT02275780.
About Doravirine
Doravirine is an investigational NNRTI being evaluated by Merck
for the treatment of HIV-1 infection. In early clinical studies,
doravirine demonstrated a pharmacokinetic profile supportive of
once-daily dosing and the ability to be dosed with or without
food.
Doravirine is also being evaluated in several ongoing studies as
a fixed dose single tablet regimen with 3TC and TDF (DOR/3TC/TDF).
Phase 2 studies include an evaluation of DOR/3TC/TDF in
treatment-naïve participants with transmitted resistance to NNRTIs
and in people switching from efavirenz due to intolerability. Phase
3 studies include DRIVE-AHEAD, a trial comparing DOR/3TC/TDF to
efavirenz/ FTC/TDF in treatment-naïve participants, and
DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in people
who are currently virologically suppressed on another
antiretroviral regimen.
About Merck
For over a century, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. 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. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
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