FDA Grants Approval to 2 New HIV Treatments

Jennifer Barrett, Associate Editor
Published Online: Thursday, August 30th, 2018
Officials with the FDA today approved Merck’s doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) tablet and doravirine (Pifeltro) for the treatment of HIV-1, the company announced in a prepared statement.
 
Both drugs are indicated for oral, once-daily treatment in adult patients with HIV-1 infection who have had no prior antiretroviral treatment experience.
 
Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). Pfiletro, a new non-nuceloside reverse transcriptase inhibitor, is to be administered in combination with other antiretroviral medications.
 
The approvals are based on phase 3 trials DRIVE-AHEAD and DRIVE-FORWARD, which evaluated the efficacy and safety of the 2 treatments, respectively, in adults with HIV-1 who had no antiretroviral treatment history.
 
In the DRIVE-AHEAD clinical trial, 729 patients were randomized to receive at least 1 dose of either doravirine/3TC/TDF or efavirenz/emtricitabine/TDF (EFV 600 mg/FTC 200 mg/TDF 300 mg) once daily. Patients treated with doravirine/3TC/TDF demonstrated sustained viral suppression through 48 weeks compared with those treated with EFV/FTC/TDF, meeting its primary endpoint.
 
Additionally, of the 21% of patients with a high viral load at baseline, 77% in the group treated with doravirine/3TC/TDF and 72% in the EFV/FTC/TDF group achieved HIV-1 RNA <50 copies/mL at week 48. Patients treated with doravirine/3TC/TDF also showed statistically significant superior lipid profiles at this time, as measured by changes from baseline in LDL-cholesterol and non-HDL-cholesterol. A statistically significant lower number of patients treated with doravirine/3TC/TDF reported neuropsychiatric adverse events such as dizziness, sleep disorders and disturbances, and altered sensorium.
 
In the DRIVE-FORWARD study, 766 patients were randomized and received at least 1 dose of either doravirine once daily or darunavir 800 mg plus ritonavir 100 mg (DRV+r),once daily, each in combination with FTC/TDF or abacavir (ABC)/3TC.
 
According to the results, doravirine-treated patients demonstrated sustained viral suppression through 48 weeks. Of the 20% of patients with a high viral load at baseline, 77% in the doravirine group and 74% in the DRV+r group achieved HIV-1 RNA <50 copies/mL at week 48. Patients treated with doravirine also showed statistically significant lipid profiles at week 48, as well.
 
Adverse effects reported by doravirine-treated patients in the trial included nausea, headache, fatigue, diarrhea, and abdominal pain.
 
Both doravirine/3TC/TDF and doravirine can be co-adminstered with a wide range of non-antiretroviral agents, and doravirine may be co-administered with a wide range of antiretroviral agents, according to Merck. Doravirine/3TC/TDF contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B virus infection.
 
Doravirine/3TC/TDF and doravirine are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers, as it may result in decreased effectiveness.
 
Merck anticipates that both drugs will be stocked through wholesalers within 1 month, according to the press release.
 
 
Reference
 
FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients [news release]. Merck’s website. https://www.mrknewsroom.com/news-release/research-and-development-news/fda-approves-mercks-delstrigo-doravirine-lamivudine-tenof. Accessed August 30, 2018.
 


Current Issue

The Educated Patient

Kristen Marjama, DNP, FNP-BC
Gluten proteins found in barley, rye, and wheat trigger systemic injury primarily to the small intestine, but they can also affect the joints, liver, skin, uterus, and other organs.
Kristen Marjama, DNP, FNP-BC
It is that time of year again, when health care providers see an increase in patient volume because no one has time to be sick.
Sara Marlow, MSN, RN, PHN, FNP-C
Sunburn is still a major health issue that can be prevented.
Kristen Marjama, DNP, FNP-BC
The National Health Interview Survey in 2014 estimated that 17.7 million adults and 6.3 million children had asthma.
$vacMongoViewPlus$ $vAR$
Contemporary Clinic
MJH Associates
American Journal of Managed Care
Cure
MD Magazine
ONCLive
OTCGuide
Pharmacy Times
Specialty Pharmacy Times
Targeted Oncology
About Us
Advertise
Careers
Contact Us
Feedback
Privacy
Terms & Conditions
Pharmacy Healthcare & Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-257-0701

Copyright Contemporary Clinic 2018
Pharmacy Healthcare & Communications, LLC. All Rights Reserved.