Dolutegravir/Lamivudine for HIV Non-Inferior to 3-Drug Regimen

ViiV Healthcare’s 2-drug HIV regimen of dolutegravir (Tivicay, 50 mg) plus lamivudine (Epivir, 300 mg) demonstrated non-inferiority compared with a regimen containing tenofovir alafenamide fumarate (TAF), according to data from a phase 3 study.
The phase 3 TANGO trial assessed the antiviral efficacy and safety of switching to the 2-drug combination in adults with HIV who are virally suppressed and stable on a TAF-containing regimen.
For the study, eligible participants had been on a TAF-containing regimen with HIV-1 RNA <50 copies per milliliter (c/mL) for at least 6 months, without prior virologic failure, no historical nucleoside reverse transcriptase or integrase inhibitor major resistance mutation, and no evidence of hepatitis B infection. Participants were randomized to switch to dolutegravir plus lamivudine or continue on the TAF-containing regimen through week 148.
Overall, top-line results demonstrated that the study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 c/mL at week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. Additionally, safety results for the 2-drug regimen were consistent with the product labeling for each medicine.
“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression,” Kimberly Smith, MD, head of global research and medical strategy at ViiV Healthcare, said in a statement. “These week 48 data clearly indicate that they can—individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.”
Currently, the single-pill, 2-drug regimen of dolutegravir plus lamivudine is approved in the United States for the treatment of HIV in adults with no antiretroviral treatment history and with no known resistance to either medicines.
The full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science.
ViiV Healthcare announces phase 3 study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen [news release]. GlaxoSmithKline. Accessed July 17, 2019.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

Doug Long, vice president of Industry Relations at IQVIA, discusses rebate reform surrounding Medicare Part D and Part B in an interview with Specialty Pharmacy Times.
An analysis of a quality improvement project at an oncology specialty pharmacy showed that pharmacist interventions can reduce financial toxicity for patients.
Doug Long, MBA, vice president of industry relations at IQVIA, discusses how vertical integration will affect health care delivery.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.