Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings: Results from the TANDEM Study

Stefan Schneider; Gary Blick; Christina Burke; Douglas Ward; Paul Benson; Franco Felizarta; Dallas Green; Cynthia Donovan; Gavin Harper; Deanna Merrill; Aimee A Metzner; Katie Mycock; Hannah Wallis; Jimena Patarroyo; Andrew P Brogan; Alan Oglesby

doi:10.1007/s40121-024-00961-y

Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings: Results from the TANDEM Study

Infect Dis Ther. 2024 Apr;13(4):891-906. doi: 10.1007/s40121-024-00961-y. Epub 2024 Apr 3.

Authors

Stefan Schneider¹, Gary Blick², Christina Burke³, Douglas Ward⁴, Paul Benson⁵, Franco Felizarta⁶, Dallas Green⁷, Cynthia Donovan⁸, Gavin Harper⁹, Deanna Merrill⁸, Aimee A Metzner⁸, Katie Mycock⁹, Hannah Wallis⁹, Jimena Patarroyo⁸, Andrew P Brogan⁸, Alan Oglesby¹⁰

Affiliations

¹ Long Beach Education and Research Consultants, 1040 Elm Avenue, #303, Long Beach, CA, 90813, USA.
² Health Care Advocates International, 2595 Main Street, 2nd Floor, Stratford, CT, 06615, USA.
³ CAN Community Health, 3251 3rd Avenue N, St Petersburg, FL, 33713, USA.
⁴ Dupont Circle Physicians Group, 1145 19th Street NW, Suite 200, Washington, DC, 20009, USA.
⁵ Be Well Medical Center, 1964 W Eleven Mile Road, Berkley, MI, 48072, USA.
⁶ Bakersfield Family Medical Center, 4580 California Avenue, Bakersfield, CA, 93309, USA.
⁷ AHF Healthcare Center-Kinder, 3661 S Miami Avenue, Suite 806, Miami, FL, 33133, USA.
⁸ ViiV Healthcare, 406 Blackwell Street, Suite 300, Durham, NC, 27701, USA.
⁹ Adelphi Real World, Adelphi Mill, Grimshaw Lane, Bollington, Macclesfield, SK10 5JB, UK.
¹⁰ ViiV Healthcare, 406 Blackwell Street, Suite 300, Durham, NC, 27701, USA. alan.k.oglesby@viivhealthcare.com.

Abstract

Introduction: Dolutegravir/lamivudine (DTG/3TC) and dolutegravir/rilpivirine (DTG/RPV) are fixed-dose, complete, single-tablet, two-drug regimens (2DRs) indicated for HIV-1. DTG/3TC is approved for antiretroviral therapy (ART)-naive people with HIV-1 and virologically suppressed individuals to replace current ART; DTG/RPV is indicated for virologically suppressed individuals as a switch option. Virologic efficacy and effectiveness of these DTG-based 2DRs have been demonstrated in phase 3 clinical trials and real-world cohorts, primarily from Europe. This study characterized real-world use of DTG-based 2DRs for HIV-1 treatment in the USA.

Methods: TANDEM was a retrospective medical chart review across 24 US sites. Individuals aged ≥ 18 years who initiated DTG/3TC or DTG/RPV before September 30, 2020, with ≥ 6 months of follow-up were included. One cohort included ART-naive people who initiated DTG/3TC (n = 126), and two other cohorts included virologically suppressed (HIV-1 RNA < 50 copies/mL) people on stable ART regimens for ≥ 3 months before switch to either DTG/3TC (n = 192) or DTG/RPV (n = 151). Clinical characteristics, treatment history, and outcomes are described.

Results: Virologically suppressed individuals were older than those who were ART-naive, and the ART-naive cohort had higher proportions of individuals assigned male at birth and of Hispanic ethnicity. The most common healthcare provider-reported reason for choosing a DTG-based 2DR was avoidance of long-term toxicities (25-33% across cohorts), followed by simplification/streamlining of treatment. Among ART-naive people on DTG/3TC, 94% achieved virologic suppression after initiation, and 83% maintained suppression at last follow-up; discontinuation rate was < 1%. Among cohorts who switched to DTG-based 2DRs, 96% maintained virologic suppression on DTG/3TC and 93% on DTG/RPV; 2% on DTG/3TC and 3% on DTG/RPV discontinued.

Conclusion: Motivation for selecting DTG-based 2DRs was primarily driven by a desire to avoid or manage toxicities and simplify treatment. Results demonstrate that DTG/3TC and DTG/RPV are effective in real-world settings, with few discontinuations, reflecting data from clinical trials.

Keywords: Dolutegravir; HIV-1 infection; Lamivudine; Real-world evidence; Rilpivirine; Two-drug regimen.