Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Design
Study Design: CAB 10 mg CAB 10 mg + 2 NRTI’s + RPV 25 mg • Background: Phase 2b, (n = 60) (n = 52) randomized, partially blinded study done at multiple centers CAB 30 mg CAB 30 mg in the U.S. and Canada + 2 NRTI’s + RPV 25 mg (n = 60) (n = 51) • Inclusion Criteria (n = 244) - Age ≥18 years - Antiretroviral-naïve CAB 60 mg CAB 60 mg - HIV RNA >1,000 copies/mL + 2 NRTI’s + RPV 25 mg - CD4 count >200 cells/mm3 (n = 61) (n = 53) - CrCl >50 mL/min - No hepatitis B Efavirenz 600 mg Efavirenz 600 mg - No significant transaminitis + 2 NRTI’s + 2 NRTI’s (n = 62) (n = 46)
24-week lead-in phase
Source: Margolis DA, et al. Lancet Infect Dis. 2015;15:1145-55. Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Results
Cabotegravir + 2NRTIs Cabotegravir + Rilpivirine Efavirenz + 2NRTIs Induction* Maintenance* 100
80 86 82 76 74 71 60 63
40
HIV RNA <50 copies/mL (%) <50 copies/mL HIV RNA 20
156/181 46/62 149/181 44/62 137/181 39/62 0 Week 24 Week 48 Week 96
*Cabotegravir data is composite of all cabotegravir doses
Source: Margolis DA, et al. Lancet Infect Dis. 2015;15:1145-55. Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Results
100 Induction* Maintenance
80
60
Cabotegravir 10 mg + Rilpivirine 40 Cabotegravir 30 mg + Rilpivirine HIV RNA <40 copies/mL HIV RNA 20 Cabotegravir 60 mg + Rilpivirine Efavirenz 600 mg + 2NRTIs 0 0 12 24 36 48 60 72 84 96 Treatment Week
*During induction phase cabotegravir administered with investigator chosen 2NRTIs Source: Margolis DA, et al. Lancet Infect Dis. 2015;15:1145-55. Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Conclusions
Interpretation: “Cabotegravir plus dual NRTI therapy had potent antiviral activity during the induction phase. As a two drug maintenance therapy, cabotegravir plus rilpivirine provided antiviral activity similar to efavirenz plus dual NRTIs until the end of week 96. Combined efficacy and safety results lend support to our selection of oral cabotegravir 30 mg once a day for further assessment. LATTE precedes studies of the assessment of long-acting injectable formulations of both drugs as a two-drug regimen for the treatment of HIV-1 infection.”
Source: Margolis DA, et al. Lancet Infect Dis. 2015;15:1145-55. Acknowledgment
The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $1,000,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program.
The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.