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Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial

Margolis, David A, Brinson, Cynthia C, Smith, Graham H R, de Vente, Jerome, Hagins, Debbie P, Eron, Joseph J, Griffith, Sandy K, Clair, Marty H St, Stevens, Marita C, Williams, Peter E, Ford, Susan L, Stancil, Britt S, Bomar, Melinda M, Hudson, Krischan J, Smith, Kimberly Y, Spreen, William R·2015·The Lancet Infectious Diseases
DOI 10.1016/s1473-3099(15)00152-8
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Abstract

Background In phase 1 trials, the HIV-1 integrase strand transfer inhibitor cabotegravir (GSK1265744) was well tolerated, both alone, and in combination with the non-nucleoside reverse transcriptase inhibitor rilpivirine. We assessed cabotegravir plus rilpivirine, as a two-drug oral antiretroviral regimen, for the maintenance of viral suppression in antiretroviral-naive HIV-1-infected individuals.Methods In the phase 2b Long-Acting antireTroviral Treatment Enabling (LATTE) trial, a multicentre study done in Canada and the USA, antiretroviral-naive HIV-1-infected adults (aged ≥18 years) were randomly allocated in a 1:1:1:1 ratio to oral cabotegravir 10 mg once a day, 30 mg once a day, 60 mg once a day, or oral efavirenz 600 mg once a day with dual nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks of induction. Patients who were virologically suppressed by week 24 received a two-drug maintenance regimen consisting of their randomly allocated cabotegravir dose plus oral rilpivirine 25 mg or continued efavirenz plus NRTIs for an additional 72 weeks. Patients and investigators were masked to doses of cabotegravir received for 96 weeks, but not to the assignment of cabotegravir or efavirenz. The primary endpoint was the proportion of patients with fewer than 50 copies per mL of HIV-1 RNA (US Food and Drug Administration snapshot algorithm) at week 48. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, NCT01641809.Findings Of 243 patients randomly allocated and treated, 156 (86%) of 181 patients in the cabotegravir groups (52 [87%] of 60, 51 [85%] of 60, and 53 [87%] of 61 patients in the 10 mg, 30 mg, and 60 mg groups, respectively) and 46 (74%) of 62 in the efavirenz group had fewer than 50 copies per mL of HIV-1 RNA after induction therapy. After patients in the cabotegravir groups were changed over from dual NRTIs to rilpivirine at week 24, 149 (82%; 95% CI 77-88) patients in the cabotegravir groups (48 [80%; 70-90], 48 [80%; 70-90], and 53 [87%; 78-95] patients in the 10 mg, 30 mg, and 60 mg groups, respectively) versus 44 (71%; 60-82) in the efavirenz group were virologically suppressed at week 48, and 137 (76%; 69-82) receiving cabotegravir (41 [68%; 57-80], 45 [75%; 64-86], and 51 [84%; 74-93] patients in the 10 mg, 30 mg, and 60 mg groups, respectively) versus 39 (63%; 51-75) in the efavirenz group were virologically suppressed at week 96. Treatment-related adverse events were reported by 93 (51%) cabotegravir-treated patients (28 [47%], 32 [53%], and 33 [54%] patients in the 10 mg, 30 mg, and 60 mg groups, respectively) and 42 (68%) efavirenz-treated patients. Six (3%) patients in the cabotegravir groups (one [2%], one [2%], and four [7%] patients in the 10 mg, 30 mg, and 60 mg groups, respectively) withdrew because of treatment-emergent adverse events compared with nine (15%) in the efavirenz group.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 longacting injectable formulations of both drugs as a two-drug regimen for the treatment of HIV-1 infection.Funding ViiV Healthcare and Janssen Research and Development.

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Research works printed but not linked: 3

  1. Elion, 2013, A randomized phase 3 study comparing once-daily elvitegravir with twice-daily raltegravir in treatment-experienced subjects with HIV-1 infection: 96-week results, J Acquir Immune Defic Syndr, 63, 494, 10.1097/QAI.0b013e318298469c · DOI
  2. Eron, 2013, Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials, Lancet Infect Dis, 13, 587, 10.1016/S1473-3099(13)70093-8 · DOI
  3. Dudas, 2015, Resistance mutations observed in a study subject on oral two-drug maintenance therapy with 10 mg cabotegravir + 25 mg rilpivirine, Glob Antivir J, 11

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Authors
Margolis, D. A., Brinson, C. C., Smith, G. H. R., de Vente, J., Hagins, D. P., Eron, J. J., Griffith, S. K., Clair, M. H. S., Stevens, M. C., Williams, P. E., Ford, S. L., Stancil, B. S., Bomar, M. M., Hudson, K. J., Smith, K. Y., & Spreen, W. R.
Affiliations
  • GlaxoSmithKline (United States) (US)
  • Maple Leaf Medical Clinic (CA)
  • University of North Carolina at Chapel Hill (US)
  • Janssen (Belgium) (BE)
Corresponding author
Margolis, David A
ORCID
Venue
The Lancet Infectious Diseases
Publisher
Elsevier BV
Published
2015-10
Volume
15
Issue
10
Pages
1145-1155
ISSN
1473-3099 (ISSN-L)
DOI
10.1016/s1473-3099(15)00152-8
OpenAlex
W1674196795
Cited by
204
References
21
Citations by year
2026: 8 · 2025: 13 · 2024: 12 · 2023: 8 · 2022: 14 · 2021: 22 · 2020: 24 · 2019: 18 · 2018: 27 · 2017: 30 · 2016: 20 · 2015: 8
FWCI
22.09
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Infectious Diseases (publishedVersion)
  • PubMed (publishedVersion)
Funders
Janssen Research and Development
Topics
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
  • Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Keywords
cabotegravir, rilpivirine, HIV-1 infection, long-acting antiretroviral therapy, integrase strand transfer inhibitors, efavirenz, nucleoside reverse transcriptase inhibitors, antiretroviral-naive adults, viral suppression, once-daily dosing, dose-ranging, induction regimens
MeSH terms
Rilpivirine, Adolescent, Adult, Aged, Canada, Double-Blind Method, Female, Humans, Male, Middle Aged, Pyridones, United States, HIV-1, HIV Infections, Treatment Outcome, Reverse Transcriptase Inhibitors, Viral Load, Antiretroviral Therapy, Highly Active, Anti-Retroviral Agents, Diketopiperazines, Young Adult

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