Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy

Anthony Mills, Gary J Richmond, Cheryl Newman, Olayemi Osiyemi, Jerry Cade, Cynthia Brinson, Jerome De Vente, David A Margolis, Kenneth C Sutton, Viviana Wilches, Sarah Hatch, Jeremy Roberts, Cynthia McCoig, Cindy Garris, Kati Vandermeulen, William R Spreen, Anthony Mills, Gary J Richmond, Cheryl Newman, Olayemi Osiyemi, Jerry Cade, Cynthia Brinson, Jerome De Vente, David A Margolis, Kenneth C Sutton, Viviana Wilches, Sarah Hatch, Jeremy Roberts, Cynthia McCoig, Cindy Garris, Kati Vandermeulen, William R Spreen

Abstract

Objectives: Long-acting formulations of cabotegravir (CAB) and rilpivirine (RPV) have demonstrated efficacy in Phase 3 studies. POLAR (NCT03639311) assessed antiviral activity and safety of CAB+RPV long-acting administered every 2 months (Q2M) in adults living with HIV-1 who previously received daily oral CAB+RPV in LATTE (NCT01641809).

Design: A Phase 2b, multicenter, open-label, rollover study.

Methods: LATTE participants with plasma HIV-1 RNA less than 50 copies/ml who completed at least 300 weeks on study were eligible. Participants elected to switch to either CAB+RPV long-acting Q2M or daily oral dolutegravir/RPV for maintenance of virologic suppression. The primary endpoint was the proportion of participants with HIV-1 RNA greater than or equal to 50 copies/ml at Month 12 (M12) per the Food and Drug Administration Snapshot algorithm. The incidence of confirmed virologic failure (CVF, two consecutive HIV-1 RNA measurements greater than or equal to 200 copies/ml), as well as safety, laboratory, and patient-reported outcomes (HIV Treatment Satisfaction and preference questionnaires) were also assessed.

Results: Of 97 participants enrolled, 90 chose to receive CAB+RPV long-acting and seven chose dolutegravir/RPV. At M12, no participant had HIV-1 RNA greater than or equal to 50 copies/ml or met the CVF criterion in either treatment group. No new safety signals were identified. Total treatment satisfaction was high at Baseline and remained stable through M12 across both treatment groups. Overall, 88% (n = 77/88) of long-acting arm participants preferred CAB+RPV long-acting to oral CAB+RPV.

Conclusion: CAB+RPV long-acting maintained virologic suppression in participants who had previously received daily oral CAB+RPV for at least 5 years in LATTE, with a favorable safety profile. Most participants preferred CAB+RPV long-acting to their prior oral CAB+RPV regimen at M12.

Conflict of interest statement

A.M. has received research funding and consulting fees from ViiV Healthcare, Gilead, Janssen Pharmaceuticals, and Merck, and consulting fees from Shionogi & Co., Ltd. G.J.R. reports grants from Gilead, ViiV Healthcare, and TaiMed. C.N. reports consulting fees from GlaxoSmithKline and ViiV Healthcare, and research support from GlaxoSmithKline and Gilead. O.O. received consulting fees from Gilead, ViiV Healthcare, and Merck. J.C. reports grants, consulting fees, and speaker fees from Gilead, ViiV Healthcare, and Merck. C.B. has received speaker fees from ViiV Healthcare and Gilead and other from GlaxoSmithKline, Janssen Pharmaceuticals, and Sangamo, outside the submitted work.

J.D.V. has nothing to disclose. D.A.M. was an employee of ViiV Healthcare and stockholder of GlaxoSmithKline. K.C.S., C.M., C.G., and W.R.S. are employees of ViiV Healthcare and stockholders of Glaxo-SmithKline. V.W., S.H., and J.R. are employees and stockholders of GlaxoSmithKline. K.V. is an employee and stockholder of Janssen Pharmaceuticals.

Previous presentation: IDWeek; October 21–25, 2020; Virtual; Oral.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Fig. 1
Fig. 1
Study design, screening, and treatment.
Fig. 2
Fig. 2
Efficacy outcomes at Month 12.
Fig. 3
Fig. 3
Treatment preference at Month 12 for participants receiving CAB+RPV LA Q2M.

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Source: PubMed

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