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Case Series of People With HIV on the Long-Acting Combination of Lenacapavir and Cabotegravir: Call for a Trial
 
 
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Open Forum Infectious Diseases, Volume 11, Issue 4, April 2024
Monica Gandhi,1 , Lucas Hill,2 Janet Grochowski,1 Alexander Nelson,3 Catherine A. Koss,1 Francis Mayorga-Munoz,1 Jon Oskarsson,1 Mary Shiels,1
Ann Avery,4 Laura Bamford,2 Jillian Baron,5 , William R. Short,5 and Corrilynn O. Hileman4
 
IDWeek: LAI CAB/RPV plus SC LEN Effective in PWH with Poor Long-term Adherence and INSTI or NNRTI RAMs - (10/23/24)
 
"we call for a trial of LA LEN and LA CAB for those with NNRTI resistance.”
 
"The presentation of this case series serves as a call for a trial of this novel LA ART combination among individuals with adherence barriers to oral ART and NNRTI resistance."
 
'The companies that make LEN and CAB have now expressed interest in a small PADDLE-like study of LEN/CAB initially among participants with NNRTI resistance to be conducted in the AIDS Clinical Trials Group (ACTG), now renamed Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections"
 
Abstract
Background

 
Injectable cabotegravir (CAB)/rilpivirine (RPV) is the only combination long-acting (LA) antiretroviral regimen approved for HIV. RPV may not be effective among individuals with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance, which has >10% prevalence in many countries. Lenacapavir (LEN) is an LA capsid inhibitor given every 6 months, but has not been studied in combination with other LA agents.
 
Methods
 
We assembled a case series from 4 US academic medical centers where patients with adherence challenges were prescribed LEN subcutaneously every 26 weeks/CAB (+/− RPV) intramuscularly every 4 or 8 weeks. Descriptive statistics, including viral load (VL) outcomes, were summarized.
 
Results
 
All patients (n = 34: 76% male; 24% cis/trans female; 41% Black; 38% Latino/a; median age [range], 47 [28–75] years; 29% and 71% on CAB every 4 or 8 weeks) reported challenges adhering to oral ART. The reasons for using LEN/CAB with or without RPV were documented or suspected NNRTI mutations (n = 21, 59%), integrase mutations (n = 5, 15%), high VL (n = 6, 18%), or continued viremia on CAB/RPV alone (n = 4, 12%). Injection site reactions on LA LEN were reported in 44% (32% grade I, 12% grade 2). All patients but 2 (32/34; 94%) were suppressed (VL <75 copies/mL) after starting LEN at a median (range) of 8 (4–16) weeks, with 16/34 (47%) suppressed at baseline.
 
Conclusions
 
In this case series of 34 patients on LEN/CAB, high rates of virologic suppression (94%) were observed. Reasons for using LEN/CAB included adherence challenges and underlying resistance, mostly to NNRTIs. These data support a clinical trial of LEN/CAB among persons with NNRTI resistance.

 
 
 
 
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