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High Satisfaction With Injected Long-Acting CAB + RPV in LATTE-2 Trial
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21st International AIDS Conference (AIDS 2016), July 18-22, 2016, Durban, South Africa
IAC: Experiences with long acting injectable ART: a qualitative study among PLHIV participating in a Phase II study of Cabotegravir + Rilpivirine (LATTE-2) in the United States and Spain - (07/25/14)
Mark Mascolini
Almost all participants receiving injected long-acting cabotegravir plus rilpivirine (CAB + RPV) every 4 weeks or every 8 weeks in the LATTE-2 trial said they would continue getting the shots, despite initial complaints of injection-site reactions [1]. The highest dissatisfaction scores involved discomfort/pain, flexibility, and side effects, but only about 5% of participants registered dissatisfaction for each of those issues.
Long-acting CAB + RPV is about to enter phase 3 trials at once-monthly dosing for maintenance of viral control in people treated with oral CAB plus abacavir/lamivudine (ABC/3TC) or with other regimens [2]. In the phase 2 LATTE-2 trial, antiretroviral-naive people took oral CAB plus ABC/3TC for 20 weeks. Those with a viral load below 50 copies after 20 weeks switched to injected CAB + RPV every 4 weeks or every 8 weeks, or they continued their oral regimen. At week 48 of the randomized phase, 94% and 95% who switched from oral therapy to long-acting CAB + RPV every 4 or 8 weeks maintained a viral load below 50 copies, as did 91% in the continued oral arm [3].
The satisfaction analysis focused on 286 LATTE-2 participants who switched to injected CAB + RPV every 4 or 8 weeks or kept taking oral CAB plus ABC/3TC. About 90% of participants were men and about 20% nonwhite. Among the 230 people receiving injected CAB + RPV for 32 weeks, 2 dropped out because of injection intolerability. Overall, 92% of participants getting injections complained of injection-site pain, but 82% of injection-site reactions were mild and 17% moderate. Reactions lasted a median of 3 days in both the every-4-week and every-8-week groups. Proportions of participants reporting injection-site reactions dropped from 86% on day 1 to 33% at week 32.
Proportions of participants who rated their pain or discomfort as "none at all" proved similar with CAB shots and RPV shots and in both the every-4-week group and the every-8-week group. At week 8 about 27% in both groups reported no pain at all; by week 32 those proportions had climbed to about 35%.
At week 32 of the injection phase of LATTE-2, 96% getting shots every 4 weeks and 97% getting shots every 8 weeks expressed satisfaction with their current treatment, compared with 71% in the continued-oral therapy arm. Similarly, 98% getting shots every 4 weeks and 98% getting shots every 8 weeks expressed willingness to continue getting shots, compared with 71% in the oral-maintenance arm who said they would continue that treatment.
If long-acting CAB + RPV gets licensed for maintenance therapy, the regimen would be a first step in transforming long-term treatment of HIV infection. But getting treated with a monthly shot instead of a daily pill does not guarantee better adherence for all. Some people will find it easier to remember a daily pill than a monthly shot. And the consequences of missing scheduled shots are not negligible. Another study presented at the International AIDS Conference found that long-acting RPV remains detectable in female genital tract fluids up to 18 months after a single injection [4]. A person who misses a RPV shot could wind up with persistent low levels of the drug that allow emergence of resistant virus. Because LATTE-2 enrolled mostly white men, it will be interesting to see if these high satisfaction scores hold true in women and other racial/ethnic groups.
References
1. Murray M, Dorey D, Griffith S, Mrus J, Spreen W, Margolis D. Satisfaction, tolerability, and acceptability of cabotegravir (CAB) + rilpivirine (RPV) long-acting therapy: LATTE-2 results. 21st International AIDS Conference (AIDS 2016). July 18-22, 2016. Durban, South Africa. Abstract THPEB052. http://programme.aids2016.org/PAGMaterial/eposters/0_5385.pdf
2. Spreen W. Cabotegravir long-acting (LA) injectable nanosuspension. 17th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy, June 8-10, 2016, Washington DC. Invited lecture. http://www.natap.org/2016/Pharm/Pharm_39.htm
3. Margolis D, Podzamczer D, Stellbrink HJ, et al. Cabotegravir + rilpivirine as long-acting maintenance therapy: LATTE-2 week 48 results. 21st International AIDS Conference (AIDS 2016). July 18-22, 2016. Durban, South Africa. Abstract THAB0206LB.
4. McGowan I, Siegel A, Engstrom J, et al. Persistence of rilpivirine following single dose of long-acting injection. 21st International AIDS Conference (AIDS 2016). July 18-22, 2016. Durban, South Africa. Abstract TUAC0103.
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