Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study

Orkin, Chloe; Oka, Shinichi; Philibert, Patrick; Brinson, Cynthia; Bassa, Ayesha; Гусев, Д. А.; Degen, Olaf; García, Juan González; Morell, Enrique Bernal; Tan, Darrell H. S.; D’Amico, Ronald; Dorey, David; Griffith, Sandy; Thiagarajah, Shanker; Clair, Marty St.; Solingen‐Ristea, Rodica Van; Crauwels, Herta; Ford, Susan L.; Patel, Parul; Chounta, Vasiliki; Vanveggel, Simon; Cutrell, Amy; Eygen, Veerle Van; Vandermeulen, Kati; Margolis, David; Smith, Kimberly Y.; Spreen, William

doi:10.1016/s2352-3018(20)30340-4

Cited by 88 publications

(76 citation statements)

References 23 publications

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“…Further, most participants transitioning from ATLAS switched from the Q4W regimen and had therefore accumulated ≥ 96 weeks of CAB + RPV LA exposure by Week 48 of ATLAS-2M (65%, n = 253/391). These longer-term findings are consistent with the high participant satisfaction reported at Week 96 in FLAIR, and when taken together suggest that the benefits of longacting therapy can be sustained over ~ 2 years [38]. Over time, minor fluctuations are to be expected in treatment satisfaction and acceptance scores, both of which remained at high levels throughout the study.…”

Section: Discussionsupporting

confidence: 80%

Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)

Chounta

Overton

Mills

et al. 2021

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Background Advances in HIV-1 therapeutics have led to the development of a range of daily oral treatment regimens, which share similar high efficacy rates. Consequently, more emphasis is being placed upon the individual's experience of treatment and impact on quality of life. The first long-acting injectable antiretroviral therapy for HIV-1 (long-acting cabotegravir + rilpivirine [CAB + RPV LA]) may address challenges associated with oral treatment for HIV-1, such as stigma, pill burden/fatigue, drug-food interactions, and adherence. Patient-reported outcomes (PROs) collected in an HIV-1 clinical trial (ATLAS-2M; NCT03299049) comparing participants' experience with two dosing regimens (every 4 weeks [Q4W] vs. every 8 weeks [Q8W]) of CAB + RPV LA are presented herein. Methods PRO endpoints evaluated through 48 weeks of therapy included treatment satisfaction (HIV Treatment Satisfaction Questionnaire [HIVTSQ]), treatment acceptance ("General Acceptance" domain of the Chronic Treatment Acceptance [ACCEPT ® ] questionnaire), acceptability of injections (Perception of Injection [PIN] questionnaire), treatment preference (questionnaire), and reasons for switching to/continuing long-acting therapy (exploratory endpoint; questionnaire). Participants were randomized 1:1 to receive CAB + RPV LA Q8W or Q4W. Results were stratified by prior CAB + RPV exposure in either preplanned or post hoc analyses. Results Overall, 1045 participants were randomized to the Q8W (n = 522) and Q4W (n = 523) regimens; 37% (n = 391/1045) had previously received CAB + RPV in ATLAS. For participants without prior CAB + RPV exposure, large increases from baseline were reported in treatment satisfaction in both long-acting arms (HIVTSQ status version), with Q8W dosing statistically significantly favored at Weeks 24 (p = 0.036) and 48 (p = 0.004). Additionally, improvements from baseline were also observed in the "General Acceptance" domain of the ACCEPT questionnaire in both long-acting arms for participants without prior CAB + RPV exposure; however, no statistically significant difference was observed between arms at either timepoint (Week 24, p = 0.379; Week 48, p = 0.525). Significant improvements (p < 0.001) in the "Acceptance of Injection Site Reactions" domain of the PIN questionnaire were observed from Week 8 to Weeks 24 and 48 in both arms for participants without prior CAB + RPV exposure. Participants with prior CAB + RPV exposure reported high treatment satisfaction (mean [HIVTSQ status version]: Q8W 62.2/66.0; Q4W 62.0/66.0), treatment acceptance (mean: Q8W 89.3/100; Q4W 91.2/100), and acceptance of injection site reactions (mean [5 = not at all acceptable; 1 = totally acceptable]: Q8W 1.72; Q4W 1.59) at baseline/Week 8 that were maintained over time. Participants without prior CAB + RPV exposure who received Q8W dosing preferred this regimen over oral CAB + RPV (98%, n = 300/306). Among those with prior Q4W exposure, 94% (n = 179/191) preferred Q8W dosing versus Q4W dosing (3%, n = 6/191) or oral CAB + RPV (2%, n = 4/191). Conclusions B...

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Section: Discussionsupporting

confidence: 80%

Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)

Chounta

Overton

Mills

et al. 2021

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“…In March 2020, the world's rst long-acting intramuscular formulation of cabotegravir (CAB) and rilpivirine (RPV) was approved in Canada, making the use of parenteral drugs possible. These drugs had su cient blood levels with good antiretroviral e cacy when administered once every 1 to 2 months [10][11][12]. However, the intramuscular formulation in Canada is approved only for maintenance therapy in patients who have been successfully treated.…”

Section: Discussionmentioning

confidence: 99%

Protein-losing Enteropathy Caused by Disseminated Mycobacterium Avium Complex Infection in a Patient Receiving Antiretroviral Therapy: An Autopsy Case Report

Konishi

Nakagawa

Nakahira

et al. 2021

Preprint

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Background: Disseminated Mycobacterium avium complex infection is an important indicator of acquired immunodeficiency syndrome (AIDS) in patients with advanced human immunodeficiency virus (HIV) infection. Effective antiretroviral therapy has dramatically reduced the incidence and mortality of HIV, although drug resistance and poor medication adherence continue to increase the risk of disseminated M. avium complex infection. However, gastrointestinal lesions in cases of disseminated M. avium complex infection resulting in protein-losing enteropathy have been rarely discussed. Therefore, we report a case of protein-losing enteropathy caused by disseminated M. avium complex infection in a patient undergoing antiretroviral therapy.Case presentation: A 29-year-old male diagnosed with AIDS for four years and was admitted for a 10-month history of refractory diarrhea and fever. Despite receiving antiretroviral therapy, viral load remained elevated due to poor medication adherence. The patient was diagnosed with disseminated M. avium complex infection and started on antimycobacterial drugs two years prior to admission. However, it remained uncontrolled. Previous hospitalization a year before admission was due to hypoalbuminemia and refractory diarrhea. Upper gastrointestinal endoscopy revealed a diagnosis of protein-losing enteropathy caused by intestinal lymphangiectasia, and treatment with intravenous antimycobacterial drugs did not resolve his intestinal lymphangiectasia. The patient inevitably died of sepsis.Conclusions: Clinical remission is difficult to achieve in patients with AIDS and protein-losing enteropathy caused by disseminated M. avium complex infection due to its limited options for parenteral antiretroviral drugs.

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“…Many of the potential challenges in terms of real-life adherence, managing late/missed doses and real-life discontinuation rates are yet to be experienced by most of clinicians. The data supporting the efficacy, safety, and tolerability of IM CAB/RPV is provided by the ATLAS 14 and FLAIR studies, 15 along with impressive patient-reported outcomes indicating a strong preference for injectable over oral ARVs. Of note, the approval in Canada and the USA for IM CAB/RPV involves monthly dosing, whereas the European Medicines Agency has approved both monthly and 2-monthly dosing, based on the published 48-week results of the ATLAS-2M study.…”

Section: New Antiretroviral Drugsmentioning

confidence: 99%

Highlights from the virtual conference on retroviruses and opportunistic infections (CROI) 2021: SARS-CoV-2 pathogenesis, new data about antiretroviral treatments, HIV-associated comorbidities, pediatrics and pregnancy

Psomas¹,

Waters

Barber

2021

Journal of Virus Eradication

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Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study

Cited by 88 publications

References 23 publications

Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)

Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)

Protein-losing Enteropathy Caused by Disseminated Mycobacterium Avium Complex Infection in a Patient Receiving Antiretroviral Therapy: An Autopsy Case Report

Highlights from the virtual conference on retroviruses and opportunistic infections (CROI) 2021: SARS-CoV-2 pathogenesis, new data about antiretroviral treatments, HIV-associated comorbidities, pediatrics and pregnancy

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