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- Consistent with the SOLAR trial, most people living with HIV who experienced confirmed virologic failure (CVF) with VOCABRIA + REKAMBYS achieved virologic re-suppression‡ (79% [n=15/19], a similar proportion when compared to those who re-suppressed following CVF with daily oral therapy (72% [n=31/43])§1,2
- Following CVF with VOCABRIA + REKAMBYS (n=25), 40% remained on VOCABRIA + REKAMBYS, 40% went to INSTI oral therapy, 16% went to multi-core agents, and one person living with HIV remained off therapy1
INTRODUCING OPERA
A real-world cohort study that compared VOCABRIA + REKAMBYS to daily oral therapy across 23 US states1
This 2-year, non-interventional, real-world US cohort study assessed virologic effectiveness in treatment-experienced, virologically suppressed people living with HIV, who switched from daily oral therapy to VOCABRIA + REKAMBYS, or a different oral ART.1
- Prospectively captured, routine clinical data from electronic health records of 101 clinics in the US (23 US states/territories) representing ~ 14% of people living with HIV in the US1
- Participants' viral loads were monitored from first injection until discontinuation of VOCABRIA + REKAMBYS, death, 12 months since last clinical contact or study end (30 June 2023)1
The OPERA study is based on data previously collected for other purposes, e.g. routine healthcare encounters. As such, there is no requirement for the collection and reporting of Individual Case Safety Reports (ICSRs).
*n baseline characteristics data missing; 133 (Black race), 132 (Hispanic ethnicity), 35 (CD4 cell count).1
Proven efficacy from clinical trials, now shown in a real-world setting1,2
OPERA showed comparable high virologic suppression between VOCABRIA + REKAMBYS and daily oral therapy*1
* Participants switched treatment to VOCABRIA + REKAMBYS or a different oral ART regimen between 21 January 2021 and 31 December 2022. Participants' viral loads were monitored from first injection until treatment discontinuation, death, 12 months since last clinical contact or study end (30 June 2023).1
†Participants with ≥1 follow-up viral load measurement.1
OPERA demonstrated a comparable risk of CVF between VOCABRIA + REKAMBYS and daily oral therapy1
CVF was defined as two viral load measurements of HIV-1 RNA ≥200 copies/mL or one viral load measurement of HIV- 1 RNA ≥200 copies/mL and discontinuation.1
*Participants with ≥1 follow-up viral load measurement.1
†Logistic regression models were fit to assess the risk of CVF by regimen, adjusted for age (linear and quadratic terms), female sex, Black race, injection drug use, history of AIDS-defining events, CD4 count (linear and quadratic terms), presence of comorbidities and core class in prior regimen. Reported OR is excluding 148 individuals missing race or baseline CD4 cell count.1
‡HIV-1 RNA <50 copies/mL.1
§Of those experiencing CVF, 19 out of 25 people living with HIV receiving VOCABRIA + REKAMBYS and 43 out of 78 people living with HIV receiving daily oral therapy had a subsequent viral load test.1
AIDS=acquired immune deficiency syndrome; ART=antiretroviral therapy; CD4=cluster of differentiation 4; CI=confidence interval; CVF=confirmed virologic failure; HIV=human immunodeficiency virus; HIV-1=human immunodeficiency virus type 1; ICSR=Individual Case Safety Report; INSTI=integrase strand transfer inhibitor; IQR=interquartile range; NNRTI=non-nucleoside reverse transcriptase inhibitor; OR=odds ratio; PI=protease inhibitor; RNA=ribonucleic acid.
References
- Hsu RK, Sension M, Fusco JS, et al. Real-World Effectiveness of Cabotegravir + Rilpivirine vs. Standard of Care Oral Regimens in the US. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3–6, 2024. Denver, Colorado, USA. Poster 623.
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting c abotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10(9):e566-e577. doi:10.1016/S2352-3018(23)00136-4.
- A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long-Acting (LA) Plus(+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (SOLAR). 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT04542070. Accessed August 2024.
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
REKAMBYS (rilpivirine long acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under licence by the ViiV Healthcare group of companies.
All other trademarks are owned by the ViiV Healthcare group, or its licensor.
©2024 GSK group of companies. All rights reserved.
PM-IE-CBR-WCNT-240010 | Date of Preparation: September 2024
