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Cabenuva

What We’ve Learned and What We Can Look Forward To

Many barriers exist with CAB/RPV implementation that may be easily managed. For successful implementation, intense collaboration among care team members, external support, and excellent communication are necessary. This article discusses the lessons from LA CAB/RPV injections and strategies to improve access and utilization.

Ton K, Kherghehpoush S. What We’ve Learned and What We Can Look Forward To. HIV Specialist. Published online January 2024:8-11.165. https://aahivm.ygsclicbook.com/pubs/hiv-specialist/2023/winter-2023/live/#p=11
Cabenuva

Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV

Since 2021, the Ward 86 Clinic at the University of California, San Francisco (UCSF) has conducted a pilot study on injected CAB/RPV in patients with viremia. The study enrolled 133 patients who received injected CAB/RPV, 57 of whom had viremia. The mean log10 viral load of these 57 patients was 4.21, and the mean CD4 count was 215 cells/mm3. The pilot study targeted patients with significant barriers to taking oral antiretroviral medication. Therefore, most of the participants with viremia were either unstably housed (42%) or unhoused (10%) and half of them were also using stimulants. Almost all the participants in the pilot study had health insurance (Medicaid, Medicare, or both), as the study was conducted in California. Patients who wanted to participate in the study had to verbally commit to coming to the clinic on time for their injections. The injections were scheduled every four weeks, with graduation to every eight weeks if viral suppression was achieved after three months.

Gandhi M, Hickey M, Imbert E, et al. Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV. Ann Intern Med. 2023;176(7):969-974. doi:10.7326/M23-0788
Cabenuva

Intramuscular cabotegravir and rilpivirine concentrations after switching from efavirenz-containing regimen

Intramuscular cabotegravir/rilpivirine (IM CAB/RPV) are metabolized by UGT1A1/CYP3A4. Efavirenz induces both enzymes; therefore, switching from an efavirenz-containing regimen to IM CAB/RPV could possibly result in suboptimal levels. Due to their long dosing interval, clinical studies with IM CAB/RPV are challenging. We used physiologically based pharmacokinetic (PBPK) modeling to simulate switching from efavirenz to IM CAB/RPV. In conclusion, the simulations indicate that people on efavirenz-, etravirine- or nevirapine-based regimens with inducing properties could be directly switched to IM cabotegravir and rilpivirine without the risk of having a time window with suboptimal drug levels.

Bettonte S, Berton M, Stader F, Battegay M, Marzolini C. Intramuscular cabotegravir and rilpivirine concentrations after switching from efavirenz-containing regimen. British Journal of Clinical Pharmacology. 2023;89(12):3618-3628. doi: ‌
Apretude

Securing accelerated access to long-acting injectable cabotegravir for HIV prevention in low- and middle-income countries

Reductions in HIV acquisition have slowed, and the global community is significantly off track from global goals. Oral pre-exposure prophylaxis (PrEP) alone cannot address the diverse needs of the millions of people at risk of HIV acquisition. Long-acting injectable cabotegravir (CAB-LA) received United States Food and Drug Administration approval for HIV prevention in December 2021. When studied, CAB-LA demonstrated high effectiveness, provides months of protection versus daily use, is preferred by some users and has the potential to reduce commodity costs. These factors position CAB-LA to catalyze transformation in HIV prevention. Significant work must be undertaken to ensure at-scale uptake in low- and middle-income countries.

Jenkins S, Resar D, Panos Z, et al. Securing accelerated access to long‐acting injectable cabotegravir for HIV prevention in low‐ and middle‐income countries. Journal of the International AIDS Society. 2023;26(S2). doi:https://doi.org/10.1002/jia2.26101
Lenacapavir

Lenacapavir with Fostemsavir in a Multidrug-Resistant HIV-Infected Hemodialysis Patient

This is a case report regarding a hemodialysis MDR HIV-infected patient who switched to fostemsavir with lenacapavir plus lamivudine for more than a year. She maintained a suppressed viral replication and presented no clinical or biological drug-related side effects. The combination of lenacapavir plus fostemsavir looks promising regarding safety and efficacy, even in patients with end-stage renal disease awaiting renal transplant. Both drugs are first-in-class ARVs, so there is no cross-resistance with previous drugs, maintaining their efficacy against MDR HIV.

Bigirimana F, Van den Wijngaert S, Fosso C, et al. Lenacapavir with Fostemsavir in a Multidrug-Resistant HIV-Infected Hemodialysis Patient. Case Reports in Infectious Diseases. 2023;2023:8865265. doi:https://doi.org/10.1155/2023/8865265
Cabenuva

The New Era of Long-Acting Antiretroviral Therapy: When and Why to Make the Switch

Despite the availability of safe and effective oral combination antiretroviral therapy, barriers to maintaining viral suppression remain a challenge to ending the HIV epidemic. Long-acting injectable antiretroviral therapy was developed as an alternative to daily oral therapy. This review summarizes the current literature on the efficacy of long-acting cabotegravir plus rilpivirine for the treatment of HIV-1, reasons to switch to injectable therapy, and barriers to switching.

Goebel MC, Guajardo E, Giordano TP, Patel SM. The New Era of Long-Acting Antiretroviral Therapy: When and Why to Make the Switch. Current HIV/AIDS reports. 2023;20(5):271-285. doi:https://doi.org/10.1007/s11904-023-00665-x
Lenacapavir

Lenacapavir: A first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV

The purpose of this article is to review the pharmacology, efficacy, and safety of the capsid inhibitor lenacapavir for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection. A review of the literature was performed by searching PubMed/MEDLINE for all relevant articles published between February 2021 and March 2023 using the keywords “lenacapavir,” “Sunlenca,” “human immunodeficiency virus,” and “treatment” together with “multidrug resistant human immunodeficiency virus.” Lenacapavir is a novel capsid inhibitor indicated, in combination with other antiretroviral therapy, for treatment of multidrug-resistant HIV-1 infection.

Prather C, Lee A, Yen C. Lenacapavir: A first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV. Am J Health Syst Pharm. 2023;80(24):1774-1780. doi:10.1093/ajhp/zxad223 ‌
Cabenuva

Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2 Months is Cost-Effective for the Treatment of HIV-1 in Spain

“Treatment with long-acting (LA) ART may improve adherence and health-related quality of life. The objective of this study was to evaluate the cost-effectiveness of cabotegravir + rilpivirine (CAB+RPV) LA administered every 2 months (Q2M) compared with current ART administered as daily oral single-tablet regimens (STRs) from a Spanish National Healthcare System perspective. This study demonstrated that, in Spain, cabotegravir + rilpivirine long-acting administered every 2 months is a cost-effective alternative to the current daily oral single-tablet treatment options for HIV.”

Moreno S, Rivero A, Pere Ventayol, et al. Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2 Months is Cost-Effective for the Treatment of HIV-1 in Spain. Published online July 14, 2023. doi:https://doi.org/10.1007/s40121-023-00840-y
Cabenuva

Efficacy, safety, and tolerability of switching to long-acting cabotegravir 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

Data support the use of long-acting cabotegravir plus rilpivirine dosed every 2 months as a complete antiretroviral regimen that has similar efficacy to a commonly used integrase strand transfer inhibitor-based first-line regimen while addressing unmet psychosocial issues associated with daily oral treatment.

Moti Ramgopal, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir 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. The Lancet HIV. Published online August 1, 2023. doi:https://doi.org/10.1016/s2352-3018(23)00136-4
Lenacapavir

Long-acting lenacapavir acts as an effective pre-exposure prophylaxis in a 1 rectal SHIV challenge macaque model

Pre-exposure prophylaxis (PrEP) using long-acting antiretroviral medications is a promising new HIV preventive method to daily oral regimens. A first-in-class long-acting capsid inhibitor called lenacapavir (LEN) has been licensed for the treatment of HIV-1 infection. In this study, the authors used a single high-dose simian-human immunodeficiency virus (SHIV) rectal challenge macaque 39 paradigms to evaluate the effectiveness of LEN for PrEP.

Bekerman E, Yant SR, VanderVeen LA, et al. Long-acting lenacapavir acts as an effective pre-exposure prophylaxis in a rectal SHIV challenge macaque model. J Clin Invest. Published online 2023. doi:10.1172/JCI167818
Lenacapavir

Broadly neutralizing antibodies and long-acting antiretroviral drugs as treatments for HIV

Incorporating LA ARVs and bNAbs into regimens has proven to be a challenging task. For the dosage schedules of the two medicines to work together, identical half-lives are required. Additionally, bNAb susceptibility testing is required to ensure that the bNAb is active in order to protect against the possibility of developing resistance to the LA ARV. This has slowed trial enrollment and presents significant logistical challenges for the widespread use of these combinations, should they prove to be safe and effective. To guarantee equal access to these regimens, advancements in delivery technologies and cost-cutting manufacturing are required.

Kuritzkes DR. Broadly neutralizing antibodies and long-acting antiretroviral drugs as treatments for HIV. Curr Opin HIV AIDS. 2023;18(4):225-228. doi:10.1097/COH.0000000000000801
Cabenuva

High Acceptability and Perceived Feasibility of Long-Acting Injectable Antiretroviral Treatment Among People Living with HIV Who Are Viremic and Health Workers in Uganda

The HIV treatment approach known as long-acting injectable antiretroviral therapy (LAI ART), which includes a bimonthly injection of cabotegravir/rilpivirine, appears promising. People who are hesitant to start LAI ART or who adhere to it poorly and who are not virally suppressed may gain the most from it. However, the acceptability and viability of LAI ART among people with viremia in Africa have not been well investigated.

Kennedy CE, Zhao T, Vo AV, et al. High Acceptability and Perceived Feasibility of Long-Acting Injectable Antiretroviral Treatment Among People Living with HIV Who Are Viremic and Health Workers in Uganda. AIDS Patient Care STDS. 2023;37(6):316-322. doi:10.1089/apc.2023.0017
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