Approved Medications Research
- All
- Apretude
- Cabenuva
- Lenacapavir
- Trogarzo
Current status of the small molecule anti-HIV drugs in the pipeline or recently approved
HIV/AIDs presents significant treatment challenges due to increasing resistance to current antiretroviral drugs. This resistance is exacerbated in low- and middle-income countries due to drug misuse, inadequate drug supply, and poor treatment monitoring. Despite these challenges, there has been progress in developing new ARV drugs targeting various components of HIV. This review, updated as of July 2024, provides an overview of new ARV drugs at different clinical trial stages. It discusses the mechanism of action, target biomolecule, associated resistance genes, efficacy, safety, drug class, and clinical trial phase for each compound. The review covers nucleoside reverse transcriptase inhibitors (NRTIs) like islatravir ; non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as rilpivirine, elsulfavirine, and doravirine; integrase inhibitors like cabotegravir and dolutegravir.
Nongnuj P, Torkin R, Azzarito V, et al. Current status of the small molecule anti-HIV drugs in the pipeline or recently approved. Bioorganic & Medicinal Chemistry. 2024;32:117860. doi:10.1016/j.bmc.2024.117860.
Identifying Implementation Determinants and Strategies for Long-Acting Injectable Cabotegravir–Rilpivirine in People With HIV Who Are Virally Unsuppressed
According to preliminary data, individuals with HIV who are not able to achieve viral suppression with oral treatments may benefit from long-acting injectable cabotegravir and rilpivirine (LA-CAB/RPV). Utilizing the Consolidated Framework for Implementation Research, a research conducted at Ward 86 in San Francisco examined patient, provider, and contextual characteristics that impact the implementation of LA-CAB/RPV.
Hickey MD, Grochowski J, Mayorga-Munoz F, et al. Identifying implementation determinants and strategies for long-acting injectable cabotegravir–rilpivirine in people with HIV who are virally unsuppressed. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2024;96(3):280-289. doi:10.1097/QAI.0000000000003421.
Long-Acting Injectable Pre-Exposure Prophylaxis Perceptions and Preferences Among Transgender and Nonbinary Young Adults in the United States
The United States legalized the use of long-acting injectable pre-exposure prophylaxis for HIV prevention (LAI-PrEP) in 2021. However, little is known about how transgender and nonbinary young adults, a population that faces significant obstacles to HIV prevention, see LAI-PrEP. The study looks at this population’s perceptions of long-acting injectable PrEP’s acceptability, convenience, and efficacy compared to other preventative strategies. It pinpoints the main elements affecting individual preferences, including accessibility, stigma, and side effect concerns. The results are intended to guide the development of better PrEP adoption tactics and the customization of preventative initiatives better to serve the needs of transgender and nonbinary people.
Gordon AR, Haiken S, Murchison GR, Agénor M, Hughto JMW, Nelson KM. Long-Acting Injectable Pre-Exposure Prophylaxis Perceptions and Preferences Among Transgender and Nonbinary Young Adults in the United States. Qualitative Health Research. 2024;0(0). doi:10.1177/10497323241265943
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women
For the prevention of HIV in cisgender women, there are variations in the uptake, adherence, and durability of preexposure prophylaxis. This study tested the effectiveness of subcutaneous lenacapavir and daily oral emtricitabine–tenofovir alafenamide (F/TAF) versus daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF) in preventing HIV among adolescent girls and young women in South Africa and Uganda.
Pintye HM, Shapiro RJL, DeBeck MA, et al. Efficacy and safety of lenacapavir vs emtricitabine–tenofovir for HIV prevention. N Engl J Med. 2024;391(1):67-78. doi:10.1056/NEJMoa2407001.
Consensus recommendations for use of long-acting antiretroviral medications in the treatment and prevention of HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy, Canadian HIV and Viral Hepatitis Pharmacists Network, European AIDS Clinical Society, and Society of Infectious Diseases Pharmacists: An executive summary
Five long-acting (LA) antiretrovirals (ARVs)—cabotegravir, rilpivirine, lenacapavir, ibalizumab, and dapivirine—are now available in a few countries for HIV-1 prevention and treatment. To integrate LA ARVs into routine clinical practice, significant changes in HIV-1 care are needed. Consensus recommendations will guide doctors in the effective and safe use of these new, complex agents. These guidelines aim to support clinical use and outline future research directions.
Sherman EM, Agwu AL, Ambrosioni J, et al. Consensus recommendations for use of long-acting antiretroviral medications in the treatment and prevention of HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy, Canadian HIV and Viral Hepatitis Pharmacists Network, European AIDS Clinical Society, and Society of Infectious Diseases Pharmacists: An executive summary. Pharmacotherapy. 2024; 44: 488-493. doi:10.1002/phar.2921
Identification of Determinants and Implementation Strategies to Increase Long-Acting Injectable PrEP for HIV Prevention Among Latino Men Who Have Sex with Men (MSM)
In the United States, HIV infections disproportionately afflict Latino men who have sex with men (LMSM). Pre-exposure prophylaxis, or PrEP, has not been widely adopted by LMSM as a means of preventing HIV. Injectable PrEP with a long half-life (LAI-PrEP) may help with behavioral, cognitive, and structural adherence difficulties. The purpose of our study was to investigate the experiences and attitudes of LMSM regarding LAI-PrEP and identify implementation barriers in comparison to the standard oral presentation. We also aimed to align suggested implementation strategies and propose outcomes to monitor and assess impact, given the potential benefits of LAI-PrEP and the paucity of data with this population.
Zapata, J.P., zamantakis, a. & Queiroz, A.A.F.L.N. Identification of Determinants and Implementation Strategies to Increase Long-Acting Injectable PrEP for HIV Prevention Among Latino Men Who Have Sex with Men (MSM). J. Racial and Ethnic Health Disparities 11, 2093–2102 (2024). https://doi.org/10.1007/s40615-023-01678-3
Innovative Team Approach to Sexual Health Counseling; Partnership of Urology, Infectious Disease and Pelvic Floor Therapy to Increase Access to Care
Pre-exposure prophylaxis (PrEP) is one HIV preventive strategy that is widely used, yet AIDS cases still outnumber treatment and prevention attempts. Significant obstacles still exist, including stigma, prejudice, and lack of access, especially for vulnerable populations like women, minorities, and LGBTQ people. In order to address these problems through a comprehensive approach to sexual health medicine, the study offers a novel technique that combines urology, infectious disease, and pelvic floor therapy with the goal of improving patient outcomes and access to care.
Jackson C, Hakky T, Tims-Cook Z, Frank L. Innovative team approach to sexual health counseling: Partnership of urology, infectious disease, and pelvic floor therapy to increase access to care. J Sex Med. 2024;21(Suppl 1)
.267. doi:10.1093/jsxmed/qdae001.267
Evidence Suggest Long-Acting Injectables Game Changer for Adherence
There is emerging evidence that long-acting injectable therapies, such as rilpivirine and cabotegravir, may offer significant benefits for people with HIV, especially those who struggle with adherence to daily oral medications. These injections, administered every few months, could improve adherence and provide a more convenient alternative to daily pills. The article highlights ongoing challenges, including issues related to cost, accessibility, and the need for continued patient education and support to ensure these therapies are used effectively.
Simons R. Evidence suggests long-acting injectable therapies could benefit people with HIV. ADAP Advocacy Association. Published February 2024. https://adapadvocacyassociation.blogspot.com/2024/02/evidence-suggest-long-acting.html.
Treatment and Prevention of HIV Infection: Recommendations From the International Antiviral Society-USA Panel
Early diagnosis, consistent treatment, and patient education are extremely important in managing HIV and preventing its spread. The article discusses the updated guidelines for treating and preventing HIV infection, focusing on the latest recommendations for antiretroviral therapy and preventive measures like pre-exposure prophylaxis (PrEP). The article also outlines strategies to enhance adherence to these guidelines and improve overall patient care.
Here is the AMA citation for the article:
American Academy of Family Physicians. Practice guidelines for the treatment and prevention of HIV infection. Am Fam Physician. 2024;109(1):62-64. https://www.aafp.org/pubs/afp/issues/2024/0100/practice-guidelines-treatment-prevention-hiv-infection.html
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
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
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:
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