By: Ranier Simons, ADAP Blog Guest Contributor
The road to successful drug development is a long one. The approval of a new drug is a result of rigorous science and various phases of clinical trials in humans to prove its safety and efficacy. However, once a drug is approved and entered standard practice, the road does not end there. It is necessary to continue clinical trials to support a drug’s ongoing usage and emphasize its strengths and weaknesses. That is why recent data concerning lenacapavir is so encouraging. Data shows that its efficacy is long-lasting.[1]
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Lenacapavir’s continuing success was presented in October at the IDWeek annual meeting in Los Angeles. IDWeek is an annual international conference of healthcare professionals working with infectious diseases. At the conference, individuals such as researchers, clinicians, and public health officials, including those involved with treating HIV patients, collaborate and learn.[1] Third-year results of the CAPELLA study were presented, indicating long-term viral suppression achieved by those remaining in the study.[2]
The CAPELLA study led to lenacapavir being approved for use in the United States.[3] Under the brand name Sunlenca, lenacapavir is used to treat people who have multi-drug resistance to HIV antiretroviral medications. People living with HIV who have failed drug regimens are in a precarious situation, being unable to effectively control their HIV and achieve viral suppression. Lenacapavir is a subcutaneous infection administered twice a year in addition to an optimized regimen of other antiviral HIV medications. The CAPELLA clinical trial proved the efficacy of lenacapavir. The suppression shown in year two of the study continues in year three.
From year two to year three, viral suppression remained high, and there have been no treatment failures, which are defined as loss of viral suppression. Additionally, the CD4 counts of the participants continue to rise. Most importantly, no new cases of lenacapavir resistance have been seen. Earlier in the study, there were about 14 cases of lenacapavir-associated resistance.[2] This was attributed to issues such as non-adherence and an ineffective optimized background regimen (OBR). Lenacapavir is taken in addition to other antiviral medication. For lenacapavir to succeed, patients must maintain an effective OBR that works with their bodies. A patient’s OBR is based on their treatment history and other clinical test results involving resistance and pharmacological concerns. The best chance of success with any drug added to a failed regimen is an effective OBR.[4]
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The significance of the success of lenacapavir is that it is a long-acting injectable that is only administered twice a year. There are two other medications approved to help those living with multi-drug HIV resistance: fostemsavir and ibalizumab. However, fostemasavir is a twice-daily oral pill, and ibalizumab is an injection given every two weeks.[5] The twice-daily pill has more potential for adverse drug interactions, and both two medications are more demanding in terms of the logistics of treatment adherence. Requiring a patient to keep up with two additional daily pills in a multi-drug regimen or maintaining visits to receive a bi-weekly injection is more prone to non-adherence compared to a semi-annual injection like lenacapavir.
As the CAPELLA study continues, the hope is that the results continue to be favorable. Having an effective and convenient treatment for those living with multi-drug resistance is imperative. Ongoing success with lenacapavir will also support efforts to research and invest in future long-term injectable therapies. As more long-term injectable therapies arise, their success will prove their utility to the insurance industry. Hopefully, this will result in funding innovation to enable widespread access to those in need of these life-saving drugs.
[1] Laub, G. (2024, November 20). Sustained Viral Suppression in Multidrug-Resistant HIV With Lenacapavir at 3 Years. Retrieved fromhttps://www.medpagetoday.com/meetingcoverage/idweekvideopearls/113019
[2] Mascolini, M. (2024, October 20). Lenacapavir Sustains HIV Control and Keeps Boosting CD4s Through 3 Years. Retrieved from https://www.natap.org/2024/IDWeek/IDWeek_06.htm
[3] Segal-Maurer, S., DeJesus, E., Stellbrink, H.-J., Castagna, A., Richmond, G. J., Sinclair, G. I., Siripassorn, K., Ruane, P. J., Berhe, M., Wang, H., Margot, N. A., Dvory-Sobol, H., Hyland, R. H., Brainard, D. M., Rhee, M. S., Baeten, J. M., & Molina, J.-M. (2022). Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. New England Journal of Medicine, 386(19), 1793–1803. https://doi.org/10.1056/nejmoa2115542
[4] CLinical Info HIV.GOV. (n.d.) HIV/AIDS Glossary: Optimized Background Therapy. Retrieved from https://clinicalinfo.hiv.gov/en/glossary/optimized-background-therapy-obt
[5] Cluck, D. B., Chastain, D. B., Murray, M., Durham, S. H., Chahine, E. B., Derrick, C., Dumond, J. B., Hester, E. K., Jeter, S. B., Johnson, M. D., Kilcrease, C., Kufel, W. D., Kwong, J., Ladak, A. F., Patel, N., Pérez, S. E., Poe, J. B., Bolch, C., Thomas, I., & Asiago‐Reddy, E. (2024). Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment‐experienced and/or have multidrug‐resistant HIV‐1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy. Pharmacotherapy the Journal of Human Pharmacology and Drug Therapy, 44(5), 360–382. https://doi.org/10.1002/phar.2914
Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.
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