The world of HIV treatment has seen a breakthrough with the FDA approval of lenacapavir, an antiretroviral therapy targeting multidrug-resistant HIV.
The drug is revolutionary in its mechanism and offers a new line of attack against an ongoing global health problem.
Targeting the core structure of HIV
Lenacapavir was developed under the supervision of Dr. Onyema Ogbuagu, director of the Yale Antivirals and Vaccines Research Program, develops and acts on the capsid of HIV-1.
The capsid is a conical structure that houses the virus’s RNA and proteins, which are critical for HIV to infect and replicate human cells.
Lenacapavir disrupts this process in two ways: it prevents the HIV genome from reaching the nucleus of an infected cell, thereby blocking replication, and it disrupts the production of new virus particles, causing them to become defective.
A promising solution for drug resistance
Multidrug resistance represents a significant hurdle in HIV treatment and limits the effectiveness of existing antiretroviral drugs.
Lenacapavir addresses this problem head-on, making it a valuable adjunct for patients who have limited treatment options due to drug resistance, intolerance, or safety concerns.
Clinical trials found that the drug suppressed the virus in over 80% of people, a finding Dr. Ogbuagu described as “incredible”.
The process, the dose and the plan for the future
The study included a relatively small group due to the drug’s specific target group – multidrug-resistant HIV patients.
Despite the limited sample size, the FDA deemed recruitment sufficient for approval.
Patients will receive one 927-milligram lenacapavir injection twice a year, while one 300-milligram tablet will serve as a loading dose before switching to injections.
During the height of the COVID-19 pandemic, weekly pills were also used as a “bridge” for those who might miss their injection appointments. However, this form of therapy has not yet received FDA approval.
benefits and security
Data at the end of the first year of the study showed that lenacapavir helped boost the immune system of those treated.
This will likely result in better protection against opportunistic infections such as salmonella and tuberculosis, thus reducing the risk of death.
The drug showed minimal side effects, especially at the injection site, and was well tolerated by patients.
The future of HIV treatment
Lenacapavir represents an important step in HIV treatment, particularly for those who have developed resistance to existing therapies.
The six-month duration of the injection improves treatment adherence, which can be challenging due to social factors such as work schedules and housing insecurity.
In addition, Dr. Ogbuagu that the injection model reduces the stigma associated with taking pills every day.
In summary, the FDA approval of lenacapavir represents a milestone in the fight against HIV and offers patients new hope and improved treatment options.
Future studies are expected to further explore its capabilities, but its impact is already being hailed as a significant advance in the field.
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The study was published in The Lancet HIV.
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