Lencapavir has shown high efficacy in the management of multidrug-resistant cases, providing hope to patients with limited options. A significant breakthrough in the treatment of human immunodeficiency virus (HIV) recently came with the approval of a new prototype drug, lencapavir, by the US Federal Drug Administration (FDA). It uses a unique system of injections twice a year to treat individuals with multidrug-resistant HIV.
The development of lencapavir by Gilead Sciences has been described by the journal Science as a 2024 Breakthrough of the Year.
It said it was “an important step towards reducing HIV/AIDS as a global health crisis.” The introduction of lencapavir is potentially a major step forward in the treatment of HIV/AIDS globally.
This could help achieve the UN Sustainable Development Goal 3 which sets the goal of eliminating HIV/AIDS as a public health threat and moving towards a sustainable HIV response after 2030.
This breakthrough comes as HIV/AIDS remains a formidable global public health challenge since its discovery in the early 1980s.
Initially identified in the United States, HIV/AIDS has since killed more than 42 million people and infected more than 88 million people worldwide. Globally, 39.9 million people were living with AIDS at the end of 2023.
While advances in antiretroviral therapy (ART, a combination of HIV drugs that treat people infected with the virus) have transformed the management of HIV, it continues to pose significant challenges, especially for individuals with multidrug-resistant strains of the virus. Used to be.
HIV originated by zoonotic transmission, possibly spreading from non-human primates to humans in Central and West Africa in the early 20th century.
However, it was not until 1983 that French researchers identified the virus that would later become known as AIDS (Acquired Immunodeficiency Syndrome).
It marked the beginning of the global battle against a virus that destroys the immune system, leaving individuals vulnerable to opportunistic infections and some cancers.
Antiretroviral therapy, first introduced with the FDA approval of AZT in 1987, was a turning point in HIV treatment. More than 50 antiretroviral drugs are now FDA-approved, offering many options to effectively manage the virus.
Despite these advances, HIV remains incurable, and many patients face challenges such as drug resistance, requiring new therapeutic innovations.
To understand the impact of HIV, it helps to compare it to the recent COVID-19 pandemic.
COVID-19, which is largely preventable through vaccines and treatments, is different from AIDS, which is incurable and can only be managed with antiretroviral therapy.
COVID-19 spread rapidly, causing more than seven million deaths worldwide in a short period of time. Respiratory viruses like SARS-CoV-2, which causes COVID-19, have been well studied, and targets for vaccine development have been well characterized.
In contrast, HIV’s high mutation rate, integration into human DNA, and long latency period have made vaccine development extremely challenging.
Unlike COVID-19, which primarily causes severe disease, HIV gradually weakens the immune system, leading to chronic susceptibility to infections such as tuberculosis, resulting in a far higher death rate. It happens.
Efforts to fight HIV are further complicated by stigma and discrimination, especially among marginalized communities.
It is estimated that sub-Saharan Africa, home to 15 percent of the global population, has two-thirds of people living with HIV. Approximately 4,000 adolescent girls and young women are infected with HIV every week (2022 figures).
In this context, the FDA approval of lencapavir, a first-in-class drug designed for individuals with multidrug-resistant HIV, is truly a breakthrough.
The efficacy of lencapavir was demonstrated through extensive clinical trials conducted globally, including several countries in Latin America, South Africa, Thailand, and the United States.
Details of the clinical trial study (called PUPOSE 2) conducted by Gilead state, “Lenacapavir was highly effective in reducing HIV infections among trial participants: 99.9% of participants did not acquire HIV in the lencapavir group.” “, there were two incident cases among 2,179 participants (0.10/100 person-years, 95% CI, 0.01 to 0.37).” The study claims this was despite reports of high levels of sexual behaviour, chemsex and sexually transmitted infections among the 2 participants.
The trials highlighted its ability to significantly reduce viral load, especially in patients who had exhausted other treatment options.
Lencapavir has shown high efficacy in the management of multidrug-resistant cases, providing hope to patients with limited options.
The process of administering lencapavir involves an initial oral loading dose, followed by subcutaneous injections every six months. Lencapavir works by targeting the HIV capsid, a protein shell that protects the genetic material of the virus.
This medication is not a standalone therapy and must be used in combination with other antiretroviral medications to ensure comprehensive viral suppression.
Due to its innovative mechanism of action and extended dosing schedule, it has been described as a pioneering advancement in HIV care and is being introduced as an early vaccine-like innovation in HIV treatment, providing extended viral suppression Which reduces the burden of daily treatment.
This simplified regimen improves adherence and reduces the risk of treatment failure due to missed doses.
However, particularly in low- and middle-income countries, where the burden of HIV infection is high, a major challenge to the widespread use of lencapavir is primarily due to its current cost.
Initial pricing has indicated significant disparities, leading to calls for subsidies and international cooperation to make the drug accessible to those who need it most.
Already, the Global Fund to Fight AIDS has joined forces with several other foundations in a coordinated effort to provide affordable and equitable access to the twice-yearly injectable drug.
It will be “subject to regulatory approval from the US Food and Drug Administration, relevant national pharmaceutical regulators, and recommendation from the World Health Organization (WHO).” However, the FDA has now approved the drug. Lencapavir is also approved in several countries to treat adults who have multidrug-resistant HIV, used in combination with other antiretroviral drugs.
There are signs that the drug may also prevent new HIV infections. In October this year, Gilead announced that it had entered into a non-profit partnership with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lencapavir for HIV prevention to 120 people, primarily at low and low-risk groups. -Signed an exclusive, royalty-free voluntary license. middle-income countries.” While the development of lencapavir is a major innovative step in the fight against HIV, it also underlines the importance and need for continued research into more effective treatments against HIV, including anti-HIV vaccine innovation and equitable health care policies. Is.
The fight against HIV continues, but lencapavir promises better management of the infection.
,Author, Virendra Singh Chauhan is Chancellor of GITAM University, Arturo Falaschi Emeritus Scientist, International Center for Genetic Engineering and Biotechnology, New Delhi and Distinguished Visiting Professor, Institution of Excellence Delhi University)
Disclaimer: Originally published under creative Commons By 360 information™.
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