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US FDA approves HIV prevention drug: Why is this a breakthrough?
A twice-yearly injectable drug for the prevention of HIV infection has been approved by the United States' Food and Drug Administration. With better compliance expected — instead of daily pills on a shot every two months that people have to take at the moment — it is one of the most anticipated developments in the field of HIV prevention.
The Lenacapavir injection — sold as Yeztugo by pharmaceutical giant Gilead — was approved based on the results of two Phase 3 trials that showed 99.9% of individuals remained HIV negative with the two shots taken annually. 'FDA approval … paves the way for WHO prequalification, which can accelerate national regulatory approvals … and procurement by donor agencies like the Global Fund… Lenacapavir's discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits and stigma associated with HIV prevention,' the World Health Organization (WHO) said.
Lenacapavir is an anti-retroviral medication that can be used to treat as well as prevent HIV. As Sunlenca, it is used in combination with other antiretroviral drugs for the treatment of people who have been on pills for a very long time and are resistant to multiple drugs. As Yestugo, it is a pre-exposure prophylaxis (PrEP) to prevent the infection.
The drug works by binding with the HIV capsid — a protein shell that protects the virus' genetic material. It then disrupts crucial steps needed for the virus to replicate and infect new cells.
PrEP or pre-exposure prophylaxis is a drug or injectable meant to prevent HIV infection in people at a higher risk of contracting the disease. These medicines can reduce the risk of acquiring HIV infection through sexual activity by 99% and through injection drug use by 74%.
At present, there are several types of PrEP available — pills such as Truvada or Descovy, Dapivirine vaginal ring and the injectable Cabotegravir that has to be taken every two months.
It is important to be tested for HIV before taking PrEP. While these medicines are also used in the treatment of HIV, they are prescribed in combination with other antiretrovirals. Given alone to a patient with HIV, they might develop resistance to the drugs.
PrEP is usually recommended for people living with an HIV positive partner, those who frequently change partners, those who have sex with people with unknown HIV status, those who work in the sex industry, and those who use injectable drugs. Medicines for post exposure prophylaxis are also available to be used as an emergency measure in cases such as inadvertent exposure in a hospital setting, after condom failure, or during sexual assault.
While generic versions of the PrEP pills are approved in India — Cabotegravir injection is also available through a sub-licensing contract — they are not widely used.
This is mainly owing to the cost of the medicines and the fact that they are not yet part of the country's national programme, which already provides life-long treatment to all who have been diagnosed with HIV. The new injectable will cost USD 28,218 annually, remaining out of reach for many.
Even in the US, usage remains low. Only 36% of the 1.2 million people who would have benefited from the medicine were prescribed it.
Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme.
Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports.
Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan.
She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times.
When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
