Latest news with #N.Kumarasamy
The Hindu
2 days ago
- Health
- The Hindu
Should HIV/AIDS testing be made mandatory before marriage?
In July, Meghalaya Health and Family Welfare Minister Mazel Ampareen Lyngdoh announced that the State may follow Goa in making HIV/AIDS test mandatory for all before marriage. The problem is multi-disciplinary; it is not merely a question of health, but also involves considerations of human rights, stigma, and free will. Should HIV/AIDS testing be made mandatory? N. Kumarasamy and Jahnabi Goswami discuss the question in a conversation moderated by Ramya Kannan. Edited excerpts: Is it possible to implement mandatory testing for HIV before marriage? What are the advantages of such a move? N. Kumarasamy: Regarding HIV, making anything mandatory is not acceptable. The HIV and AIDS (Prevention and Control) Act, 2017, clearly mandates counselling before testing, and testing only with the consent of a patient. As per the law of the land, once you do the testing, everything must be kept confidential. If they test positive, patients should be linked to the appropriate antiretroviral treatment centres. The next question will be whether they can get married — that has also been dealt with by the 2017 law. Today, based on science, we know that if a HIV-positive person is put on antiretroviral treatment, the viral load goes to an undetectable level within 2-3 months. Studies have shown that a person who has an undetectable level of viral load will not transmit infections sexually to their partners. The person will also not develop any HIV-related complications such as opportunistic infections, tuberculosis (TB), and various other comorbid conditions, and maintain a normal immunity level. Mandatory HIV testing without the consent of such a person will be a human rights violation. And doing so will also increase stigma. For all these reasons, mandatory testing cannot take place. HIV testing should be offered to as many people as possible — mainly to those who are at risk and also people who believe that they may be at risk. It should be offered. Consent is important. And testing, if done, should be done while maintaining appropriate confidentiality. Jahnabi Goswami: Yes, the viral load can be managed with drugs. But I still think HIV testing should be made mandatory before marriage. There are a number of cases we know where people who have been infected, but are not taking antiretrovirals regularly, get married because of family and societal pressure. The spouse finds out only later, or perhaps when she or he tests positive for HIV. The children are likely to be affected too. In India we believe in matching horoscopes before the wedding. Why not a HIV test, to see if the couple are compatible at all? Such a test will also ensure the health of the family. Will this move actually empower women? Jahnabi Goswami: My agenda is not women or male empowerment per se. In the north-east, specifically, there have been a number of cases where the (HIV positive) status was concealed. Injecting drug use is responsible for nearly 64% of HIV infections in the north-east. Men (injecting drug users) clean up for three months, get married and don't inform their wives. A few months later, they bring their wives too to test. Even today, we had such a case. This happens regularly. In fact, I believe that to safeguard women and girls, it is essential to go in for mandatory testing, with counselling. About confidentiality and consent, I want to point out that in practice, doctors are forcefully testing for HIV. Even if you go for a small dental procedure — sometimes they counsel, sometimes they don't, and force you to do HIV test. Sometimes it is good counselling and sometimes it is of bad quality. Will the HIV test, if it comes negative, provide a false sense of security? N. Kumarasamy: While you are doing appropriate testing, you are also counselling a patient to find out the duration of exposure. That also helps you determine the window period when testing should be offered. That is the reason you counsel someone. If you force someone to do a test, they may go to a lab and get it done. The test report can be negative but the person might really be positive (for HIV) leading to transmission of infection. If testing is done with appropriate consent, counselling, and confidentiality, I'm sure people are not going to refuse it. Goa also proposed mandatory testing some years ago, but it is still not a reality... N. Kumarasamy: Yes, it is not implemented in Goa. But there is wide testing happening in the State. There is no mandatory testing before a wedding. The thing is they cannot implement this because this will cause human rights violations. The same thing is happening in Meghalaya. If you look at the reports on rising infections, perhaps the State is ranked 5th or 6th where a significant number of infections is through injecting drug use and also through sexual contact. But I think it is possible to learn from other States, especially from southern India — Tamil Nadu, Kerala, and Andhra Pradesh — as well as Maharashtra. The ideal way to contain this infection is to do appropriate HIV testing as much as possible in a variety of settings with proper consent and then link those tested people to the treatment. That will reduce infectiousness in the country and also lead to a reduction in new infections in Meghalaya. Jahnabi Goswami: I think it will definitely happen because the situation is quite different in Meghalaya. To understand it, you should understand the circumstances and people of the State. In Meghalaya, certain groups in the Christian community still think it is taboo to use a condom even if it is recommended by law. (The HIV Act promotes safe sex practices.) In fact, implementing the HIV/AIDS Act in Meghalaya is really difficult. Also, culturally and socially, they have provisions for extramarital affairs and living together. These are quite common among the youth. Simultaneously, HIV is a big discriminator in Meghalaya and no one has actually accepts HIV-positive men or women. How do we address the stigma that is still associated with HIV? N. Kumarasamy: Stigma started in India because it (HIV) was first detected in a commercial sex worker, so it was attributed to multi-partner sex. But this is not true, as we have seen. HIV is still an incurable disease. The way to address stigma today is to make sure that common people are aware that we now have treatment available. Even if it is not curable, it is permanently controllable. In our research studies in Chennai, we showed that treating one partner will prevent transmission if the viral load goes down. The message U=U (undetectable is untransmittable) does work. Such scientific messages can remove stigma from the community, so that as many people as possible will test and be linked to treatment. Someone who is already on treatment will do well, and not transmit infection to the others. Addressing stigma is not an easy thing. Over 30 years of taking care of people with HIV and their families at our centre here, we realise that each one is different. Much is based on their education, how they were raised, and whether they live in the village or city. All this will have to be wrapped up in several rounds of counselling. Jahnabi Goswami: As Dr. Kumarasamy has said, stigma is associated not with the disease, but with where the infection arises from. The impression is that people who are in sex work will get HIV; people who do drugs will get HIV. That is where the stigma comes from. We should constantly try to reduce stigma. The government, people who are infected, like me, and those working in the field should work hard to erode the stigma. If someone has cancer, they say without any hesitation that their family members died of cancer. If they are diabetic, they say they don't use sugar. And if they have hypertension, they don't mind asking you not to put salt in their food. But people who have HIV or people who have TB do not talk openly about it because these are seen as behavioral issues. We must remove the stigma and make it comfortable for HIV-positive people to talk about their status. I do believe we have to involve counsellors to tell people that they will not transmit because they are on treatment, that U=U; and involve more people with HIV as role models to reduce stigma and discrimination. The quality of counselling should be improved for sure. Listen to the conversation
The Hindu
27-07-2025
- Health
- The Hindu
Lenacapavir: After FDA approval, HIV pre-exposure prophylaxis injectable moving closer to EU approval
On July 25, The European Medicines Agency (EMA)'s advisory committee recommended Gilead Sciences' Lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. Any recommendation by EMA's advisory committee has to be formally approved by the European Commission, which is expected later this year. The recommendation by the EMA's advisory committee comes about a month after the U.S. FDA on June 18, 2025 approved the injectable HIV-1 capsid inhibitor as a pre-exposure prophylaxis (PrEP). The World Health Organization welcomed the approval by FDA on June 19 and issued guidelines for use of Lenacapavir for HIV prevention on July 14. 'Offering additional pre-exposure prophylaxis (PrEP) choices has the potential to increase uptake and effective use of PrEP, and of HIV prevention overall, as it allows people to choose a method that they prefer,' the guidelines say. Studies have also shown that Lenacapavir can achieve significant viral suppression, even in cases where other drugs have failed. The FDA approved Lenacapavir is based on the 2024 results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated the safety and efficacy of the pre-exposure prophylaxis injectable across diverse populations and settings. The PURPOSE 1 was a Phase 3, double-blind, randomised trial to evaluate the safety and efficacy of twice-yearly, subcutaneous Lenacapavir for pre-exposure prophylaxis (PrEP) and was tested on 5,338 cisgender women and adolescent girls aged 16-25 across 25 sites in South Africa and three sites in Uganda. The injectable was compared with an active control arm that received once-daily oral pre-exposure prophylaxis drug Truvada (emtricitabine-tenofovir disoproxil fumarate; F/TDF). There were zero HIV infections among 2,134 participants in the Lenacapavir group, while the active control group had 39 infections among 2,136 participants. In the PURPOSE 2 Phase-3 trial involving 3,265 participants in the modified intention-to-treat analysis, two participants were infected with HIV in the arm that received the injectable, while nine participants who received the active control PrEP oral drug Truvada (emtricitabine-tenofovir disoproxil fumarate; F/TDF) were infected. The background HIV incidence in the screened population (4,634 participants) was 2.37 per 100 person-years. The trial was carried out in of cisgender men, transgender, and nonbinary individuals across 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the U.S. Compared with the generic PrEP oral drug Truvada, which is extremely inexpensive and widely available, Lenacapavir costs $28,000 for two injections. Why would people ever prefer to use Lenacapavir considering the cost? 'Oral PrEP will be effective only if there is 100% adherence. The oral drug won't work even if it is missed for a day because the drug level will be only 24 hours,' says Dr. N. Kumarasamy, Chief and Director, VHS-Infectious Diseases Medical Centre, Voluntary Health Services, Chennai. 'People who have the highest risk such as sex workers and gay men have to take the drug every day. Taking a tablet every day, even for a deceased patient, is so difficult. They tend to miss a dose, which is why adherence is never 100%,' he says. 'Even in the case of on-demand PrEP, where people who want to indulge in unprotected sex have to take the oral drug two days before, then throughout the period of risky behaviour and continue for two more days after risky behaviour ends, adherence never goes beyond 85-90%. PrEP will work only if the adherence is 100%.' According to Dr. Kumarasamy, despite the oral tablet being inexpensive and easy to take, the adherence is less than ideal, the reason why people are moving towards long-acting injectables that prevent HIV infection for months after an injection. Cabotegravir, which was developed as pre-exposure prophylaxis (PrEP), underwent trials in many countries and was approved for use. Cabotegravir, which is administered intramuscularly every two months, was found superior compared with every day oral PrEP tablet, and started getting implemented in certain parts of the world, Dr. Kumarasamy says. 'Since Cabotegravir has to be administered every two months, people tend to forget. The new drug Lanacapivir has been found to be effective for six months in the trials. The injectable was developed in 2021 as treatment in people who no longer respond to other drugs as they have developed resistance,' he says. Because Lenacapavir was found to be long-acting, it was repurposed as a pre-exposure prophylaxis administered subcutaneously. 'Lenacapavir is a robust molecule and is the best solution in the absence of vaccines. Even if there is going to be an HIV vaccine one day, I'm sure people will have to take the vaccine every year or something. Like a flu shot, you know if at all they are going to develop a vaccine, people may have to take it every year or every six months as a booster dose. It may not be like a one dose that is effective for years,' Dr. Kumarasamy says. 'In the absence of a HIV vaccine, I think the pre-exposure prophylaxis every six months can be considered like a vaccine.' Gilead is developing the same molecule to be administered once a year instead of every six months. They are already working on that. But it will not be a subcutaneous form but as an intramuscular injection, he says. Licensing agreements On October 2, 2024, Gilead Sciences signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic Lenacapavir. Of the six generic manufacturers, four are in India. Besides signing agreement to license generic manufacturers to make the injectable, Gilead Sciences also said that it would 'support low-cost access to the drug in high-incidence, resource-limited countries at no profit until generic manufacturers are able to fully support demand'. These countries are: Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe. The company has licensed Dr. Reddy's Laboratories Limited, Emcure, Hetero and Mylan, a subsidiary of Viatris, to manufacture Lenacapavir in India. The companies will be permitted to supply to 120 countries. According to the press release, the agreements cover not only Lenacapavir for HIV prevention but also for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV. According to Dr. Kumarasamy one company has already started developing the drug and Lenacapavir may become available next year once the Indian drug regulator approves it based on the results of a safety study carried out in India. As per his estimate, the generic form of Lenacapavir will cost about $100 per dose.
