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In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.

British drugmaker GSK has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where the majority of new HIV cases occur. The injected drug cabotegravir is approved by regulators in Britain and the United States. Last July, GSK announced a program with the United Nations-backed healthcare organisation, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines. During the HIV/AIDs epidemic in Africa in the 1990s and early 2000s, in which many millions of people died, treatments used widely in wealthy countries were unavailable on the continent. GSK said last year the new program could result in the generic form of its injection being available in lower-income countries beginning in 2026. The drugmaker's HIV treatment division, ViiV Healthcare, said in a statement on Wednesday it had issued voluntary licenses - waiving intellectual property rights - to Aurobindo, Cipla and Viatris, which will manufacture the generic versions of injectable cabotegravir.

In its first, the National Institute for Health and Care Excellence has recommended the use of long-acting injectable treatment for HIV-1 infection in adults, making around 13,000 people eligible for treatment with cabotegravir with rilpivirine in England. The new treatment aims to keep the number of virus particles in the blood so low that it cannot be detected or transmitted between people. Current treatment for HIV‑1 is lifelong antiretroviral tablets taken each day. Use of cabotegravir with rilpivirine is recommended when there is no evidence tosuspect viral resistance, and no previous failure of other anti-HIV-1 medicines. "Clinical trial results show that cabotegravir with rilpivirine is as effective as oralantiretrovirals at keeping the viral load low," NICE stated. Both are administered as two separate injections every two months, after an initial oral (tablet) lead-in period.