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A clinical study in seven European countries is comparing the effectiveness of two HIV drugs in people with advanced disease for the first time.
Around 40 million people worldwide are living with HIV infection. In the United Kingdom, there are approximately 100,000 people affected. If the infection is not treated, the body will eventually be unable to defend itself against pathogens or tumour cells. This leads to acquired immunodeficiency syndrome, which causes several diseases, some of which are life-threatening. HIV infection can now be treated effectively. If therapy is started early enough, those affected have a completely normal life expectancy. However, how drugs work in people with advanced HIV disease has not yet been scientifically proven – until now. In a comprehensive clinical study led by Professor Georg Behrens, senior physician at the Department for Rheumatology and Immunology at Hannover Medical School (MHH), researchers from 56 medical centres in Belgium, Germany, France, Great Britain, Ireland, Italy and Spain focused on this patient group and investigated which drugs work best in severely ill patients. The results have been published on 1 December, World AIDS Day, in the renowned journal ‘The Lancet Infection Diseases’.
Late presenters have fewer immune cells
The HI virus belongs to the group of retroviruses, which transcribe their genetic material into DNA using their own enzyme and incorporate it into the genome of the host cell. HI viruses primarily attack CD4 cells in the immune system. These white blood cells, also known as T helper cells, activate defence cells and thus control the immune system in the event of infection. The number of CD4 cells can therefore be used to determine how severely HIV has already damaged the immune system. In healthy people, the number is between 500 and 1500 T helper cells per microlitre of blood. In people with a late HIV diagnosis – also known as ‘late presenters’ – the number is less than 350 CD4 cells per microlitre. The weakened immune system leads to progressive disease with a poor long-term prognosis and increases the risk of dying from AIDS.
Virus replication prevented
The LAPTOP (Late Presenter Treatment Optimisation) clinical trial focuses on this group, which accounts for around 50 per cent of HIV-infected individuals. The researchers compared two antiretroviral drugs used in first-line therapy – i.e. two anti-HIV drugs that are recognised and proven to be the best initial treatment for this disease, at least in HIV-infected individuals in the early stages. ‘We wanted to scientifically investigate the efficacy and safety of integrase inhibitor therapy and enhanced protease inhibitor therapy for the first time in HIV-infected individuals diagnosed at a late stage,’ says Professor Behrens, immunologist and head of the working group ‘Adaptive Immunity in Infections and Autoimmune Diseases’. Integrase inhibitors block the enzyme that the virus uses to insert its genetic material into the DNA of the human host cell. Protease inhibitors prevent the formation of important viral proteins, thereby interrupting the pathogen's life cycle. Both drugs thus ensure in different ways that the virus cannot multiply and infect further cells.
Integrase inhibitors recommended as first-line therapy
Around 450 newly diagnosed adults with advanced HIV disease were included in the study. Participants were randomly assigned to receive either integrase inhibitors or protease inhibitors as treatment. ‘Our study is the first large randomised controlled trial to compare the antiviral efficacy, recovery of the compromised immune system and possible side effects of first-line antiretroviral therapies specifically in people with advanced HIV disease,’ emphasises Professor Behrens. The integrase inhibitor was not inferior in the study, suppressed viral replication even more effectively and had fewer side effects. ‘This is the first scientific proof that the drug works well even in advanced HIV disease with CD4 cells below 50 per microlitre, and we therefore recommend the integrase inhibitor as the preferred first-line therapy for these patients.’
For further information please ask Professor Georg Behrens, behrens.georg@mh-hannover.de, telephone +49 511 532-5713.
The original paper „Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry randomized, open-label, non-inferiority trial” can be found here: https://doi.org/10.1016/S1473-3099(25)00681-4
Effective and safe, even with late diagnosis: MHH study examines two antiretroviral drugs in people ...
Source: Karin Kaiser
Copyright: Karin Kaiser/MHH
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Effective and safe, even with late diagnosis: MHH study examines two antiretroviral drugs in people ...
Source: Karin Kaiser
Copyright: Karin Kaiser/MHH
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