Clinical study shows effectiveness of HIV drugs in advanced disease

by | Dec 2, 2025 | Health, Research

An international study led by the Hannover Medical School (MHH) has compared the effectiveness of two HIV drugs in people with advanced infection for the first time. The results, which were published yesterday in the journal “The Lancet Infectious Diseases” on World AIDS Day, come from 56 centers in seven European countries and could improve the treatment of severe cases.

Worldwide, about 40 million people live with HIV, in Germany around 100,000. Without treatment, the virus weakens the immune system, especially CD4 cells, which can lead to AIDS and life-threatening complications. Early therapies now enable a normal life expectancy, but the effect in late-diagnosed patients, so-called “late presenters” with less than 350 CD4 cells per microliter, was previously unclear. This group accounts for about half of those infected and has a worse prognosis.

Effective and safe, even with late diagnosis: MHH study examines two antiretroviral drugs in people with advanced HIV disease. | Source: Karin Kaiser | Copyright: Karin Kaiser/MHH
Effective and safe, even with late diagnosis: MHH study examines two antiretroviral drugs in people with advanced HIV disease. | Source: Karin Kaiser | Copyright: Karin Kaiser/MHH

The LAPTOP study investigated two first-line antiretroviral drugs: an integrase inhibitor and a reinforced protease inhibitor. Both prevent virus replication in different ways, either by blocking the virus’s incorporation enzyme or by stopping the formation of important viral proteins. Around 450 newly diagnosed adults with advanced disease were randomized to compare efficacy, immune system recovery and side effects.

The results show that the integrase inhibitor suppressed the viral load more effectively and caused fewer side effects than the protease inhibitor. Even at extremely low CD4 levels below 50 per microliter, the drug proved to be reliable. The study therefore recommends the integrase inhibitor as the preferred first-line therapy for this patient population, which provides an important basis for future treatment guidelines.

Original Paper:

Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry, randomised, open-label, non-inferiority trial – The Lancet Infectious Diseases


Editor: X-Press Journalistenbüro GbR

Gender Notice. The personal designations used in this text always refer equally to female, male and diverse persons. Double/triple naming and gendered designations are used for better readability. ected.

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