Two new, simplified treatment options are at least as effective as current approaches, according to results from a world’s first international clinical trial of second-line HIV treatment led by UNSW Sydney’s Kirby Institute and presented today today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
Second-line treatment is the name given to the range of treatment options available to a person for whom the first anti-HIV treatment offered does not work. Worldwide, this represents approximately 10% of people living with HIV.
This discovery of global significance means that for the more than 3 million people living with HIV worldwide for whom standard first-line HIV treatment is not working, there is now evidence to support a range of treatment options. treatment, which is crucial to enable optimal access to treatment, especially in low- and middle-income countries.
“Recommendations for second-line therapy are generally effective in achieving viral suppression; however, some involve drug resistance testing which can be a strain on health systems. Also, many treatments require multiple pills and can have side effects,” says Professor Gail Matthews of the Kirby Institute, who presented the results at CROI. “Understanding the pros and cons of different treatment approaches is important to guide decision-making. »
The D2The EFT study was designed to compare a standard approach for second-line treatment of HIV – ritonavir-boosted darunavir + 2-nucleoside backbone – to two alternative second-line treatment regimens: dolutegravir (DTG) with boosted darunavir by ritonavir (DRV/R) and dolutegravir with fixed tenofovir and lamivudine or emtricitabine (TDF/XTC).
The new treatment options have been shown to be at least as good as standard of care for achieving viral suppression, but have potential additional benefits in terms of cost, tolerability and simplification.
This finding of non-inferiority has important implications for HIV care worldwide. Adopting either of these simplified treatments could mean administering fewer pills, avoiding the need for specialized resistance testing and reducing drug costs. In low- and middle-income countries where healthcare systems and supply chains can be fragile, these simplified treatment options can optimize treatment access, while delivering equally high levels of viral suppression.
Professor Matthew Law, Kirby Institute
D2EFT recruited 831 patients from 14 countries. Patients were randomized to one of three arms.
“The Kirby Institute has an extensive clinical network and participating sites have done tremendous work to ensure this trial continues to meet the challenges of the COVID-19 pandemic. The results of our D2The EFT trials are particularly robust because the study was conducted in an incredibly diverse group of countries. We believe the results are relevant and important internationally, but especially in low- and middle-income countries,” says Professor Law.
Meg Doherty, director of WHO’s global programs on HIV, hepatitis and sexually transmitted infections in Geneva, welcomed the results of the D2EFT study. “The results further reinforce the current WHO recommendation to use dolutegravir as the preferred antiretroviral option, while providing new insights into simplifying second-line HIV treatment in low- and middle-income countries,” said she declared.
The D2The EFT study is primarily funded by the global health agency Unitaid, with support from the National Institutes of Health (NIH), ViiV Healthcare, the Australian National Health and Medical Research Council (NHMRC) and Janssen.
Stakeholder Quotes
“For the D.2EFT study, social value is at the heart of the logic. With a particularly vulnerable study population, the involvement of participating communities was crucial to the success of the study. This was done through a Community Advisory Board (CAB) structure, which allowed for many voices to be represented. Incorporating community voices in this way ensures that the community and scientists work together to generate community-applicable knowledge. »
– Leo Perelis, Global President, D2EFT Community Advisory Board.
“In global health, we need to build strong defenses at all stages of care. Unitaid co-funded the D2EFT study to advance simple and tolerable HIV treatment alternatives for people for whom our first line of defense has failed. This research has not only included diverse populations across countries and continents to ensure that solutions work for everyone, but it also strengthens efforts to confront drug resistance in the fight against HIV. »
– Dr Philippe Duneton, Executive Director of Unitaid
