A clinical trial to generate robust evidence on the clinical and economic characteristics of a dolutegravir-based regimen in an African setting
More than 15 million people living with HIV have no access to treatment, around half of them in eastern and southern Africa. New antiretroviral drugs such as dolutegravir (DTG) offer improved treatments, but their suitability for resource-limited settings is unknown because they have been evaluated mainly in US and European markets.
DTG has been shown in trials to be safer, more effective and more affordable than many antiretrovirals. Because it has fewer side effects, patients are more likely to finish the treatment.
Studies suggest that switching to DTG-based regimens could enable low-and middle-income countries to expand antiretroviral therapy fast enough to reach the UN 90-90-90 targets for ending the HIV/AIDS epidemic.
“The results of this study are highly anticipated at the international level in order to evolve the treatment recommendations for better tolerated and more effective strategies.”
Professor Eric Delaporte, trial principal investigator
Progress so far
The NAMSAL/ANRS 12313 trial aims to confirm the efficacy of DTG-based first-line treatment in a low-income country (Cameroon). The trial started in July 2016, and initial results were presented at HIV Glasgow in October 2018. All participants are in the 96-week trial follow-up phase. Next results will be presented at the IAS and ICASA meetings in 2019, and 96-week results are expected in late 2019. Post-trial results will be ready near the end of 2021.
The project also includes sub-studies on:
- the cost-effectiveness of introducing DTG as a first-line HIV drug in low- and middle-income countries;
- efavirenz concentration levels in pregnant women and in TB co-infected patients; and the
- HIV virus’s emerging resistance to these treatments.
In The Lancet:
- Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon (October 2020)
- Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial (October 2020)
The impact we are seeking
The grant aims to contribute to the scale-up of improved first-line antiretroviral treatment. It will strengthen the evidence base for the clinical and economic benefits of a DTG-based first-line regimen in Africa. This regimen could directly impact millions of people living with HIV if it were recommended as a first-line treatment. It could also generate significant financial savings, as it is more affordable compared with current treatment options.