NAMSAL Trial - A clinical trial to generate robust evidence on the clinical and economic characteristics of a dolutegravir-based regimen in an African setting
Challenges
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.
Solutions
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. Further data from the trial, along with other studies, informed the revision of the WHO HIV treatment guidelines in July 2019 to recommend DTG for all populations on first-line ART. It also guided the Cameroonian Ministry of Health to revise its treatment guidelines to include DTG and Efavirenz 400 as first-line protocol. Interim results were published in tandem with the ADVANCE trial results in the New England Journal of Medicine in July 2019. The trial completed 96 weeks with results published in Lancet HIV.
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 (see results);
- Efavirenz concentration levels in pregnant women and in TB co-infected patients; and the
- HIV virus’ emerging resistance to these treatments.
Due to the weight gain and hyperglycemia safety signals, the Unitaid Board approved TRIO, a pooled initiative which permits the extension of three treatment optimization studies; ADVANCE, NAMSAL, and DolPHIN-2 to reach 192-weeks observations. This allows for a longer monitoring period in addition to an opportunity to coordinate and pool data. Final analysis of TRIO data will be published in Q2 2022.
COHIVE, a COVID-19 sub-study was included in the NAMSAL trial and also in D2EFT, DolPHIN-2 and ADVANCE trials) to assess the impact of COVID-19 in people living with HIV. Results should be published in Q4 2021: https://kirby.unsw.edu.au/project/cohive-coronavirus-outcomes-hiv-evaluation-resource-limited-settings.
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.
