NAMSAL phase III trial

The project

ANRS NAMSAL was an open-label, multicentre, randomised, non-inferiority phase III trial conducted in Cameroon over 48 weeks and extended to 192 weeks. Its objective was to evaluate the efficacy and safety of new combination therapies for the treatment of HIV-1-infected adults in the real-world setting in low-income countries.

The treatment regimens compared were dolutegravir 50 mg – an integrase inhibitor with interesting properties in terms of efficacy and, above all, resistance – versus efavirenz at low-dose, in order to reduce its side-effects while maintaining its efficacy.

A total of 613 participants were enrolled and followed for four years. The results of the primary endpoint (at week 48) demonstrated the non-inferiority of  dolutegravir to low-dose efavirenz. The results of the study support WHO recommendations to initiate antiretroviral treatment with a dolutegravir-based regimen and with a low-dose efavirenz-based regimen as an alternative.

Viral suppression was impaired in participants with a high baseline viral load; however, it was achieved much more rapidly in the dolutegravir group. Dolutegravir-based regimen was associated with a low risk of acquiring drug resistance mutations and with significant weight gain in women.

These results were confirmed at week 96.

At 192 weeks’ follow-up, the results showed long-term efficacy and safety of both regimens. However,  cardiovascular and metabolic monitoring of HIV-1-infected adults treated with dolutegravir or low-dose efavirenz should be reinforced.