The NASMAL study is the first of its kind to compare in real-life conditions two treatments of HIV infection, one dolutegravir-based and the other based on efavirenz 400 mg. Until now, there has been no direct comparison of the action of these two drugs in countries with limited resources.
Coordinated by Eric Delaporte (Université de Montpellier, Inserm, IRD) and Charles Kouanfack (Hôpital Central Yaoundé, Faculté de médecine, Université de Dschang), NAMSAL(1) shows that dolutegravir is not inferior to efavirenz in real-life conditions, confirming the latest World Health Organization guidelines. The results are published today in The New England Journal of Medicine.
The latest World Health Organization (WHO) guidelines updated in December 2018 recommend first-line treatment of HIV infection based on dolutegravir2 (DTG), as an alternative to efavirenz 400 mg-based treatment (EFV 400)3. This recommendation was based on study findings showing that DTG was superior to EFV 600 in terms of both efficacy and safety. Alternatively, the safety of EFV 400 was good for an efficacy comparable to that of EFV 600. However, these results were recorded following studies in high-income countries in populations not comparable to those living in countries with limited resources. In particular, the results were recorded in women whose viral load was generally higher at the start of antiretroviral treatment and who were infected by HIV-1 strains different from those in developed countries.
NAMSAL is the first study to compare two treatments (EFV 400 and DTG) in combination with tenofovir and lamivudine in a country of limited resources. This phase 3, randomized, open study was conducted in Yaoundé in Cameroon between 2016 and 2018 in 613 people living with HIV who had never taken antiretroviral treatment. Coordinated by Eric Delaporte (Université de Montpellier, Inserm, IRD) and Charles Kouanfack (Hôpital Central Yaoundé, Faculté de médecine, Université de Dschang), the results published today not only show that DTG was not inferior to EFV 400 after 48 weeks of treatment, but also that the risk of development of resistance to treatment was lower with DTG.
That said, irrespective of the drug used, the results obtained are not as good as those recorded in higher-income countries, mainly because of the high viral load in people at initiation of treatment. This emphasizes the importance of screening to enable early treatment and the need to conduct such studies in countries with limited resources. Furthermore, the study confirms that weight gain and the risk of obesity are greater with DTG than with EFV 400.
According to Unitaid Deputy Executive Director Dr Philippe Duneton, "This trial is the first of its kind to supply comparative data on the use of dolutegravir in people living with HIV in low-income countries such as Cameroon. Unitaid values the great importance of the partnership with ARNS and WHO, because it will accelerate access to better HIV treatment."
1. New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries
2. With a note of caution regarding the use of DTG during periconception and in women and teenage girls of childbearing age, because of the potential risk of malformation of the neural tube when DTG is used during the first trimester of pregnancy.
3. EFV 400 is better tolerated than the usually precribed EFV 600 and is available in fixed-dose combination tablets.
Charles Kouanfack, Mireille Mpoudi-Etame, Pierrette Omgba Bassega, Sabrina Eymard-Duvernay, Sandrine Leroy, Sylvie Boyer, Martine Peeters, Alexandra Calmy, Eric Delaporte, Dolutegravir or Low Dose of Efavirenz- based regimen for the Initial Treatment of HIV-1 Infection « The NAMSAL study group », The New England Journal of Medicine, 24 juillet 2019.
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