Dolutegravir, an alternative first-line HIV treatment for low and middle-income countries
The latest World Health Organization (WHO) recommendations published in July 2018 advocate first-line treatment of HIV infection using dolutegravir (DTG) as an alternative to treatment with efavirenz at 400 mg (EFV400). Until now, no clinical trial data have been collected for direct comparison of the efficacy of the two drugs in the specific context of low-income countries. The ANRS NAMSAL study has compared the effect of both DTG and EFV with 613 participants living with HIV who had not previously received ARV treatment.
Conducted in Yaoundé (Cameroon), the study shows that dolutegravir-based treatment is not inferior to treatment with efavirenz (400 mg). In the specific context of treatment for people living with HIV in southern countries, the researchers believe that first-line treatment with dolutegravir is a good alternative to efavirenz. The findings of the study, co-funded by Unitaid and ANRS, are being presented at the HIVDrugTherapy Conference in Glasgow on Wednesday, 31 October 2018.
Unitaid Deputy Executive Director Dr. Philippe Duneton says, "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 ANRS and WHO, because it will accelerate access to better HIV treatment."
The participants in the ANRS NAMSAL trial were randomly divided into two groups. The first group followed a DTG-based regimen, while the second followed a EFV400-based regimen. After 48 weeks, 74.5 percent of the DTG participants and 69 percent of the EFV400 participants presented with an HIV plasma viral load of below 50 copies per ml of blood.
This shows that DTG-based treatment is not inferior to EFV400-based treatment. The observed difference between the two treatments was not significant enough to assert the superiority of either regimen over the other. Moreover, participants showed similar tolerance to both treatments. DTG is thus considered a valid treatment option in first line in the context of treating people with HIV in low- and middle-income countries.
Professor Éric Delaporte says, "In patients presenting with a high viral load in their blood at the start of treatment, we observed persistently low viral replication rates in both prescribed treatments (DTG and EFV). Hence, it is important to continue long-term monitoring of the patients who initiated DTG treatment to confirm the absence of resistance mutations to this drug; the trial will continue until 2021."
"We welcome the results from this important research," said Dr. Gottfried Hirnschall, WHO's Director for HIV and hepatitis. "The ANRS NAMSAL study supports joint efforts being made by WHO and Unitaid to optimize HIV treatment and to identify ever better and safer treatments for people living with HIV."
The ANRS New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries (NAMSAL) trial launched in July 2016 is being conducted in Cameroon at three hospitals in Yaoundé: The Central Hospital, the Military Hospital and the Cité Verte district hospital. It will continue until 2021. It included more than 600 participants infected with HIV who had never had antiretroviral treatment. The aim was to compare the efficacy, tolerance and cost of the two first-line antiretroviral treatments, efavirenz 400 mg and dolutegravir. The trial is being promoted by ANRS and coordinated by Dr. Charles Kouanfack (Faculty of Medicine and Pharmaceutiques Sciences of Dschang University) and Pr Éric Delaporte (TransVIHMI). It is co-funded by ANRS and Unitaid.