31 October 2018 | Press release

Dolutegravir, an alternative first-line HIV treatment for low and middle-income countries

Two years after its launch, NAMSAL (New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries), by the French Agency for Research on AIDS and Viral Hepatitis (ANRS), is yielding its first results. Conducted in Yaoundé (Cameroon), the study aims to compare the efficacy of two first-line treatments for HIV infection in more than 600 participants. The results of the trial, coordinated by Dr Charles Kouanfack (Yaoundé Central Hospital, Faculty of Medicine and Pharmaceutiques Sciences of Dschang University) and Pr Éric Delaporte (TransVIHMI, Montpellier University, Research and Development Institute (IRD) and French National Institute of Health and Medical Research (INSERM)), show 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.


The latest World Health Organization (WHO) recommendations published in July 2018, advocate first-line treatment of HIV infection using dolutegravir[1] (DTG) as an alternative to treatment with efavirenz 400 mg (EFV400)[2].

Until now, no clinical trial data have been collected to directly compare 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.

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 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% of the DTG participants and 69% 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 fact that dolutegravir is not inferior to efavirenz 400 has been demonstrated.

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.

According to Professor Éric Delaporte: “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.


Information briefings on the study findings will be organized for representatives of communities of people living with HIV and civil society. Please contact Unitaid for more information at mascheronisa@unitaid.who.int

_____________

[1] With a note of caution on the use of DTG in the periconception phase and for women and teenage girls of childbearing age, considering the possible risk of malformation of the neural tube when DTG is used during the first three months of pregnancy.

[2] EFV 400 is better tolerated than EFV 600, which is normally prescribed, and it is also available in fixed-dose combination tablets.

Sources:
Dolutegravir- versus an efavirenz 400mg-based regimen for the initial treatment of HIV-infected patients in Cameroon: 48-week efficacy results of the NAMSAL ANRS 12313 trial        
Amandine Cournil1, Charles Kouanfack2,3, Sabrina Eymard-Duvernay1, Serra Lem3, Mireille Mpoudi-Ngole4, Pierrette Omgba5, Serge Tchokonte2, Ginette Edoul Mbesse6, Eitel Mpoudi-Ngole4, Alexandra Calmy7, Eric Delaporte1,8, for the NAMSAL study group 1. TransVIHMI, Montpellier University, IRD, INSERM, Montpellier, France, 2. Central Hospital, Yaoundé, Cameroon, 3. ANRS, Yaoundé, Cameroon, 4. Military Hospital, Yaoundé, Cameroon, 5.  Cité Verte Hospital, Yaoundé, Cameroon, 6. PreVIHMI International Joint Laboratory, IRD, CREMER, Yaoundé, Cameroon, 7. Geneva University Hospitals, Geneva, Switzerland, 8. University Teaching Hospital, Montpellier, France

 HIVDrugTherapy Conference, Glasgow

Abstract available here: https://doi.org/10.1002/jia2.25187

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