The World Health Organization (WHO) has issued new antiretroviral treatment guidelines recommending dolutegravir-based treatment as the preferred first-line treatment option for all adults, adolescents and children, including women and adolescent girls who have access to consistent and reliable contraception.
The decision highlights the huge gap in access to reliable contraception and its lack of integration into HIV programmes, especially in sub-Saharan Africa, said speakers at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam, where access to sexual and reproductive health services is emerging as a major challenge facing HIV treatment programmes.
The guidelines were released on the opening day of the conference, where women living with HIV from sub-Saharan Africa demonstrated to demand that they, not ministries of health, should decide whether they receive dolutegravir. The protest came in response to recent decisions in some countries to withhold dolutegravir from women of childbearing potential due to safety concerns over the use of the drug in the early stages of pregnancy.
Dolutegravir, a highly effective HIV integrase inhibitor with a high barrier to the development of drug resistance, was first recommended in WHO guidelines as an alternative regimen in 2016. Since then, a major price reduction along with further data on the use of dolutegravir alongside tuberculosis medication, side-effects and the risk of IRIS in people starting dolutegravir have increased confidence that the drug can be used safely in resource-limited settings.
In 2017, WHO recommended that countries with high pre-treatment levels of resistance to nevirapine or efavirenz should move rapidly to introduce dolutegravir-based treatment as the preferred first-line regimen.
The President’s Emergency Plan for AIDS Relief (PEPFAR) has also recommended that national treatment programmes supported by PEPFAR should shift rapidly to dolutegravir-based treatment.
Some of the world’s largest antiretroviral treatment programmes have already switched to recommending first-line treatment with dolutegravir, tenofovir and lamivudine, including Brazil, Nigeria, South Africa, Botswana, Zambia and Uganda. Most other high-burden countries in southern and eastern Africa have either begun pilot introductions or plan to do so soon.
This rapid shift was challenged in May by the issuing of a safety warning of an elevated risk of neural tube defects in infants born to women who were taking dolutegravir at the time of conception. The data came from a national safety surveillance study in Botswana (the Tsepamo study) and showed that neural tube defects occurred more frequently in infants born to women taking dolutegravir at the time of conception when compared to infants exposed to other antiretrovirals (although the incidence was below 1%). Findings from this study will be presented in a separate session later today.
WHO and other regulatory agencies advised in May that until more information became available, dolutegravir should be prescribed only if women have consistent and reliable contraception. The guidelines released this week stress that women who do not want to become pregnant can receive dolutegravir together with consistent and reliable contraception.