Demystifying Dolutegravir based antiretroviral drug regimens

ZIMBABWE recently joined other nations to adopt the new HIV treatment regimens that contain Dolutegravir (DTG).  The complete transition process for Zimbabwe however, will not take less than 10 months to be fully implemented considering that the country has over a million people on first line HIV medicines.

By Michael Gwarisa and Dr. Simbarashe Mabaya

Countries  adopt normative guidance by the World Health Organization (WHO) which is based on rigorous review and analysis of scientific evidence. Based on this review WHO develops recommendations which make up the next guidelines. Countries subsequently adopt these guidelines to suit their unique contexts.

The recent move by Zimbabwe to adopt DTG based regimens has raised questions amongst People Living with HIV (PLHIV) and other stakeholders regarding the safety and the reasoning behind the need for transition.

Here is what Catherine Murombedzi an HIV Activist openly living with HIV had to say about the DTG transition.

With DTG used as a third line drug in Zimbabwe, are we not pushing parameters too far. If it fails, then what combination of treatment on first line lie if DTG fails for the third line client, what will be the option? Nurses working in the grassroots do not even know, yet roll over is May, why do we leave people behind, what is the plan with regards to information dissemination at grassroots level?”

To respond to this and other burning questions people might have regarding the safety and the need to transition to the new medicines HealthTimes Editor, Michael Gwarisa spoke with WHO National Professional Officer for HIV, Dr Simbarashe Mabaya to unpack and demystify the myths surround DTG and its adoption for the purposes if creating informed health decisions amongst PLHIV.

What is DTG?

DTG belongs to a class of ARV medicines called Integrase inhibitors. It is taken once daily as a pill combined with Tenofovir and Lamivudine as an effective first-line HIV treatment fixed dose combination commonly called TLD. Tenofovir and Lamivudine have been in use in the country for some years now.

How different are DTG based regimens different from other ARVs?”

The medicine that we have been using Tenofovir/Lamivudine/Efavirenz (TLE) is both safe and effective. However, TLD has been shown to be very effective, well tolerated by patients and has fewer interactions with other commonly used medications. In addition, TLD fights better against resistance by the HIV virus.

Why do we keep changing medicines?

Recommendations for medicines are based on findings of research. Throughout the world researchers are working to find safer and more effective medicines for HIV. When research shows that a new medicine has better qualities than the ones currently used it becomes necessary to transition to the new medicines. Other factors are considered such as the feasibility of offering the treatment at a large scale and cost of the treatment. The guidelines developed by WHO always ensure that access to services is fair and equitable giving priority for treatment to those most in need while promoting an environment that is free of stigma and discrimination

We have heard that DTG can cause women to give birth to deformed children, is that true?

Ongoing research in Botswana has identified a potential safety issue with dolutegravir (DTG) indicating that women who became pregnant while taking DTG may have an increased risk of giving birth to child with a deformation called Neural Tube Defect (NTD) when compared to other medicines. However, studies are still going on in other countries and WHO will provide more information as it is made available. WHO has taken this risk seriously and has therefore recommended that all women of child bearing age, who do not intend to fall pregnant can receive DTG together with consistent and reliable  family planning methods while on treatment.

Can women use DTG

Women of childbearing potential who intend to become pregnant or who are not otherwise using or accessing effective contraception can receive DTG based regimens if they have been informed of the potential increase in the risk of neural tube defects. This is an important opportunity to strengthen the collaboration between HIV and sexual and reproductive health services.

What alternatives are there for women of childbearing age

An EFV-based regimen is a safe and effective first-line regimen recommended for use and can be used among women of childbearing potential during the period of potential risk for developing neural tube defects (at conception and up to the end of first trimester). It is therefore important that health workers provide information and options to enable women to make informed choices.

What are Neural Tube Defects (NTDs).

The neural tube is the foundation of the spinal cord, brain and the bone and tissues that surround it. Neural tube defects occur when the neural tube fails to completely form; this formation takes place between 0 and 28 days after conception. Neural tube defects may be related to folate deficiency, other medications or family history. WHO recommends that women take daily supplements of folic acid before conception and during pregnancy to help prevent neural tube defects, but it is It is not clear whether taking folic acid while taking DTG will reduce the risk of neural tube defects.

Can the medicine be used by children?

Dolutegravir can be used in combination with other HIV medicines in children who weigh more than 20 Kilograms. DTG is of particular benefit to adolescents given their challenges with adherence, side effects of EFV and failure of treatment involving all 3 classes of ARVs.

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