New paper published: When to start ART in Africa - primarily guided by RCTs or patient autonomy?

Posted on Mon, Jul 15 2013 11:25:00

This Viewpoint article, published in the Journal of the International AIDS Society, is a reaction to an opinion piece in which two leading scientists from the Centers for Disease Control and Prevention (CDC) and the International Center for AIDS Care and Treatment Programs (ICAP), argued that an African RCT is urgently needed, in order to "definitively settle" the question of optimal timing of ART initiation in Africa.

We fundamentally disagree with this opinion and argue that inaction while waiting for the results of such a trial is unjustified. While we do not oppose their call for an African randomised controlled trial to better understand the health benefits and risks of earlier ART initiation, we make the case for a fundamentally different approach to ART initiation in Africa, centred on the patient's right to decide when to start ART, in consultation with his or her health care providers, and guided by all scientific evidence, including that from past, ongoing and planned implementation studies.

When to start ART in Africa, is a timely issue, especially now that the World Health Organization has launched new, consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. These stipulate that ART initiation is recommended in all individuals with a CD4+ cell count of 500 cells/mL or less (but giving priority to those with advanced clinical disease or a CD4+ cell count less than 350 cells/mL); and at any CD4+ cell count in those with active TB, Hepatitis B infection and severe chronic liver disease, in HIV-positive partners in serodiscordant couples, and in pregnant and breastfeeding women.

We welcome the new WHO guidelines and see these as a key step in the direction of offering immediate treatment to all. It will now be up to individual countries (Governments, People Living with HIV and Civil Society) to make informed decisions about when to start treatment, taking into account the entire evidence base and human rights considerations, and not primarily base decisions on RCT data or the (perceived) lack thereof.

Full citation:
When to start ART in Africa - primarily guided by RCTs or patient autonomy?
Delva W, Yvette Fleming Y, Chingandu L. J Int AIDS Soc 2013;16:18756.

Link to full paper: