“ADVANCE Study” – Study launched to test new and safer HIV drugs

Johannesburg, 16 January 2017 - Wits Reproductive Health and HIV Institute (Wits RHI) and their partners are excited to announce the launch today of a study, ADVANCE, to evaluate a new antiretroviral drug combination for the treatment of HIV. The ADVANCE study is funded by the U.S. Agency for International Development and UNITAID through OPTIMIZE, a global partnership working to accelerate access to simpler, safer and more affordable HIV treatment.

ADVANCE is designed to generate evidence to replace the current standard of care for first-line HIV treatment with a fixed-dose, dolutegravir (DTG) and tenofovir alafenamide (TAF) based regimen. DTG and TAF have demonstrated increased robustness and safety, in addition to better patient tolerability and reduced costs. A switch to a DTG/TAF-based regimen could enable South Africa to treat all people living with HIV in the country by 2019 with its current antiretroviral budget, suggesting the power of this regimen to enable South Africa to meet the increasing treatment demands under the “treat all” approach and to achieve the UNAIDS 90-90-90 treatment targets.

“If successful, patients will benefit from a much safer and more forgiving drug regimen in a smaller tablet,” said Professor Francois Venter, Wits RHI’s Deputy Director.

ADVANCE will enrol 1100 participants at three research sites within the Johannesburg Central Business District, and includes the evaluation of participants in vulnerable populations – adolescents, pregnant women, and people with tuberculosis and hepatitis B co-infections – establishing the benefit of these new drugs in real world conditions. Wits RHI’s research teams have engaged in preparation and training activities and will commence with screening of eligible participants at the three clinics today.

Since its inception, the ADVANCE study has been developed through extensive collaboration with a broad range of scientific partners, drug companies, donors, research affiliates and activists within the local and global arenas.

Currently South Africa has the largest antiretroviral therapy (ART) programme in the world, owing in part to recent changes in ART initiation guidelines, which call for all people diagnosed with HIV to be treated immediately. This “Test and Treat” approach was adopted by the National Department of Health in September 2016. Based on the World Health Organization’s (WHO’s) June 2016 guidelines which contain key recommendations to “treat all” people living with HIV — including children, adolescents, adults, pregnant and breastfeeding women, and people with co-infections — South Africa’s “Test and Treat” approach will steadily improve the life expectancy of patients on ART.

The expansion of treatment under “Test and Treat” also means that the ART budget must accommodate millions of people for several decades of life, as highlighted in the co-authored article cited in the South African Medical Journal, “Cutting the cost of South African antiretroviral therapy using newer, safer drugs,” published in January 2017. DTG and TAF have been hailed as potential game-changers for meeting the increased demand for HIV treatment under the new WHO guidelines given their potential for cutting costs and increasing patient benefits.