The Treatment Action Campaign (TAC) welcomes the approval by the US Food and Drug Administration of the antiretroviral medicine dolutegravir. This is a new integrase inhibitor (brand name Tivicay) that could potentially become a vital drug in the global struggle against HIV. TAC calls on all parties involved to ensure widespread availability of Dolutegravir in South Africa and across the developing world.

• Dolutegravir was as good or better in the studies that led to approval than the comparison combinations, including Atripla (a brand name combination equivalent to the most widely used first line regimen in the South African public sector).
• It is effective at reducing viral load and fewer side effects were reported compared to many existing antiretroviral drugs (ARVs).
• The low milligram dose (50 mg) makes it ideal to co-formulate in Fixed Dose Combinations (FDCs).
• It is taken once-daily for most people and can be taken with or without food.

Dolutegravir has been approved for treatment naive patients with the potential to replace efavirenz (EFV) in first-line regimens. It has also been approved for treatment experienced patients in either second-line (where the price undercuts existing drugs) or third-line regimens. It is dosed at 50 mg once-daily or twice daily depending on previous resistance. For people with extensive drug resistance it may have a lower risk of drug resistance than raltegravir (RAL) which is currently used to treat third-line patients in South Africa.

The low dosage means dolutegravir has the potential to be produced at a low cost by generic manufacturers. Estimates suggest prices as low as R300 per patient per year could be achieved.

Ultimately the uptake of dolutegravir globally depends on the cost of the drug. In order to be optimal a treatment regimen must be affordable and widely available to people across the world.

• TAC urges ViiV Healthcare, the manufacturer, to rapidly register dolutegravir in South Africa.
• TAC calls on the Medicines Control Council (MCC) to evaluate the drug without delay.
• ViiV must not block access to this life-saving HIV drug through limiting generic production.
• If barriers to access remain the South African government must use flexibilities in international trade law to ensure dolutegravir can be produced or imported at an affordable price.