[Ip-health] TAC calls for action to ensure global access to dolutegravir

Lotti Rutter lotti.rutter at mail.tac.org.za
Wed Aug 14 05:30:54 PDT 2013



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
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. 

For all media enquiries please contact:
Lotti Rutter
 <mailto:lotti.rutter at tac.org.za> lotti.rutter at tac.org.za
+27 (0) 81 818 8493




Lotti Rutter

Senior Researcher

Policy, Communications and Research


Treatment Action Campaign

Tel: 021 422 1700

Cell: 081 818 8493

Skype: lotti.rutter

Twitter: @FixPatentLaw


 <http://www.fixthepatentlaws.org> www.fixthepatentlaws.org

 <http://www.tac.org.za> www.tac.org.za


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