Generic dolutegravir submitted to FDA for tentative approval

Simon Collins, HIV i-Base

On 26 May 2015, the most recently approved, and possible most advanced, HIV medicine was submitted to the US FDA for tentative approval as a generic formulation. [1]

This is significant move towards greater equity of access to modern treatment between high and low income countries.

Dolutegravir is a once-daily low millgram (50 mg) dose integrase inhibitor that does not require PK boosting and that can be taken with or without food, and that has a high genetic barrier to drug resistance. These are all properties that argue for the global need for dolutegravir in all countries.

After FDA approval in 2012 [2] dolutegravir was rapidly included as preferred as a first-line option in US treatment guidelines. [3] This was based on superiority or non-inferiority data to other commonly used first and second line drugs.

FDA filing for the generic version has come less than two years after US approval, and well within the existing patent life. This was achieved by a collaboration between ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative (CHAI).

Tentative approval will enable generic dolutegravir to be prescribed in generic-accessible low- and middle-income countries (LMIC), including under PEPFAR funded projects.

Dolutegravir was approved by the EMA in January 2014 (and by the NHS in the UK in January 2015).


During the regulatory and approval process for dolutegravir, based on the PK profile, the need for better first and second line drugs in LMIC and the complex pricing for new drugs, we suggested in HTB that rapid access to dolutegravir in LMIC had the potential to drive better standards compared to high-income countries, if access was prioritised as an advocacy issue for global health.

This is an example for how global health care can work for the benefit of all citizens and is only possible because of the previous work since 2000 to establish access to HIV treatment as a global right.

This remarkable progress with dolutegravir access is also largely due to CHAI deciding to prioritise access to medicines with the highest global need. Previously CHAI responded to community demands tor effective and affordable second-line therapy by achieving the lowest cost access to second-line therapy by negotiating bulk discounts for atazanavir/ritonavir.


  1. ViiV press statement. ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV. (26 May 2015).
  2. FDA press statement. FDA approves new drug to treat HIV infection. (12 August 2013).
  3. US DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
  4. ViiV Healthcare press statement. ViiV Healthcare’s new HIV medicine Tivicay (dolutegravir) is approved in Europe. (21 January 2014).
  5. NHS England. Clinical Commissioning Policy: Dolutegravir for treatment of HIV- 1 in adults and adolescents. Reference: NHS England B06/P/a. January 2015.

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