HTB

Generic dolutegravir-based FDCs at US $75 a year for low- and middle-income countries

Polly Clayden, HIV i-Base

A new pricing agreement has been announced that will speed up access to generic, dolutegravir-based fixed dose combinations (FDCs).

This will enable use to treat HIV in low- and middle-income countries (LMICs) at an annual cost per person of around US $75. [1]

This announcement was made on 21 September 2017 at UNGA by the governments of South Africa and Kenya with UNAIDS, the Clinton Health Access Initiative (CHAI), the Bill & Melinda Gates Foundation, Unitaid, DFID, PEPFAR, USAID, and the Global Fund, in collaboration with Mylan Laboratories Limited and Aurobindo Pharma.

The new products combine tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) and were developed by Mylan and Aurobindo under licensing agreements from ViiV Healthcare, the originator of DTG. Both generic manufacturers received tentative approval from the US FDA for TLD in August of this year. [2]

The agreements, which set ceiling prices for TLD, apply to public sector purchasers and will offer substantial reductions compared with the price of efavirenz-based FDCs (around US $100 per person per year) [3]. This could lead to savings of up to US $900 million over the next six years in South Africa. Across the 92 countries covered under ViiV’s dolutegravir licensing agreement, six-year savings have been estimated at US $1 billion.

COMMENT

2017 is proving to be a banner year for ART optimisation.

Further price reductions are anticipated in the not too distant future, with the arrival of new FDCs that will replace tenofovir disoproxil fumarate with the much lower dose tenofovir alafenamide (TAF).

Meanwhile several studies are underway to fill the evidence gaps associated with these regimens so they can be universally recommended in LMICs – including for pregnant women and people coinfected with TB.

References

  1. WHO press release: New high-quality antiretroviral therapy to be launched in South Africa, Kenya and over 90 low- and middle-income countries at reduced price. 21 September 2017.
    http://www.who.int/hiv/mediacentre/news/high-quality-arv-reduced-price/en
  2. US FDA. Approved and tentatively approved antiretrovirals in association with the President’s Emergency Plan. (Numbers 197 and 198). 2/18 August 2017.
    https://www.fda.gov/internationalprograms/pepfar/ucm119231.htm
  3. 2016 CHAI ARV reference price list. 14 November 2016.

https://clintonhealthaccess.org/content/uploads/2016/11/2016-CHAI-ARV-Reference-Price-List_FINAL.pdf

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