Better generic ART for low and middle income countries: dolutegravir at US $44 a year

Simon Collins, HIV i-Base

On 30 November 2015, three new agreements were announced that should increase access to better and more affordable generic HIV drugs, including new fixed dose combinations (FDCs). [1]

The agreements were announced in a joint press statement from the Clinton Health Access Initiative (CHAI), UNAIDS, and UNITAID, and are dependent on regulatory approval and/or World Health Organization (WHO) pre-qualification.

The three compounds are:

  1. Dolutegravir as a single drug and in an FDC with tenofovir DF and 3TC. The target price of US$ 44 per year for dolutegravir would be comparable to current generic efavirenz-based ART.
  2. An FDC of TDF/lamivudine/efavirenz 400 mg (TLE400). Fixed dose combination using lower dose of efavirenz based on data from ENCORE 1 study.
  3. Heat stable darunavir/ritonavir (DRV/r).

WHO now recommends DTG as an alternate first-line therapy in those intolerant of efavirenz. Unlike US, UK and European guidelines, the WHO guidelines do not recommend dolutegravir as preferred first-line treatment due to limited data to for women who are or wish to become pregnant or for people on treatment for tuberculosis.

The press release notes that the launch price agreement for dolutegravir was made possible in part by the leadership of the Government of Kenya, which agreed to incorporate dolutegravir into national treatment guidelines as soon as regulatory approval is received.

Table 1. Plans for new generic formulations announced in November 2015
Compound Company Cost per year (US$) Filing date Comment
dolutegravir (DTG) and dolutegravir/TDF/3TC FDC Aurobindo $44

Not given

May 2015

Q3 2016

Price is comparable to current first-line efavirenz based combinations and significantly lower than current second-line ART.
TDF/3TC/EFV 400 mg FDC (TLE400) Mylan $99 Q1 2016 The cost is 9% lower that FDCs using EFV 600 mg.
Heat staple DRV/r Janssen/Hetero Not stated Q3 2016 Darunavir is the preferred boosted PI in high-income countries, based on once-daily dosing and reduced risk of side effects.


UNAIDS, CHAI and UNITAID. Joint press announcement. Three new agreements announced with the potential to expand access to innovative HIV treatment in low- and middle-income coun‚ĀĄtries. (30 November 2015).

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