Darunavir/ritonavir price now US $210 for global access
Polly Clayden, HIV i-Base
Unitaid and Clinton Health Access Initiative (CHAI) recently announced a new pricing agreement to make darunavir/ritonavir (DRV/r) available as a second-line HIV treatment in low- and middle-income countries for US$ 210 per patient, per year. 
Hetero Labs LTD’s World Health Organization (WHO) prequalified DRV/r will be available in 90 countries at a cheaper price than the most commonly-used second-line option lopinavir/ritonavir (LPV/r). Through the agreement, the price for DRV/r works out at US$ 17.50/pack (plus shipping and insurance).
The product is manufactured as 400/50 mg pills, two of which are taken as a once-daily dose of 800/100 mg DRV/r.
It will be registered widely in eligible countries using the WHO Collaborative Registration Procedure (CRP) for prequalified products. This procedure accelerates registration through information sharing between the WHO Prequalification of Medicines Programme (PQP) and national regulatory authorities.
Governments and international agencies such as PEPFAR and the Global Fund will be able to purchase DRV/r at this price.
Originator manufacturer Janssen has not enforced patents for darunavir when it is used in sub-Saharan Africa and least developed countries since 2012. But access has been thwarted by slow approval and a complex process to develop a stable, generic co-formulation and complete successful bioequivalence studies.
At present DRV/r is recommended by WHO as an alternative second-line HIV treatment.
The new generic product, plus recent findings from the NADIA trial – first shown at CROI earlier this year and now published in the NEJM [3, 4] – both support the argument to reposition DRV/r in the hierarchy of PIs.
Wider availability should lead to an upgrade to “preferred” rather than “alternative” in WHO recommendations and increased use of this PI. Although dolutegravir (DTG)-based treatment (which is still considerably cheaper than a PI) is likely to be most commonly used for people failing efavirenz-based first-line, those who receive DTG first-line will need a PI second-line.
Unitaid expects DRV/r to be introduced in countries by early 2022. But, they note that COVID-19 could affect this timeline.
CHAI is currently engaging with high-burden countries and trying to accelerate their procurement of this product. Carolyn Amole, Senior Director of the HIV access programme at CHAI, said they are “hoping there will be a loud cry for this product from the community as well!”
- Unitaid press release. Innovative agreement launches affordable, optimal second-line HIV treatment in low- and middle-income countries. 26 July 2021.
- WHO. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. 16 July 2021.
- Clayden P. Dolutegravir with recycled tenofovir and lamivudine performs well second-line: primary results from the NADIA trial. 12 March 2021.
- Paton NI et al. Dolutegravir or darunavir in combination with zidovudine or tenofovir to treat HIV.
N Engl J Med 2021; 385:330-341. 22 July 2021.
This article was first published on 12 August 2021.