Global uptake of heat stable lopinavir/ritonavir underscores the need for improved protease inhibitor formulations for second-line antiretroviral therapy in low- and middle-income countries

Background: Second line antiretroviral therapy (ART) is characterized by protease inhibitors (PIs). With the exception of nelfinavir, all PIs required boosted ritonavir, which needs refrigeration. The first heat stable co-formulation, lopinavir with ritonavir (LPV/r) was introduced in 2006. Market analyses on uptake of heat stable LPV/r and the PI market have not been conducted but are needed to document demand for more acceptable formulations in low- and middle-income countries.

Methods: We analyzed 2,126 donor funded PI purchases from 2002 to 2009, reported to the World Health Organization Global Price Reporting Mechanism and the Global Fund Price Quality Report.

Results: Between 2003 and 2005 indinavir and nelfinavir accounted for the majority of PI market (47 to 72%), while refrigerated LPV/r accounted for 6 to 12%. Upon introduction in 2006, heat stable LPV/r accounted for 22% of the PI market, increasing to 60%, 85%, and 95% in 2007, 2008 and 2009, respectively. Within the heat stable LPV/r market, Abbott represented 100% of market volume in 2006, but by 2009 represented 74% of the market while Matrix representing 25%.

Abbott's tiered price ($500/person/year) for African and least developed countries was much lower than generic heat-stable LPV/r prices from 2007-2008. By 2009, generic heat-stable LPV/r dropped to $476/person/year, below Abbott's pricing. Soon thereafter in 2010, Abbott's tiered price dropped to $440/person/year.

Conclusions: The uptake of heat stable LPV/r underscores the need for heat-stable co-formulations to facilitate second-line ART scale-up. Increasing competition from generic manufacturers is needed to promote further price reduction.