Optimising the manufacture, formulation, and dose of antiretroviral drugs for more cost-efficient delivery in resource-limited settings: a consensus statement

Estimation of Intracellular Concentration of Stavudine Triphosphate in HIV-Infected Children Given a Reduced Dose of 0.5 Milligrams per Kilogram Twice Daily

“…That dose optimization process is now being revisited, the most recent example being the Evaluation of Novel Concepts in Optimization of antiRetroviral Efficacy (ENCORE) trial, which showed noninferiority of 400 mg efavirenz compared to 600 mg (36). Similar trials are under way to evaluate reduced doses of zidovudine, stavudine, tenofovir, atazanavir, darunavir, and ritonavir (37,38).…”

The evolution of three decades of antiretroviral therapy: challenges, triumphs and the promise of the future

“…The promise of HIV eradication was fuelled by the 'Berlin patient', who received an allogeneic stem cell transplantation from an HLA-matched donor homozygous for a 32 bp deletion in the CCR5 allele 6 years ago and has remained free of recrudescent HIV replication off cART [74]. The definition and quantification of HIV eradication has not been precisely Three decades of antiretroviral therapy defined; however, 5 years after cART withdrawal there has been significant waning of HIV-specific T-cell responses and no evidence of active HIV replication in this patient [75]. Experimental pharmacological strategies to bring HIV out of latency have been examined in early phase studies in humans.…”

ARVs: The Next Generation. Going Boldly Together to New Frontiers of HIV Treatment

“…While these prices are more than the manufacturing cost, they are used as a proxy for the fully loaded costs, given that the generic market is competitive with a relatively low profit margin. For hypothetical ARV combinations, illustrative manufacturing costs were estimated as follows: (1) rilpivirine oral or injectable: $15, based upon expert consultation, 6 and assuming cost of oral rilpivirine ≤ cost of injectable; (2) dolutegravir oral: $25, based upon expert consultation, 6 and assuming cost of oral dolutegravir ≤ cost of injectable; (3) cabotegravir injectable: $25, assumed to be same cost as dolutegravir injectable and given similar structure of the 2 compounds; (4) TAF: $14 assumes TAF costs 1/3 of TDF at approximately 1/10 the dose; (5) cobicistat: $90; in the absence of other data, cost assumed to be the same as another pharmacokinetic booster, ritonavir 25 ; and (6) elvitegravir (150 mg/day) and doravirine (100 mg/day), both assumed to cost $25 per year to manufacture in the absence of other data. Note that the costs for these hypothetical ARVs are solely meant to provide a sense of the degree of savings that might be possible; actual costs may be substantially higher or lower than these estimates.…”