Relative cost-effectiveness of long-acting injectable cabotegravir versus oral pre-exposure prophylaxis in South Africa based on the HPTN 083 and HPTN 084 trials: a modelled economic evaluation and threshold analysis

Cabotegravir—Global Access to Long-Acting Pre-exposure Prophylaxis for HIV

“…High NNTB means that CAB-LA will only be a feasible alternative to TDF/FTC if prices are dramatically cut. ViiV currently claim a lowest price of $1440 per year, 16-times higher than cost-effectiveness estimates and 100-times higher than lowest possible pricing estimates (9,14). ViiV is seeking regulatory approval in several excluded countries where clinical trials were conducted, such as Brazil, spiking further ethical questions around post-trial access.…”

“…Both were stopped due to e cacy. CAB-LA has the potential to substantially reduce new HIV infections over the next 50 years if used widely, as shown by the 27% reduction in HIV incidence over 20 years in patients using CAB-LA in South Africa (9). This is promising as incidence currently matches mortality, so that the number of PLWH remains stable, sustaining the pandemic (1).…”

“…As a result, even tiered costs for branded CAB-LA would be untenable. While ViiV suggest a cost price of $1440 per year, South African cost-effectiveness and threshold analysis suggests an annual cost between $60-$119 per year would be cost-effective (9). Estimates for lowest possible pricing are around $16 per year (14).…”

Leveraging PEPFAR for HIV drug equity

“…Experience with oral PrEP shows that many people find it challenging to take a pill daily, while others are reluctant because of HIV-related stigma (4). Taking long-acting injectable cabotegravir every 2 months can help overcome many of the objections users may have (5). Another issue with oral PrEP has been that even though demonstration projects were funded and started in the years following proof of efficacy, little coordination among funding and implementing agencies dragged out the incorporation of the drugs into high-quality programs (4).…”

Control groups for HIV prevention efficacy trials: what does the future hold?

“…It will be difficult to demonstrate superiority over CAB-LA, as clinic administration minimizes the adherence challenges that appear to influence oral PrEP efficacy [27][28][29][30]. Its high cost has restricted CAB-LA adoption as standard of care [31,32], thus providing it as part of a clinical trial raises questions around poststudy access. Daily oral PrEP was the comparator in both PURPOSE-1 [33] and PURPOSE-2 [34] studies (ClinicalTrials.gov #NCT04994509 and NCT04925752, respectively) of semi-annual lenacapavir compared with oral PrEP, and the prematurely terminated Merck studies (MK-8591-022 [35] and MK-8591-024 [36]) of oral monthly islatravir (ClinicalTrials.gov #NCT04644029 and NCT04652700, respectively).…”