Cost-effectiveness analysis of efavirenz versus ainuovirine in people living with HIV initiating first-line combination antiretroviral therapy.

BACKGROUND: Ainuovirine (ANV), a new non-nucleoside reverse transcriptase inhibitor, has been shown to have comparable effectiveness to efavirenz (EFV) with fewer adverse events. However, evidence on the cost-effectiveness of replacing EFV-based regimens with ANV-based regimens remains limited, particularly within the context of China's National Free Antiretroviral Treatment Programme. OBJECTIVE: This study aimed to evaluate the cost-effectiveness of ANV-based versus EFV-based regimens among people living with HIV (PLWH) in China. METHODS: Decision tree-Markov models were developed to compare EFV-based and ANV-based regimens over a 15-year time horizon from a societal perspective. Model inputs, including treatment costs and adverse event risks, were mainly obtained from a multicentre Chinese cohort and field survey data. Cost-effectiveness was assessed separately for treatment-naïve and treatment-experienced populations and at the overall programme level. Outcomes included costs, quality-adjusted life-years (QALYs), adverse events and incremental cost-effectiveness ratios (ICERs). One-way, probabilistic and scenario sensitivity analyses were conducted to assess parameter and structural uncertainty. RESULTS: Compared with the EFV-based regimen, ANV-based regimen was associated with a marked reduction in cumulative adverse events, while producing small per-person QALY gains of 0.006-0.011 at modestly higher costs across the modelled populations. ANV-based regimens generated slightly higher QALYs at modestly higher costs across all modelled populations. The ICERs were $10 030.41/QALY in treatment-naïve individuals, $3881.06/QALY in treatment-experienced individuals and $5146.18/QALY at the overall programme level, all below the prespecified willingness-to-pay threshold of three times China's 2019 per-capita gross domestic product ($30 793.15/QALY). Sensitivity analyses showed that the results were robust, with ANV and EFV medication costs being the most influential parameters. If the half-year cost of ANV medication decreased below $361.39, the ANV-based regimen would become the dominant strategy, providing greater health benefits at lower overall costs. CONCLUSION: Within the context of China's National Free Antiretroviral Treatment Programme, ANV-based regimens were cost-effective compared with EFV-based regimens among PLWH, with reduced adverse events and modest QALY gains at acceptable incremental costs. These findings support consideration of ANV-based regimens as an alternative option in future procurement and price negotiation decisions.