Abstract
Objectives: Triple therapy with a 2-NRTI backbone is the standard of care approach for HIV treatment. The introduction of emtricitabine/tenofovir alafenamide (FTC/TAF) will alter the HIV drugs market in Italy. The study's aim was to analyse the effects of FTC/TAF introduction and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) disinvestment, with a Health Technology Assessment (HTA) methodology. Methods: The HTA, considering the 9 EUnetHTA (European Network for Health Technology Assessment) Core Model dimensions, involved 18 Italian Infectious Disease Department clinicians. The assessment compared the 2-NRTI backbones available in Italy; FTC/TAF, FTC/TDF and abacavir/lamivudine (ABC/3TC). Clinician perceptions were collected using validated questionnaires (a 7 level Likert scale, from -3 to +3), and economic modelling (Budget Impact Analysis) was performed. Differences among the groups were studied using ANOVA test. Results: Results from questionnaires showed that FTC/TAF ensures a higher percentage of virological and immunological control compared to FTC/TDF and ABC/3TC (1.36 vs 0.89 and 0.68 respectively; p-value: 0.023). FTC/TAF also presents a better safety profile compared to both FTC/TDF and ABC/3TC (0.93 vs -0.09 and 0.14 respectively; p-value: 0.04). FTC/TAF decreases the burden of adverse events management (0.85 vs 0.10 [FTC/TDF] and 0.26 [ABC/3TC], p-value: 0.016). From an organisational perspective, FTC/TAF could simplify the overall management of drug complications for hospitals, both in the short term (0.60 vs -0.13 [FTC/TDF] and 0.01 [ABC/3TC], p-value<0.001) and in the long term (0.65 vs -0.18 [FTC/TDF] and 0.03 [ABC/3TC], p-value<0.001). The economic modelling revealed a 6% cost saving for the NHS with FTC/TAF introduction and FTC/TDF disinvestment. Conclusions: The introduction of FTC/TAF was found to deliver improvements in efficacy, with a greater chance of virological control, and safety compared with the older 2-NRTI backbones, FTC/TDF and ABC/3TC. A FTC/TDF disinvestment strategy could be cost saving for the Italian NHS, suggesting that FTC/TAF is a dominant alternative.