Cost‐effectiveness analysis of first‐line HAART

Combining various antiretroviral agents into one single pill (STR, single‐tablet regimen) is a strategy to reduce pill burden, enhance adherence and improve efficacy of HAART. We evaluated STR from a cost‐effectiveness point of view in a large, unselected cohort of patients starting their first HAART. The incremental cost‐effectiveness analysis was carried out by means of a Markov model simulating QoL and costs for a patient, according to the given regimen, through 1‐year cycles. The considered outcome measure was quality‐adjusted life years (QALYs) and all direct health costs were computed. From January 2006 to January 2012, 793 naïve patients started their first regimen at our center and were included in the analysis. They were mostly males (74.5%) with a mean age of 39 years, a baseline mean HIV‐RNA of 200K copies/ml and a mean baseline CD4 count of 292 cells/µL. We adopted several definitions to describe STR use trying to reflect the clinical indications of single‐tablet regimens: a) any EFV‐based regimen followed by STR treatment; b) TDF + FTC + EFV followed by STR; c) any HAART regimen followed by STR; d) use since the beginning of STR. We run the analysis for each of these different STR treatment definitions and compared the results with those of two different control groups: patients receiving a PI‐based OD treatment or patients receiving a PI‐based BID treatment. For the considered definitions of STR, the mean year‐cost per patient ranged from 6,766 to 7,083€ with a mean per patient QALYs ranging from 0.955 to 0.973. In the case of OD PI‐based regimens the cost range was from 8,484 to 8,532€ and the QALYs mean varied from 0.923 to 0.925. The same values for BID PI‐based regimens were from 8,040 to 8,303€ and from 0.930 to 0.931. In all cases STR dominated (i.e. was more effective and less costly) any comparator HAART regimen. The incremental cost‐effectiveness ratio (ICER) values comparing the different STR definitions are reported in the table. STR compared to boosted PI‐based regimens either OD or BID resulted highly cost‐effective showing in any case the lowest cost and the best efficacy as measured by QALYs. The comparison of different strategies including STR use revealed that starting with an STR regimen is cost‐effective compared to simplification strategies, assuming a commonly internationally accepted threshold of 50.000€ to define cost‐effectiveness.Treatment C Mean cost per patient E Mean QALYs per patient Delta C Delta Cost Delta E Delta QALYs DC/DE ICER QALYsOD EFV ‐ based HAART? switch STR €6.766 0,960Start with STR €7.083 0.973 317 0,013 €23.770 TDF+FTC+EFV? switch STR €6.867 0,961Start with STR €7.083 0,973 216 0.012 €17.783 Any HAART? switch STR €6.947 0,955Start with STR €7.083 0,973 136 0,018 €7.555