Background and importance Recently, the EMA and AEMPS have approved the use of doravirine (DOR) a non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class. At present, the therapeutic arsenal available in Spain presents various options within each class.
Aim and objectives To position DOR within the antiretroviral therapies (ART) already available in the hospital´s pharmacotherapeutic guidelines and asses its incorporation.
Material and methods A bibliographic search was conducted on DOR’s positioning in the main national and international guidelines with the following terms: HIV, adults and guidelines; GESIDA (Spain); DHHS (American) and EACS (European). Possible advantages with respect to the ART already available in hospital were analysed. In addition, an economic evaluation was conducted comparing with available ART and the potential patients who would benefit from its use. The official list price was used with the deduction described in the Royal Decree Law 8/2010 as well as 4% VAT.
Results Gesida guidelines (July 2020) recommended the combination DOR+FTC/TAF or DOR/3TC/TDF (not yet marketed in Spain) as an alternative to the preferred regimens (C-I), but never as the initial therapy. On the other hand, the DHHS guidelines (June 2020) recommended DOR as the initial regimens in certain clinical situations. EACS guidelines (2019 update) recommended it as an initial regimen in combination with two NRTIs or as DOR/3TC/TDF.
The main advantages of DOR are: efficacy in high viral loads (rilpivirine (RVP) is not effective), lower potential for drug interactions, lack of food restrictions, fewer adverse effects on the CNS compared with efavirenz (EFV) and a neutral lipid profile (avoiding dyslipidaemia induced by EFV or boosted protease inhibitors.
The number of patients undergoing treatment with NNRTIs in our hospital was 322 (n=1894 total active HIV positive patients). The potential percentage of use was about 17% of the total. DOR+FTC/TAF or DOR+FTC/TDF represented a cost of 851.55€ and 642.90€/patient/month, respectively. RVP/FTC/TAF, EFV/FTC/TDF or DRV/COBI/FTC/TAF would cost 673.57, 262.58 or 857.51€/patient/month, respectively.
Conclusion and relevance DOR would be beneficial in those patients with CNS disorders due to EFV and high viral load (>100 000 copies) or in polymedicated patients because of the lower profile of interactions. In the remaining cases, there are alternatives already available in the hospital (following recommendations of the GESIDA guidelines).
Conflict of interest No conflict of interest
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