Monoterapia con inhibidores de la proteasa potenciados en pacientes infectados por el VIH: resultados de un estudio en la “vida real”

espanolIntroduccion. La monoterapia con inhibidores de la proteasa (IP) potenciados (IP/r) podria ofrecer eficacia antiviral, disminuyendo interacciones medicamentosas, toxicidad y costes. El objetivo de este estudio fue determinar la eficacia de la monoterapia con darunavir/ritonavir (DRV/r) y lopinavir/ritonavir (LPV/r) en un escenario de “vida real”. Metodos. Se analizaron retrospectivamente todos los pacientes infectados por VIH tratados con DRV/r o LPV/r en monoterapia. Se incluyeron los que antes de iniciar esta estrategia tuvieran carga viral indetectable en dos controles consecutivos, sin trastornos neurocognitivos, ni coinfeccion con el virus de la hepatitis B. Resultados. Se incluyeron 60 pacientes. La mediana (IQR) de seguimiento fue de 66 semanas (33-118). La proporcion de fallos virologicos (IC95%) fue del 6,3% (1,7-20,2) y del 25,0% (12,7-43,4) en pacientes tratados con DRV/r y LPV/r, respectivamente (p= 0,0424). La proporcion de exitos terapeuticos (IC95%) fue del 90,6% (80,5-100) en el grupo de DRV/r y del 60,7% (42,6-78,8) en el de LPV/r (p=0,0063). No se detectaron mutaciones de resistencia a IP. Seis pacientes con dislipemia normalizaron los niveles. La mediana de reduccion del coste terapeutico mensual fue de 410 (IQR 242-416) euros/paciente. Conclusion. La monoterapia con IP/r es una estrategia efectiva en pacientes evaluados en un escenario de “vida real”. Este estudio demuestra diferencias a favor de DRV/r en termi-nos de exito terapeutico, aunque estos resultados deben ser confirmados en estudios prospectivos. Si bien este trabajo no fue disenado para evaluar perfil metabolico ni costes, tambien se ha observado un impacto positivo de la monoterapia en ambos terminos. EnglishBackground. Boosted protease inhibitor monotherapy may offer antiviral efficacy while reducing drug interactions, costs and toxicity. The aim of this study was to assess the efficacy of darunavir/ritonavir (DRV/r) and lopinavir/ritonavir (LPV/r) monotherapy in a real life setting. Methods. A retrospective analysis of all HIV infected patients, who had initiated DRV/r or LPV/r monotherapy, was performed. Patients whose HIV viral load had remained undetectable for at least two consecutive follow-up visits and who had no neurocognitive disorder or hepatitis B co-infection, were included. Results. Sixty patients were included. The median (IQR) time to follow-up was 66 (33-118) weeks. The proportions (CI95%) of patients with virological failure were 6.3% (1.7- 20.2) and 25.0% (12.7-43.4), respectively, in the DRV/r and LPV/r groups (p= 0.0424). The proportions (CI95%) of patients with therapeutic success were 90.6% (80.5-100) in the DRV/r group and 60.7% (42.6-78.8) in the LPV/r group (p=0.0063). No protease inhibitor mutations were detected. During the follow-up, 6 patients with dyslipidemia normalized their lipid values. The median monthly cost was 410 (IQR 242-416) euros per person lower for the monotherapy than for the combined antiretroviral therapy. Conclusions. Boosted protease inhibitor monotherapy was effective in a real life setting. This study showed differences in favour of DRV/r as compared with LPV/r in terms of therapeutic success; however prospective studies are needed to confirm these results. Finally, although this study was not specifically designed to detect benefits in terms of costs and lipid profile, it shows evidence of a positive impact of monotherapy in these fields.