Dolutegravir Plus Lamivudine as First-Line Regimen in a Multicenter Cohort of HIV-1-Infected Patients: Preliminary Data from Clinical Practice

Editor: The results from the ACTG 5353 trial1 and GEMINI trials2 have demonstrated the efficacy of a dual therapy with dolutegravir plus lamivudine as first-line regimen in treatment-naive HIV-positive patients. This regimen, already closely evaluated as a switch option in treatment-experienced patients, for whom it has shown a good tolerability profile and a high virological efficacy in the long term,3,4 is increasingly becoming a promising option for the treatment of a large portion of HIV-infected patients. We would like to present the preliminary data from a multicenter study on antiretroviral therapy (ART)-naive patients starting lamivudine plus dolutegravir in clinical practice. At baseline and at each follow-up visit viroimmunological markers of HIV infection, including plasma HIV-RNA level, were collected (quantitative assay, detection limit of 37 copies/mL). We evaluated the proportion of patients reaching virological suppression (defined as HIV-RNA <50 copies/mL) during follow-up time. The study was approved by each local ethics committee (promoting center protocol number: 5284/15) and all patients signed an informed consent. We enrolled 10 patients: 6 (60%) men, with a median age of 50 years (interquartile range [IQR] 30–55). At baseline, median HIV-RNA was 4.84 log10 copies/mL (IQR 4.64–4.96), whereas median CD4+ cell count was 342 cell/mm3 (IQR 301–419). Two patients presented a peak HIV-RNA >100,000 copies/mL. One patient, with a peak HIV-RNA of 55,833 copies/mL, after 3 weeks from ART initiation, achieved a HIV-RNA of 104 copies/mL, but no following virological determinations are at the moment available. The other nine patients reached 8 weeks of follow-up; among them, eight reached the virological suppression, whereas one patient, who started with a peak HIV-RNA of 102.657 copies/mL, had a HIV-RNA determination of 55 copies/mL. The seven patients who reached 24 weeks of follow-up had a HIV-RNA quantification <50 copies/mL; of them, five reached 48 weeks of follow-up and all of them had an undetectable viral load (Table 1).