Аңдатпа
Sir, We previously reported our experience in nine HIV-infected patients on dolutegravir monotherapy, naive to HAART and with a zenith HIV-RNA <100 000 copies/mL.1 We now report the results of an extended follow-up in 20 antiretroviral-naive HIV-1-infected patients with a zenith HIV-RNA <100 000 copies/mL who started dolutegravir monotherapy after refusing NRTIs and were followed at the Infectious Diseases Outpatient Department of G.B. Rossi Hospital in Verona, Italy. All the patients were HIV monoinfected, with a mean age of 43 years (range 28–76), and gave written informed consent to the use of dolutegravir as the only antiretroviral drug. Pretreatment characteristics of the patients, HIV-RNA level and number of CD4 cells at baseline, HIV-RNA level 4 weeks after starting treatment and at last visit, number of CD4 cells at last visit and duration of dolutegravir monotherapy are indicated in Table 1. No patients had baseline HIV resistance mutations for NRTIs, NNRTIs, PIs or integrase strand transfer inhibitors. Total cholesterol, LDL/HDL cholesterol and triglyceride levels before starting dolutegravir and at last visit are shown in Table 2. After a few days, one patient developed an enanthema that led to dolutegravir discontinuation. In the other 19 patients the mean duration of effective dolutegravir monotherapy was 13.3 months (range 3–21); 18 achieved a viral load <20 copies/mL at the last visit and 1 had a viral blip of 145 copies/mL. One patient (no. 9) developed a myocardial ischaemic attack. The mean increase in CD4 cell count was 266 cells/mm3 (P < 0.01). There were no significant differences between mean values of total cholesterol (168.4 versus 187.9 mg/dL), LDL cholesterol (106.38 versus 113.8 mg/dL) or triglycerides (91.6 versus 113.4 mg/dL) before starting treatment and at last visit in the 19 patients. HDL cholesterol mildly increased (from 45.8 to 50.7 mg/dL). Baseline characteristics of patients, HIV-RNA level (zenith), number of CD4 cells (nadir), HIV-RNA level after 4 weeks of dolutegravir and at last visit, number of CD4 cells at last visit and months on dolutegravir monotherapy F, female; M, male. Blood samples were collected from HIV-1-seropositive patients by venipuncture. All plasmas were extracted and quantified by the COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0 (Roche, Mannheim, Germany), following the manufacturer’s instructions. The amount of HIV-1 RNA is shown as the number of copies/mL of plasma. The lower quantitative detection limit is 20 copies/mL. Baseline characteristics of patients, HIV-RNA level (zenith), number of CD4 cells (nadir), HIV-RNA level after 4 weeks of dolutegravir and at last visit, number of CD4 cells at last visit and months on dolutegravir monotherapy F, female; M, male. Blood samples were collected from HIV-1-seropositive patients by venipuncture. All plasmas were extracted and quantified by the COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0 (Roche, Mannheim, Germany), following the manufacturer’s instructions. The amount of HIV-1 RNA is shown as the number of copies/mL of plasma. The lower quantitative detection limit is 20 copies/mL. Serum levels of total cholesterol, LDL/HDL cholesterol and triglycerides before starting dolutegravir and at last visit n.v., normal value. Serum levels of total cholesterol, LDL/HDL cholesterol and triglycerides before starting dolutegravir and at last visit n.v., normal value. The treatment of HIV infection continues to be based on the combination of three antiretroviral drugs. In antiretroviral-naive patients, PI monotherapy is inferior to standard antiretroviral regimens,2 and dolutegravir in association with two nucleosides is superior to efavirenz and darunavir.3,4 A pilot study in 20 treatment-naive patients has recently shown the virological efficacy of a combination of dolutegravir and lamivudine;5 16 patients had a baseline viral load <100 000 copies/mL, while 4 had a baseline viral load >100 000 copies/mL and a mean HIV-RNA level of 24 128 copies/mL. At week 48, one patient had a virological failure. In our study at baseline the mean HIV-RNA level was 38 360 copies/mL and no patients had a viral load >100 000 copies/mL; one patient had a viral load of 145 copies/mL at week 28. The results of our study suggest the feasibility of dolutegravir monotherapy in patients with a viral load <100 000 copies/mL. Even though lamivudine is generally well tolerated, it may lead to the development of mitochondrial toxicity,6 so its avoidance could prevent this potential side effect. Dolutegravir monotherapy should be further explored to preserve future antiretroviral drug options, while reducing side effects and healthcare costs. This study was carried out as part of our routine work. None to declare. M. L. has contributed to the clinical research, to following patients, to collecting data and to writing the manuscript. S. N., E. L., G. C. and F. R. have contributed to the clinical research, to following patients and to collecting data. D. G. and E. D. have contributed to the clinical research and to collecting data. E. C. has contributed to the clinical research. S. V. has contributed to the clinical research and to writing the manuscript.