SS software for Windows Version 15.0 was used for statistical analysis. Categorical variables are described by number and continuous variables, where not otherwise specified, were evaluated as median and IQR. The time to lossof therapeutic response was estimated using Barasertib AZD1152-HQPA the Kaplan Meier method. The Student,s t test was used to compare related quantitative variables. A last observation carried forward approach was used for missing CD4 T cell and lipid data. All statistical tests were two tailed. Ethics The study was approved by the Commission of Medical Ethics of Hospital Vall d,Hebron. Our institutions have an active programme for HIV infected patients that provides care to most of the population in our reference areas. All HIV infected patients included gave written informed consent to use the information available in the databases.
No other consent was required due to the observational design of the study. Results Patients and baseline characteristics Baseline characteristics of the 60 patients included in this study are shown in Table 1. All patients had a long history of HIV infection and had been on antiretroviral treatment for a median of 13 years, they had BMS-387032 CDK inhibitor received a median of four highly active antiretroviral therapy regimens and eight different drugs, and had failed a median of four regimens. The median plasma viral load at baseline was 3.04 log10 HIV 1 RNA copies/mL, and 80%Patients were followed for a median time of 16 months. By ITT analysis, the cumulative percentage of patients remaining free of therapeutic failure at the end of follow up was 86.7%.
The corresponding data were 96.6% at week 24, 90.1% at week 48 and 79.8% at VX-770 week 96. By OT analysis, the percentage of patients with therapeutic response was 98.2% at week 24, 93.9% at week 48 and 88.7% at week 96. True OT virological failure was observed in four patients. One of them had low grade virological failure with persistent viral load. This patient received treatment with ritonavir boosted darunavir plus partially active etravirine. The other three patients with poor treatment adherence had viral load.10000 copies/mL, and two of these were lost to follow up after confirmed virological failure. Two additional patients with single viral rebound attained viral suppression without changing antiretroviral treatment. Regarding the immunological response, at week 48 of follow up there was a significant mean increase of 83.
6 cells/mm3 in CD4 T cell counts. Safety and tolerability Overall, five patients prematurely discontinued treatment, of these, two were lost to follow up and three discontinued due to intolerance or side effects. Of the latter, one virological failure had gastrointestinal intolerance to etravirine, another had a rash related to etravirine, the last was a haemophiliac who experienced bruising that worsened following the introduction of darunavir. No patient interrupted treatment due to liver toxicity or any laboratory related adverse event. There were no differences in fasting blood lipids after 48 weeks of treatment, with a mean decrease of 6.5 mg/dL in total cholesterol levels and a mean increase of 36.9 mg/dL in triglycerides. Discussion In this study, a dual therapy rescue regimen containing PI/r was highly effective and well tolerated in treatment experienced