Search results

This study evaluated the 12‐month retention rate of third agents in HAART (highly active anti‐retroviral therapy) regimens in routine clinical practice in a Canadian HIV clinic. This is a descriptive retrospective database analysis of HIV‐positive patients naïve to antiretroviral therapy (ART). The study included male and female HIV patients≥18 years of age at HAART initiation date, seen in routine consultation at the Maple Leaf Medical Clinic (MLMC), Toronto, Ontario, Canada. Data were extracted from the MLMC database for the period of September 1st, 2003 to August 31st, 2010 for patients who commenced a protease inhibitor (PI), a non‐nucleoside reverse‐transcriptase inhibitor (NNRTI), or an integrase inhibitor (II) ‐based regimen in combination with two nucleoside reverse transcriptase inhibitors (NRTI). Demographic and baseline disease characteristics were extracted and include age, gender, disease duration, baseline HIV‐1 RNA count, CD4 cell count, and hepatitis B and C co‐infection status at baseline. A total of 722 patients were included in the analysis. The primary outcome of the study was the proportion of HIV patients remaining on their initial third agent (PI, NNRTI, or II) at one year post‐treatment initiation. For therapies used by more than 10% of patients (efavirenz [EFV]=315, atazanavir [ATV]=104, lopinavir [LPV]=162, as other agents were used but in limited numbers), the percentage of patients still on the initial third agents at one year was 77%, 64% and 62%, respectively. In addition, viral load (VL) was less than 50 copies/mL in 95% of EFV, 79% of ATV and 76% of LPV patients at one year. The rate of discontinuation at 12 months from EFV, ATV, and LPV due to efficacy (i.e. lack of virologic suppression) or safety (i.e. adverse events) were 15.56%, 19.23%, and 19.75% respectively. In a clinical practice setting, the majority of patients treated with HAART regimens were maintained on therapy at one year and were able to suppress their viral load consistently. Of those reported here, EFV resulted in the best retention rate and viral suppression overall.

Etravirine (ETV) has been approved for use in treatment‐experienced patients based on results of the Duet clinical trials [1]. Less experience exists with ETV in earlier stages of treatment. ETV has a favorable genetic barrier, lipid profile, and little associated CNS toxicity. These characteristics make ETV attractive as a switch strategy for simplification and/or management of side effects. A retrospective chart review was conducted at a large urban HIV clinic in Toronto. All patients who were switched to ETV plus 2 nucleosides and whose viral load (VL) was <200 copies/ml at the time of switch were included. Maintenance of viral suppression, CD4 and lipid changes at 24 weeks and reason for switch to ETV are reported. Seventy‐three patients (67 male) were identified. Mean age was 46±10 and mean duration of HIV infection was 11.7±7.4 years. Switches were from efavirenz=29, atazanavir=23, lopinavir=16, other=5. Duration of prior regimen was long; median 195 weeks. CNS and GI intolerance were the most common reasons for switches. At the time of analysis, 63 patients had reached week 24. Three patients had discontinued ETV prior to week 24, 3 LTF/U, 4 had <24 weeks follow‐up. 92% (67/73) maintained VL suppression (ITT); failures were 6 patients who stopped/lost‐to‐follow‐up prior to week 24. On treatment, CD4 increased and lipid decreased changes as seen below. All patients who switched due to CNS side effects had subjective improvement.










Baseline
Change from baseline to week 24 (OT, n=63)
P value




CD4 (cells/mm3)
632±269
+49±137
<0.01


Total cholesterol (mmol/L)
4.76±1.11
−0.57±0.77
<0.01


HDL (mmol/L)
1.20±0.36
−0.05±0.21
0.06


LDL (mmol/L)
2.71±1086
−0.40±0.73
<0.01


Triglycerides (mmol/L)
2.06±1.86
−0.55±1.76
0.02




Switch to ETV plus 2 nucleosides maintained viral suppression, improved lipid profiles and improved side effect profile in this selected group of patients. 48 week f/u will be presented.

We conducted preregistered replications of 28 classic and contemporary published findings, with protocols that were peer reviewed in advance, to examine variation in effect magnitudes across samples and settings. Each protocol was administered to approximately half of 125 samples that comprised 15,305 participants from 36 countries and territories. Using the conventional criterion of statistical significance (p <.05), we found that 15 (54%) of the replications provided evidence of a statistically significant effect in the same direction as the original finding. With a strict significance criterion (p <.0001), 14 (50%) of the replications still provided such evidence, a reflection of the extremely highpowered design. Seven (25%) of the replications yielded effect sizes larger than the original ones, and 21 (75%) yielded effect sizes smaller than the original ones. The median comparable Cohen's ds were 0.60 for the original findings and 0.15 for the replications. The effect sizes were small (< 0.20) in 16 of the replications (57%), and 9 effects (32%) were in the direction opposite the direction of the original effect. Across settings, the Q statistic indicated significant heterogeneity in 11 (39%) of the replication effects, and most of those were among the findings with the largest overall effect sizes; only 1 effect that was near zero in the aggregate showed significant heterogeneity according to this measure. Only 1 effect had a tau value greater than.20, an indication of moderate heterogeneity. Eight others had tau values near or slightly above.10, an indication of slight heterogeneity. Moderation tests indicated that very little heterogeneity was attributable to the order in which the tasks were performed or whether the tasks were administered in lab versus online. Exploratory comparisons revealed little heterogeneity between Western, educated, industrialized, rich, and democratic (WEIRD) cultures and less WEIRD cultures (i.e., cultures with relatively high and low WEIRDness scores, respectively). Cumulatively, variability in the observed effect sizes was attributable more to the effect being studied than to the sample or setting in which it was studied.