Most importantly, among treatment-naive patients, most of these cohorts are only descriptive, single-arm studies that do not compare the effectiveness of dolutegravir/lamivudine with other drug regimens. Most of them involve a limited number of subjects and/or a single centre: this limits the power of the study to compare its effectiveness with other ARTs and the analysis of certain subgroups of interest, such as those with low CD4 cell counts or high plasma viral loads (VLs). 7–10 However, these studies have several shortcomings, especially regarding treatment-naive patients. Several cohort studies have evaluated the use of dolutegravir/lamivudine in clinical practice worldwide, confirming the results of the previous clinical trials. Therefore, it is important that the information from clinical trials of ART is complemented by real-life studies. 3, 4Ĭlinical trials usually involve selected subjects that are not fully representative of the general population and take place in settings with frequent and standardized follow-up procedures that might not reflect day-to-day clinical practice. DT as a combination of dolutegravir (DTG) and lamivudine (3TC) has shown high efficacy and good safety and tolerability in clinical trials, both in treatment-naive 1, 2 and treatment-experienced patients who are virologically suppressed. During the first 48 weeks after dolutegravir/lamivudine initiation, 1.0% of treatment-naive and 1.5% of treatment-experienced subjects discontinued dolutegravir/lamivudine due to an adverse event.Īlthough for many years the use of three antiretroviral drugs has been the standard treatment of HIV infection, two-drug regimens (dual therapy, DT) have been increasingly used with the aim of simplifying the treatment and minimizing toxicity. The probability of achieving VS with dolutegravir/lamivudine was not significantly different compared with any other regimen at 24 or 48 weeks, with the exception of a lower chance of achieving VS at 24 weeks for DRV/COBI/FTC/TAF (adjusted OR: 0.47 95% CI: 0.30–0.74) compared with dolutegravir/lamivudine.įor the analysis of treatment-experienced virally suppressed subjects we included 1456 individuals who switched to dolutegravir/lamivudine, among whom 97.4% and 95.5% maintained VS at 24 and 48 weeks, respectively. At 24 and 48 weeks after starting dolutegravir/lamivudine, 91.4% and 93.8% of the subjects, respectively, achieved VS. We included 2160 treatment-naive subjects, among whom 401 (18.6%) started with dolutegravir/lamivudine.
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