Effectiveness and safety of simplification from tenofovir-lamivudine (TDF-3TC) to tenofovir-emtricitabine (TDF-FTC) co-formulation (Truvada) in virologically suppressed HIV-infected patients on HAART.

The objective was to evaluate the effectiveness and safety of simplification from tenofovir-lamivudine (TDF-3TC) to Truvada (TVD) in virologically suppressed HIV patients. We carried out an open-label, multicentre, non-controlled study of HIV patients on a stable regimen including TDF-3TC who switched from TDF-3TC to TVD. Viral load responses at 24 and 48 weeks were evaluated. Changes in the calculated glomerular filtration rates (cGFR; Cockcroft-Gault equation) were analysed at baseline and at 24 and 48 weeks. Patients with drug-related nephrotoxicity (cGFR < 60 mL/min at 48 weeks or interruption of TVD because of renal toxicity) were analysed in detail. Two hundred and ninety-five patients with a mean time on TDF-3TC of 19.9 months (range 8.8-29.8) were enrolled. The third drug was a non-nucleoside reverse transcriptase inhibitor, which was administered to 187 patients (76.4% efavirenz) and a protease inhibitor was administered to 108 (43.5% lopinavir/ritonavir). At 48 weeks, 85.7% of the patients were still taking the same regimen, all with an undetectable viral load. The cGFR (mL/min) decreased from baseline (111 [89-130]) to 48 weeks (105 [84-121]); p < 0.0001. The percentage of patients with a cGFR <60 mL/min at 48 weeks was 3.5. Six patients ceased TVD because of drug-related nephrotoxicity. The only factors associated with nephrotoxicity were age, baseline weight and cGFR. Simplification from TDF-3TC to TVD was associated with a decrease in cGFR, with a low prevalence of nephrotoxicity at 48 weeks.

Simplicity and efficacy of a once-daily antiretroviral regimen with didanosine, lamivudine, and efavirenz in naïve patients: the VESD study.

PURPOSE: Our aim was to analyze the efficacy and safety of didanosine-lamivudine-efavirenz in a cohort of HIV patients starting antiretroviral therapy between January and September 2003. METHOD: We undertook a prospective, open-label, observational, multicenter study. RESULTS: 163 patients were enrolled. Over a 48-week period, plasma HIV RNA levels declined sharply, with a median decrease at the end of the observation time of >4.62 log copies/mL. The proportion of patients achieving a plasma HIV RNA level below 50 copies/mL was 62.9% (intention-to-treat analysis) at the end of the study period. The mean CD4 cell count increased steadily over time by 199 cells/microL. Antiviral efficacy was similar in patients with a baseline HIV RNA level above or below 100,000 copies/mL. Overall, 57 (34.1%) patients interrupted therapy; 9 due to lack of treatment response, 18 due to adverse side-effects, and 30 patients lost to follow-up or who withdrew their consent. Adherence was very high (90%-95%) and quality of life was good or very good in 69%. CONCLUSION: The once-daily combination of didanosine-lamivudine-efavirenz resulted in sustained viral suppression and was well-accepted by patients under real-life conditions, even immunosuppressed patients and those with a high viral load. Associated adverse events and virological failures were few.

Ancianos con infección por el VIH institucionalizados: análisis de dos casos / Elderly institutionalised individuals with HIV infection: analysis of two cases

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Continuous gastric drip versus intravenous fluids in low birthweight infants.

UNLABELLED: This multicentre randomized study compared a continuous gastric drip (CGD) with intravenous (i.v.) fluid administration. Healthy newborns with birthweight from 1501 to 2000 g whose physician ordered i.v. fluids were randomized before the 2nd hour of life to CGD or i.v. fluids. The major outcome variable was the need for an i.v. line in the CGD group. Serum glucose was measured at 30 min, 1 h and every 6 h thereafter. Serum sodium and potassium were measured at least once during the first 72 h of life. Enteral feedings, feeding intolerance, number of venous lines and i.v. line-related complications were recorded until the interruption of CGD or the i.v. line. Twenty-nine infants were randomized to each group. The two groups were comparable in terms of birthweight and gestational age. Ten percent (3/29) of the infants randomized to the CGD group required i.v. fluids and 90% of them received electrolytes and glucose through an orogastric tube. The incidence of hypoglycaemia, hyponatraemia and episodes of feeding intolerance did not differ between the groups. CONCLUSION: Fluid administration by CGD reduces the need for i.v. lines without increasing the risk of complications.