Antiretroviral treatment French guidelines 2013: economics influencing science.

Guidelines for the preferred choice of initial combination antiretroviral therapy in those living with HIV are provided by several national and international committees. Following the recent presentation of the 2013 French guidelines on antiretroviral therapy, there has been a debate regarding whether and/or how economics should influence guideline decisions and to what extent this should counterbalance valid scientific evidence. We discuss here the reasons for the unique nature of some of the proposals made by the French guidelines panel. Indeed, some recommendations are debatable. In the new French guidelines, economic considerations significantly influence and, in some instances, take precedence over the scientific evidence, leading to guidelines that are significantly different from those of other national and international committees.

Mean cost of a first combination antiretroviral therapy in HIV-infected patients in France, and determinants of expensive drugs prescription.

To estimate the cost of the first combination antiretroviral drug therapy (cART) in HIV-infected patients and to determine factors associated with expensive prescriptions, 1698 patients starting cART between September 2002 and September 2007 were selected from the Dat'AIDS cohort. A multivariate linear regression model was used to assess associations between the cost of first cART and patient characteristics, clinical centre and cART adequacy. At cART initiation, the median age was 39 years, median CD4 count was 223 cells/mm(3), median viral load (VL) was 5.2 log copies/mL and 18.3% presented with AIDS. cART was concordant with the French guidelines in 88.7%. The mean cost of cART varied from €26.69/day/person in 2002-2003 to €32.23 in 2006-2007 (P < 0.0001), cost was associated with previous AIDS diagnosis (€31.83/day/person) versus (29.49; P < 0.0001), baseline VL > 5 log copies/mL (€30.99/day/person) versus (28.33; P < 0.0001) and centre. cART regimen not concordant with guidelines were more expensive (€38.31/day/person) versus (29.07; P < 0.0001). After adjusting for the year of initiation, the previous AIDS diagnosis, VL and recommended cART regimen, differences were still found between centres (from €27.81/day/person) to (33.12; P < 0.0001). Cost should be considered when choosing a first cART regimen, especially when considering clinically equivalent regimens.

Long-term assessment of nevirapine-containing highly active antiretroviral therapy in antiretroviral-naive HIV-infected patients: 3-year follow-up of the VIRGO study.

OBJECTIVES: Data on the durability of antiretroviral regimens over a 3-year period have only rarely been reported. The aim of this study was to evaluate the long-term efficacy and safety of one or two daily doses of nevirapine (NVP), in combination with stavudine (d4T) and didanosine (ddI), in HIV-infected patients. METHODS: This study was a follow-up of the VIR (amune) Grand Ouest (VIRGO) study, a 12-month open-label trial to assess the safety and immunovirological activity of NVP-d4T-ddI combination therapy in antiretroviral-naive HIV-1-infected adults with baseline CD4 counts > or =200 cells/microL and plasma viral loads > or =5000 HIV-1 RNA copies/mL. Of the 100 patients included in the study, the 67 patients remaining on the initial triple therapy at the end of the study (1 year) were offered an extra 24 months of follow-up. RESULTS: Of the 60 patients who extended follow-up, 46 were still being treated with d4T-ddI-NVP at month 36; 91% (39/43) had a plasma viral load <500 copies/mL (data were missing for three patients). CD4 cell counts increased over 36 months. Safety and tolerance were good with no unexpected long-term toxicity. CONCLUSION: After 3 years of treatment with NVP-d4T-ddI, nearly half of the patients were still receiving the initial antiretroviral therapy with a sustained and durable immunovirological benefit. Long-term toxicity was mainly related to the nucleoside reverse transcriptase inhibitor components of the regimen.

Sustained bacteremia in 26 patients with a permanent endocardial pacemaker: assessment of wire removal.

We reviewed the data on 26 patients with permanent endocardial pacemakers who had 28 episodes of bacteremia to determine whether removal of the wire is required. Patients recovered completely from the first episode in seven of 20 cases of staphylococcal bacteremia and in six of six cases of nonstaphylococcal bacteremia (P = .015). Definitive cure was not achieved during the first episode in seven cases of staphylococcal bacteremia related to the pacing system when the wire was not withdrawn; however, cure was achieved in five of six cases when the whole pacemaker was removed (P < .01). The duration of treatment was longer for the patients from whom the wire was not removed during the first episode (P < .01). Whether cases of staphylococcal bacteremia were related to the pacing system or not, the rate of recovery of the responsible microorganism from the wires was similar for both groups of patients (six [82%] of seven and three [75%] of four, respectively). Nonstaphylococcal bacteremia was unrelated to the pacing system in five of six cases; these patients were all cured without removal of the wire.