No abstract

This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Objectives To assess the attitudes and opinions about generic antiretroviral drugs (ARVs) and single-tablet regimen (STR) de-simplification among physicians prescribing HIV treatment in the cohort of the Spanish HIV/AIDS Research Network (CoRIS). Methods An online questionnaire with 27 structured questions was sent to all physicians (n = 199) who prescribed ARVs among the 45 centres participating in the cohort. Results A total of 169 (84.9%) physicians answered the questionnaire. Only 4.1% of the physicians would never prescribe generic ARVs, but 53.3% would not prescribe them if the number of pills per day increased and 89.3% would not prescribe them if the number of doses per day increased. However, 84.0% of the physicians agreed to prescribe generic ARVs if doing so would decrease costs for the public healthcare system. The percentages of physicians stating that generic ARVs (compared with branded ones) would be associated with worse adherence, more adverse effects or more probability of virological failure, provided that the number of pills and doses per day would not change, were low: 0.6%, 7.7% and 3.6%, respectively. However, these percentages were much higher if the generic ARV entailed breaking an STR: 63.9%, 18.9% and 42.0%, respectively. Most physicians stated that they needed more information about the effectiveness and safety of generic ARVs and the price difference compared with their branded equivalents. Conclusions Although most physicians were confident about prescribing generic ARVs, the majority had strong concerns about de-simplifying STR, and they also needed more information about generic drugs.

Objectives We compared 48 week effectiveness and safety of first-line antiretroviral regimens. Methods We analysed HIV treatment-naive adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) starting the most commonly used antiretroviral regimens from 2014 to 2018. We used multivariable regression models to assess the impact of initial regimen on: (i) viral suppression (VS) (viral load <50 copies/mL); (ii) change in CD4 cell count; (iii) CD4/CD8 normalization (>0.4 and >1); (iv) CD4 percentage normalization (>29%); (v) multiple T-cell marker recovery (MTMR: CD4 > 500 cells/mm3 plus CD4 percentage >29% plus CD4/CD8 > 1); (vi) lipid, creatinine and transaminase changes; and (vii) discontinuations due to adverse events (AE). Results Among 3945 individuals analysed, the most frequently prescribed regimens were ABC/3TC/DTG (34.0%), TAF/FTC/EVG/CBT (17.2%), TDF/FTC + DTG (11.9%), TDF/FTC/EVG/CBT (11.7%), TDF/FTC/RPV (11.5%), TDF/FTC + bDRV (8.3%) and TDF/FTC + RAL (5.3%). At 48 weeks, 89.7% of individuals achieved VS with no significant differences by initial regimen. CD4 mean increase was 257.8 (249.3; 266.2) cells/mm3, and it was lower with TAF/FTC/EVG/CBT and TDF/FTC/RPV compared with ABC/3TC/DTG. CD4 percentage normalization was less likely with TAF/FTC/EVG/CBT, and MTMR was less likely with TAF/FTC/EVG/CBT and TDF/FTC + RAL. The proportion of discontinuations due to AE was higher with TDF/FTC + bDRV (9.7%), followed by TDF/FTC/EVG/CBT (9.5%) and TDF/FTC + DTG (7.9%). Compared with ABC/3TC/DTG, cholesterol and LDL mean increases were higher with TAF/FTC/EVG/CBT and lower with TDF/FTC + DTG, TDF/FTC/RPV and TDF/FTC + RAL. Higher mean increases in triglycerides were significantly associated with TAF/FTC/EVG/CBT. Regimens containing DTG showed higher creatinine increases. Conclusions The significantly greater immunological response and safety of some combinations may be useful for making decisions when initiating treatment.

BackgroundCalcinosis cutis is caused by accumulation of calcium salts in the tissues, with subcutaneous nodules, atrophy and ulceration over the affected area. The therapeutic approach is not clearly established, particularly in neonates.PurposeTo treat calcinosis cutis in a topical non-invasive way in two premature neonates and to describe their clinical evolution.Developing a standard operating procedure (SOP) for compounding a 10% sodium thiosulfate W/O topical cream.Material and methodsA systematic bibliographic search for available therapeutic options was made. An article by Pérez-Moreno et al.1 was found, describing the elaboration procedure of a 10% sodium thiosulfate W/O cream and its use in a 6-year-old child with calcinosis cutis. However, no evidence was found regarding topical treatment of calcinosis cutis in neonates.Risks and benefits of using the topical formula in premature neonates were assessed: excipients were found to be suitable and the risk of incremented absorption was considered acceptable.It was decided to reproduce the formula for its use in two cases of IV calcium extravasation (confirmed by echography and clinical signs) in two premature neonates (born at 31 and 34 weeks).Modus operandi consisted of:Dissolving 10 g of pentahydrated sodium thiosulfate in 10 mL of distilled water.Adding it to the external oil phase (a commercial cold cream (COLDBASE) was used qs 100 g).Mixing it until an homogeneous W/O emulsion was obtained.ResultsThe elaboration process was simple, and the resultant cream homogeneous and with suitable organoleptic characteristics.Clinical evolution was satisfactory in both patients, gradually reducing visible injuries, subcutaneous calcifications, induration and swelling. Both patients regained arm mobility completely.ConclusionTreatment of calcinosis cutis with topical sodium thiosulfate was safe and effective in both patients. The clinical benefit in premature patients was thereby confirmed in these cases.References and/or AcknowledgementsPérez-Moreno MA, Álvarez del Vayo-Benito C, Flores-Moreno S, et al. Calcinosis cutánea grave tratada exitosamente con una fórmula magistral tópica W/O de tiosulfato sódico al 10%. Acta Pediatr Esp 2014;72:e9-10No conflict of interest.