Botulinum Toxin Type A Reconstituted with Lidocaine: A Report of 1000 Consecutive Cases

(1) Background: There is an increasing demand for a reversal of the aging process and, nowadays, more patients are seeking minimally invasive methods instead of surgery to meet this goal. The purpose of this paper is to evaluate the predictability of the off-label aesthetic use of botulinum toxin type A (BoNTA) reconstituted with lidocaine. (2) Methods: One thousand treatments, between January 2010 and January 2020, with BoNTA reconstituted with lidocaine for the rejuvenation of the upper third of the face, were performed and retrospectively evaluated. (3) Results: A few seconds after the BoNTA injections, the effect of muscle paralysis was seen in all cases; this allowed providing an optimal symmetric result with no need for a touch-up procedure at the control after three weeks. A burning sensation during the injections was claimed by almost all patients. Major complications were not registered. No touch-up procedures were required. (4) Conclusions: The results of this study show how the reconstitution of BoNTA with lidocaine may avoid imperfect results after the injections; the immediate feedback on the extent of paralysis to be expected from the chemodenervation action of BoNTA allows the physician to have immediate control of the final result

PROGETTO E-PROs: COSTRUZIONE DI UNA PIATTAFORMA DIGITALE PER LA GESTIONE DI STRUMENTI CENTRATI SUL PAZIENTE NELLA PRATICA CLINICA (The E-PROs Project: creation of a digital platform to manage patient-oriented tools in clinical practice).

The need to use PROs in both research and clinical practice is now widely shared. The PROs (Patient-Reported Outcomes) allow a complete and more reliable assessment of the health status of a patient through information provided by the patient himself and not detectable through clinical examinations. In clinical practice, PROs can play a central role in improving the management of chronic or disabling conditions. The application of PROs in clinical practice, however, seems to be complex, given the need to guarantee the patient adequate levels of comfort to correctly use the PROs tools (questionnaires). The E-PROs Project is a pilot study aiming to fill these gaps through the digital technology. A web platform was therefore created. By using common devices (smartphones, tablets, PC) in total privacy, patients were able to complete the "ISS-HIV-Symptoms-Scale", a PROs tool selected to test the website platform

No evidence of autoimmune disorders in antiretroviral-experienced HIV-1-infected individuals after long-term treatment with raltegravir

Background: The HIV integrase inhibitor raltegravir (RAL) can exacerbate autoimmune diseasesin genetically predisposed mice. To evaluate whether this may occur in clinical practice, weclinically monitored HIV positive patients treated with RAL and measured a panel ofautoantibodies (auto-Abs) during the first year of RAL treatment.Methods: This was a longitudinal study in 109 antiretroviral-experienced patients who started aRAL-based regimen and were followed up for more than two years. Forty-five of them were testedat baseline (before starting RAL) and after 12 months for the presence of the following auto-Abs:anti-nuclear antibodies (ANA), anti-double-stranded (ds)DNA, anti-smooth-muscle antibodies(ASMA), anti-thyreoglobulin (anti-TG) and anti-thyroid peroxidase (anti-TPO) antibodies, anticardiolipin(anti-CL) IgG and IgM, anti-nuclear extractable antigens (ENA) including anti-SMRNP antigen, anti–Ro (SSA) antigen and anti-La (SSB) antigen.Results: A low rate of clinically relevant autoimmune diseases was observed at study entry (3/109,2.8%, 95%CI = 0.004 – 0.059). No exacerbations were observed during follow-up. During thesecond year of RAL-based therapy a previously healthy patient developed psoriasis. At baseline17/45 (37.8%) patients tested for the presence of auto-Abs were positive. Most subjects (13) werepositive for anti-CL. After 12 months of RAL exposure 9/45 subjects were positive ( 20%, p =0063). A positive correlation was found between HIV-1 RNA and anti-CL antibody concentration(p = 0.010).Conclusions: According to these results, RAL does not promote antibody-mediated immunedisorders at least in the mid-term. A prolonged follow up and an extension of autoAbs’ panel arerecommended to support these results

Validation of a self-reported HIV symptoms list: the ISS-HIV symptoms scale.

Background: To describe the development and the psychometric properties of the Istituto Superiore di Sanità-HIV symptoms scale (lSS-HIV symptoms scale). Methods: The ISS-HIV symptom scale was developed by an Italian working team including researchers, physicians and people living with HIV. The development process went through the following steps: (1) review of HIV/AIDS literature; (2) focus group; (3) pre-test analysis; (4) scale validation. Results: The 22 symptoms of HIV-ISS symptoms scale were clustered in five factors: pain/general discomfort (7 items); depression/anxiety (4 items); emotional reaction/psychological distress (5 items); gastrointestinal discomfort (4 items); sexual discomfort (2 items). The internal consistence reliability was for all factors within the minimum accepted standard of 0.70. Conclusions: The results of this study provide a preliminary evidence of the reliability and validity of the ISS-HIV symptoms scale. In the new era where HIV infection has been transformed into a chronic diseases and patients are experiencing a complex range of symptoms, the ISS-HIV symptoms scale may represent an useful tool for a comprehensive symptom assessment with the advantage of being easy to fill out by patients and potentially attractive to physicians mainly because it is easy to understand and requires short time to interpret the results

Rate and determinants of residual viremia in multidrug-experienced patients successfully treated with raltegravir-based regimens

none15noResidual HIV viremia, defined by low levels of plasma HIV RNA with enhanced-sensitivity assays, may persist even in the presence of successful antiretroviral therapy, but little is known about its determinants. Our objective was to evaluate the rate and determinants of residual viremia in patients who show stable undetectable plasma HIV-1 RNA with conventional assays. Forty-four multidrug-experienced patients with undetectable levels of HIV RNA for at least 2 years under raltegravir-based regimens were evaluated. An ultrasensitive (2.5 copies/ml) real-time PCR method was used to quantify plasma HIV RNA. After 12 months of salvage treatment, 48.3% of the patients had residual viremia between 2.5 and 37 copies/ml. The proportion of patients with plasma HIV RNA below 2.5 copies/ml decreased from 51.7% at 12 months to 30.8% at 24 months. The presence of residual viremia was not associated with levels of viremia before starting raltegravir. Considering CD4 counts, hepatitis B or C virus (HBV or HCV) coinfection, or other demographic characteristics, for the time interval between HIV diagnosis and initiation of antiretroviral therapy, patients with a longer interval (>1 year) were significant less likely to have RNA levels below 2.5 copies/ml at 12 months compared to patients who started therapy within 1 year of HIV diagnosis (28.6% vs. 73.3%, p=0.027). Half of the patients showing undetectable HIV viremia with conventional assays had low-level viremia with ultrasensitive assays, with no predictive role of viroimmunological status at the start of the regimen. The potential influence of the interval between HIV diagnosis and initiation of treatment should be confirmed in subjects with a known date of seroconversion.Baroncelli, Silvia; Pirillo, Maria Franca; Galluzzo, Clementina Maria; Antoni, Anna Degli; Ladisa, Nicoletta; Francisci, Daniela; D'Ettorre, Gabriella; Segala, Daniela; Vivarelli, Angela; Sozio, Federica; Cirioni, Oscar; Weimer, Liliana Elena; Fragola, Vincenzo; Parruti, Giustino; Floridia, MarcoBaroncelli, Silvia; Pirillo, Maria Franca; Galluzzo, Clementina Maria; Antoni, Anna Degli; Ladisa, Nicoletta; Francisci, Daniela; D'Ettorre, Gabriella; Segala, Daniela; Vivarelli, Angela; Sozio, Federica; Cirioni, Oscar; Weimer, Liliana Elena; Fragola, Vincenzo; Parruti, Giustino; Floridia, Marc

J Acquir Immune Defic Syndr

Background: There are few data comparing patient-reported outcomes (PROs) in randomized trials of initial antiretroviral therapy. We present results from a substudy of the NEAT001/ ANRS143 trial. Methods: The randomized trial compared first-line DRV/r 800/100 mg once daily plus RAL 400 mg twice daily and DRV/r plus TDF/ FTC 245/200 mg once daily. Changes in PROs were assessed with 3 questionnaires: EuroQoL 5 domains (EQ-5D), Center for Epidemiologic Studies Depression (CES-D) scale, and HIV Treatment Satisfaction Questionnaire. Major depressive disorder (MDD) was defined as CES-D $16. General estimating equations were used to model change over 96 weeks in PROs from baseline. Results: Of the 805 participants, 797 (99$ 0.05 for all domains over follow-up). There was no significant difference between groups on CES-D [difference of 20.1 (95% CI: 21.3 to 1.1); P = 0.9], or MDD during follow-up, adjusted for baseline MDD (odds ratio = 0.98, 95% CI: 0.82 to 1.18; P = 0.9). RAL + DRV/r group had lower level of convenience (P = 0.03) and fitted less well into patients' lifestyle (P = 0.007) than the TDF/FTC + DRV/r regimen, and was associated with lower treatment satisfaction [median score: 53 RAL + DRV/r vs 55 TDF/FTC + DRV/r (P = 0.001)]. Conclusion: PROs improved after starting antiretroviral therapy, with no statistically significant difference between groups. The lower satisfaction with RAL + DRV/r may be explained by twicedaily administration