Evidences on the absence of risk of sexual transmission of HIV by persons living with HIV/AIDS (PLWHA) with undetectable plasma HIV-RNA (HIV-RNA <200 copies/ml) led to the worldwide campaign "U = U" ...(undetectable = untransmittable). The purpose of this study was to evaluate the perceived accuracy of this message among PLWHA, HIV-negative people having unprotected sex (PHUS) and infectious diseases' (ID) physicians in Italy. A nationwide survey has been conducted using three different anonymous questionnaires (for ID physicians, PLWHA and PHUS). A total of 1121 participants filled the questionnaires: 397 PLWHA; 90 physicians; 634 PHUS. Awareness of U = U message has been reported in 74%, 92% and 47% of PLWHA, ID physicians and PHUS, respectively. The perception of accuracy of the U = U message among those aware was reported as high in 80.4%, 79.5% and 67.3% of PLWHA, ID physicians and PHUS, respectively. Physicians perceived that 11% of PLWHA have a high rate of perception of U = U, whereas among PLWHA, only 34% reported definitive positive messages from physicians. Discrepancies between awareness and perception of accuracy of the message U = U in PLWHA and physicians have been found, suggesting still low confidence in the community regarding the message itself.
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DOBA, IJS, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response ...to ART.
Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as switching regimen while virologically suppressed. Primary endpoint was time to treatment failure (TF): new AIDS/death or virological failure (VF) or discontinuation for toxicity/failure. Secondary endpoints were time to treatment discontinuation for toxicity (TDT) and to VF. Groups of interest were those aged >50 years, female sex, and advanced HIV disease at first ART start. Probability of the events overall and according to groups and adjusted HR for every endpoint were calculated by Kaplan-Meier curves and Cox regression models.
Nine hundred and thirty-three ART-naive and 1655 ART-experienced PWH initiated BIC/FTC/TAF. Over a median follow-up of 69.8 weeks, 89 (9.6%) PWH at their first regimen experienced TF. PWH aged >50 years had 1.83-fold (95% CI: 1.19-2.83) higher risk of TF; PWH with advanced HIV disease had 2.21-fold (95% CI: 1.53-3.82) higher risk; there were no differences in TF according to sex.Over a median follow-up of 146.3 weeks, 109 (6.6%) out of 1655 switching PWH experienced TF; no differences were found in the risk of TF, TDT and VF according to groups of interest.
Overall, BIC/FTC/TAF is well tolerated and virologically effective in the real-world scenario for ART-naive and -experienced PWH. Older ART-naive PWH and those with advanced HIV disease may respond less well as the burden of diseases might compromise treatment efficacy.
Abstract
Objectives
To compare the long-term risk of treatment failure of dolutegravir-based ART in men and women in a real-life setting.
Patients and methods
Persons living with HIV (PLWH) from the ...ICONA cohort were included if they had started dolutegravir in a two- or three-drug regimen as ART-naive or as virologically controlled ART-experienced. The primary endpoint was time to treatment failure (virological/clinical failure or dolutegravir discontinuation). Secondary endpoints were: time to dolutegravir discontinuation due to toxicity and to neuropsychiatric adverse events; and time to virological failure. Cox regression analyses focused on differences in outcomes by sex.
Results
A total of 2304 PLWH (15% women) initiated dolutegravir-based therapy from ART-naive, and 1916 (19.8% women) while experienced. After a median follow-up of 2.2 (IQR: 0.9–3.9) years in ART-naive and 2.4 (IQR: 1.1–4.3) years in experienced, the 4-year cumulative probability of treatment failure was 33% (95% CI 30.5–35.1) and 20% (95% CI 17.8–22.3), respectively. In the multivariable analyses, in ART-naive the risk of treatment failure was higher for women, but not different after excluding women discontinuing dolutegravir for pregnancy concerns. We also observed a higher risk of discontinuation for toxicity in women (ART-naives: Adjusted Hazard Ratio (AHR): 1.56%; 95% CI: 1.03–2.37; ART-experienced: AHR: 1.53%; 95% CI: 1.01–2.32), although the absolute 4-year probability was low: 7.7% (95% CI 6.5–9.2) in ART-naive and 8.3% (95% CI 6.9–9.9) in experienced.
Conclusions
In our cohort of PLWH treated with dolutegravir-based regimens and followed up for up to 4 years, we observed a low risk of treatment failure and no evidence for a difference by sex, after excluding discontinuation due to pregnancy concerns. However, we observed a higher risk of dolutegravir discontinuation for toxicity in women.
HCV infection has been hypothesized as a contributor of poor CD4+ recovery in patients living with HIV (PLWHIV). Aim of this study was to evaluate CD4+, CD8+ cells and CD4/CD8 ratio trends before and ...after HCV treatment with direct acting agents (DAA) in PLWHIV. HIV/HCV patients enrolled in ICONA and HepaICONA cohorts with HIV‐RNA≤50 copies/ml who achieved a sustained viral response after DAA treatment were studied. A linear regression model was used to investigate CD4+, CD8+ and CD4/CD8 changes 12 months before and after DAA treatment. A total of 939 HIV/HCV patients were included, 225 (24.0%) female, median age: 53 years (IQR 50–56). At DAA initiation, CD4+ T cell count was <350 cells/mm3 in 164 patients (17.5%), and 246 patients (26.2%) had liver stiffness>12.5 kPa. Trends of CD4+ and CD4/CD8 ratio were similar before and after DAA in all study populations (CD4+ change +17.6 cells/mm3 (95%CI −33.5; 69.4, p = 0.494); CD4/CD8 change 0.013 (95%CI −0.061; 0.036, p = 0.611). However, patients treated with ribavirin (RBV)‐free DAA showed a significant decrease in CD8+ cells (−204.3 cells/mm3, 95%CI −375.0;‐33.4, p = 0.019), while patients treated with RBV experienced CD8+ cell increase (+141.2 cells/mm3, 95%CI 40.3; 242.1, p = 0.006). In conclusion, HCV eradication following DAA treatment does not seem to have an impact on CD4+ T cell recovery in PLWHIV. However, a fast decline of CD8+T cells has been observed in patients treated without RBV, suggesting a favourable effect of HCV clearance on the general state of immune activation.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
Background
The aim of this study was to investigate the impact of anti-HBc (HBcAb) positivity on the progression of liver fibrosis (Fibrosis-4 score >3.25) in the Italian cohort of ...HIV-infected individuals naïve to antiretroviral treatment (ICONA).
Methods
All patients with FIB-4 <3.25 at baseline were evaluated prospectively: 6966 people with HIV (PWH) were screened and classified based on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology.
Results
Patients who were HBcAb+/HCV-/HBs antigen (HBsAg)- and HCV+/HBcAb+/HBsAg- or HBsAg+/HBcAb+/HCV- had CD4+ cell counts below the nadir and significantly higher prevalence of AIDS diagnosis at baseline than the other groups (P < .0001). A Cox regression model adjusted for age, HIV transmission mode, country of birth, and alcohol consumption showed a higher relative risk (HR) of progression to FIB-4 >3.25 in HCV+/HBcAb+/HBsAg- patients (HR, 7.2; 95% CI, 3 8–13.64).
Conclusions
HBcAb+ contributes to liver damage in HIV+/HCV+/HBcAb+/HBsAg- subjects. A careful monitoring for signs of previous HBV infection is needed in this kind of patients.
In the last few years the increasing interest for non-invasive operating techniques has allowed to reevaluate the sublinguinal varicocelectomy surgical technique for idiopathic varicocele surgical ...treatment. During the years 1998-2001, 29 patients have been operated on sub-inguinal varicocelectomy (14 patients were suffering from idiopathic varicocele of third grade, 11 of second grade, 3 of first grade, and 1 subclinical). Out of the 29 patients, only 10 were unable to procreate. All patients were operated under local anesthesia and discharged the same day (day-surgery). Owing to Authors' experience, the sublinguinal varicocelectomy by optical magnifying devices represents the "gold standard" in the idiopathic varicocele treatment because it allows to minimize relapsing rates, to limit post-operation complications, to improve the reproductive faculty of seminal fluid both qualitatively and quantitatively, to cut patient's operating costs significantly, to keep the operation time within acceptable limits, and to be easily learned and carried out.
Lymphangioleiomyomatosis (LAM) is a rare pulmonary disease characterized by progressive airflow limitation. We conducted a pilot trial to investigate the incidence of sleep disorders, sleep quality ...and their relationship with disease severity.
We performed pulmonary function tests, blood gas analysis, overnight 12-channels polysomnography and clinical assessments in 15 consecutive LAM patients. For statistics, p values < 0.05 were considered significant.
Sleep efficiency (SE) was inversely correlated with RV/TLC (p = 0.035) and positively with daytime SpO2 (p = 0.010) and PaO2 (p = 0.011). Three cases had obstructive sleep apnea (OSA); seven patients (46.7%) showed a REMOSA. AHIREM was correlated with FEV1% (r = 0.75, p = 0.003), TLC% (r = 0.57, p = 0.026), RV% (r = 0.8, p=<0.0001) and RV/TLC (r = 0.77, p = 0.001). No correlations were observed between anxiety/depression and SE, CAP rate, pulmonary function test variables and AHIREM (p > 0.05). four subjects had nocturnal hypoxia (T90 ≥ 1% of TST) showing lower values of DLCO%, daytime SpO2%, PaO2, FEV1% and a higher value of VR/TLC comparing with the subgroup with normal T90 (p < 0.05).
This pilot study shows that sleep alterations could be frequent in LAM and associated to disease severity. Nocturnal hypoxemia and SE were related to lung function impairment. A dysregulation of sleep seems to involve exclusively REM phase, while NREM appears to be preserved. This phenomenon might be linked to the pathophysiology of disease: our study, even with the limits of the small sample size, showed that the presence of REMOSA is related to the disease severity, in particular to the degree of airflow limitation and hyperinflation. More studies are needed to assess this topic.
•Sleep alterations could be present in Lymphangioleiomyomatosis (LAM).•Sleep alterations seems to be associated to LAM disease severity.•Degree of airflow limitation and hyperinflation correlate with the presence of REMOSA.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
This paper reports on the nanofabrication of a fiber-reinforced polymer nanocomposite (FRPN) by two-photon direct laser writing (TP-DLW) using silica nanowires (SiO2 NWs) as nanofillers, since they ...feature a refractive index very close to that of the photoresist used as a polymeric matrix. This allows for the best resolution offered by the TP-DLW technique, even with high loads of SiO2 NWs, up to 70 wt %. The FRPN presented an increase of approximately 4 times in Young’s modulus (8.23 GPa) and nanohardness (120 MPa) when compared to those of the bare photoresist, indicating how the proposed technique is well-suited for applications with higher structural requirements. Moreover, three different printing configurations can be implemented thanks to the use of silicon chips, on which the SiO2 NWs are grown, as fabrication substrates. First, they can be effectively used as an adhesive layer when the laser beam is focused at the interface with the silicon substrate. Second, they can be used as a sacrificial layer, when the laser beam is focused in a plane inside the SiO2 NW layer. Third, only the outer shell of the object is printed so that the SiO2 NW tangle acts as the internal skeleton for the structure being fabricated in the so-called shell and scaffold printing strategy.
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IJS, KILJ, NUK, PNG, UL, UM