Showing papers by "Elena Ricci published in 2020"

Factors Associated With Weight Gain in People Treated With Dolutegravir

Abstract: Background An unexpected excess in weight gain has recently been reported in the course of dolutegravir (DTG) treatment. The aim of the present study was to investigate whether weight gain differs among different DTG-containing regimens. Methods Adult naive and experienced people with HIV (PWH) initiating DTG-based antiretroviral therapy (ART) between July 2014 and December 2019 in the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) prospective cohort were included. We used an adjusted general linear model to compare weight change among backbone groups and a Cox proportional hazard regression model to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for weight increases >10% from baseline. Results A total of 713 participants, 25.3% women and 91% Caucasian, were included. Of these, 195 (27.4%) started DTG as their first ART regimen, whereas 518 (72.6%) were ART-experienced. DTG was associated with abacavir/lamivudine in 326 participants, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 148, boosted protease inhibitors in 60, rilpivirine in 45, lamivudine in 75, and tenofovir alafenamide (TAF)/FTC in 59. At 6 and 12 months, weight gain was highest among PWH on TDF/FTC+DTG and TAF/FTC+DTG. Baseline CD4 10% from baseline. Higher weight (HR, 0.97 by 1 kg; 95% CI, 0.96 to 0.99) and female gender (HR, 0.54; 95% CI, 0.33 to 0.88) were protective against weight gain. Conclusions Naive PWH with lower CD4 counts and those on TAF/FTC or TDF/FTC backbones were at higher risk of weight increase in the course of DTG-based ART.

Factors associated with hospital admission for COVID-19 in HIV patients.

Abstract: This study reports on hospital admission and outcomes of 69 HIV-infected individuals who were diagnosed with SARS-CoV-2 infection between February and May 2020, in a network of Italian centres. Patients' characteristics and median days between symptoms and diagnosis were similar by hospital admission, whereas admitted patients had lower nadir CD4 cells and current lymphocytes count. These values were also correlated to worse COVID-19 outcome. Antiretroviral drugs did not seem to be associated with disease severity.

The Effect of Switching from Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide (TAF) on Liver Enzymes, Glucose, and Lipid Profile.

Abstract: Objective We aimed to investigate the effect of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on the hepatic safety and metabolic profile. Methods Consecutive HIV patients, enrolled in the Surveillance Cohort Long-term Toxicity Antiretrovirals/Antivirals (SCOLTA) project, switching from TDF to TAF were included. Changes from baseline (T0) to 6-month follow-up (T1) were evaluated using paired t-test and signed rank test. Results A total of 190 patients switched from TDF to TAF and had one 6-month follow-up visit. They were 80% male, 74.2% at CDC stage A–B, 93.7% with undetectable HIV-viral load. Mean age was 46.7±10.7 years, body mass index was 25.0±3.9 kg/m2, median CD4 cell count was 634 cell/µL (interquartile range [IQR]=439–900), aspartate aminotransferase (AST) was 23 (IQR=19–30) IU/L, and alanine aminotransferase (ALT) was 24 (IQR=17–34) IU/L. At T1, both AST (median=−1, IQR=−5–2 IU/L, P=0.004) and ALT (median=−2, IQR=−7–3 IU/L, P=0.0004) showed a significant decrease. Among 28 patients with ALT >40 at baseline, reduction was significant both clinically (−17, IQR=−32–−1) and statistically (P=0.0003). Total cholesterol levels (TC) increased (+13.4±3.8 mg/dL, P=0.0006), as well as HDL-cholesterol (HDL-C) (+3.8±1.2 mg/dL, P=0.02), LDL Cholesterol (LDL-C) (+7.6±3.4, P=0.03) and glucose (+4.0±1.8 mg/dL, P=0.02). D:A:D: and Framingham risk score did not change at 6 months after switch. Conclusion A significant reduction of liver enzymes was observed after switching from TDF to TAF, especially in subjects with initial level of ALT >40 IU/L. Glucose, TC, HDL-C, and LDL-C increased, with no effect on cardiovascular risk scores.

Smoking habits in HIV-infected people compared with the general population in Italy: a cross-sectional study

Abstract: Tobacco use is a leading cause of preventable diseases and death for all individuals, even more so for people living with HIV (PLWH), due to their status of chronic inflammation. To date, in Italy no study was performed to compare smoking habits in PLWH and the general population. We aimed to investigate smoking habits in PLWH, as compared to the general population. Multi-center cross-sectional study. Smoking habits were compared between PLWH and the general population. PLWH were enrolled in the STOPSHIV Study. The comparison group from the general population was derived from a survey performed by the National Statistics Institute (ISTAT), with a stratified random sampling procedure matching 2:1 general population subjects with PLWH by age class, sex, and macro-area of residence. The total sample consisted of 1087 PLWH (age 47.9 ± 10.8 years, male 73.5%) and 2218 comparable subjects from the general population. Prevalence of current smokers was 51.6% vs 25.9% (p 20 cigarettes per day) (aOR = 4.84; 95% CI = 3.74–6.27; p < 0.001). PLWH were less likely to have quitted smoking (aOR = 0.36; 95% CI = 0.29–0.46; p < 0.001). HIV-infected patients showed a higher rate of current smokers, a larger number of cigarettes smoked and a lower quitting rate than the general population. Our findings emphasize the need for smoking cessation strategies targeting HIV persons.

Dietary Carbohydrate Intake, Dietary Glycemic Load and Outcomes of In Vitro Fertilization: Findings from an Observational Italian Cohort Study.

Abstract: In recent decades, increasing attention has been paid to the influence of diet on reproductive health. Carbohydrates in diet affect glucose metabolism and multiple evidences showed the key role of insulin sensitivity in regulating female fertility. We designed a prospective cohort study to investigate the relation between dietary carbohydrate intake, glycemic load (GL) and the outcomes of assisted reproduction. A population of 494 female partners of couples referring to an Italian Fertility Center and eligible for in vitro fertilization (IVF) were enrolled in the study. On the day of the oocyte retrieval, information on their diet was obtained using a validated food frequency questionnaire (FFQ). We calculated the relative risk and 95% confidence interval of embryo transfer, clinical pregnancy and live birth according to the following dietary exposures: GL, glycemic index (GI) as well as the daily carbohydrate and fiber intake. A multiple regression model was used to account for the confounders. After adjusting for age, college degree, body mass index (BMI), leisure physical activity and previous assisted reproduction techniques (ART) cycles, no significant association was observed between the considered dietary exposures and the IVF outcomes. The roles of GL, carbohydrate intake and GI were assessed in strata of the cause of infertility and body mass index and no relation emerged in this further analysis. We found no clear association between the dietary carbohydrate quantity and quality and IVF outcomes in a cohort of infertile Italian women.

Bone Safety of Dolutegravir-Containing Regimens in People Living with HIV: Results from a Real-World Cohort.

Abstract: Objective Few data exist about the effect of dolutegravir (DTG) on bone mineral density (BMD) in real life. The aim of this study was to determine rates of change in BMD over time in people living with HIV (PLWH) treated with DTG. Design The SCOLTA project is a multicenter observational study enrolling HIV-infected people who start newly commercialized drugs prospectively, with the aim of identifying toxicities and adverse events (AE) in a real-life setting. Methods Dual-energy X-ray absorptiometry at the femoral neck (FN) and lumbar spine (LS) was performed at study entry (baseline, BL) and after 96 weeks. Percentage BMD change from BL was evaluated using a general linear model, including factors potentially associated with bone loss. Results One hundred and sixty PLWH were enrolled (26.3% female, mean age 49.9 ± 11.2 years) from April 2015 to April 2017. Overall, we could calculate BMD change from baseline, for at least one site, in 133 subjects (83.1%). After a median of 102 weeks (IQR: 90-110), mean FN BMD increased, but not significantly, whereas LS BMD showed a significant mean increase of 13.1 (95% confidence interval, CI: 1.7-24.6) mg/cm3 (+1.6%, 95% CI: 0.3%, 2.8%) after a median time of 102 weeks (IQR: 84-110). As regards LS BMD, patients with osteopenia/osteoporosis at study entry experienced a high increase from baseline (20.6, 95% CI: 3.1, 38.1 mg/cm3), as well as experienced subjects (16.9, 95% CI: 4.7, 29.2 mg/cm3) and those on vitamin D supplementation (26.8, 95% CI: 7.7, 45.9 mg/cm3). Conclusion Dolutegravir-containing regimens could reduce the negative impact of antiretroviral therapy on bone, especially in patients with low BMD.

Smoking Habits in Human Immunodeficiency Virus-Infected People from Italy: A Cross-Sectional Analysis of the STOPSHIV Cohort

Abstract: In a nationwide Italian sample of people living with HIV (PLWH), the prevalence of smoking, nicotine dependence, propensity to stop smoking, and cardiovascular profile were investigated. The nicoti...

Pretreatment maternal lifestyle and outcomes of assisted reproduction: an Italian cohort study

Abstract: Objective We investigated whether lifestyle affects assisted reproduction technology (ART) outcomes. Design Cohort study. Setting Italian fertility unit. Participants From September 2014 to December 2016, women from couples presenting for evaluation and eligible for ART were invited to participate. Information on alcohol intake, current smoking and leisure physical activity (PA) during the year before the interview was collected, using a structured questionnaire. We considered the ART outcomes of the cycle immediately following the interview. Primary and secondary outcome measures The primary outcome measure was cumulative pregnancy rate per retrieval. Secondary measures were number of retrieved oocytes, embryo transfer and live birth. Results In 492 women undergoing an ART cycle, 427 (86.8%) underwent embryo transfer, 157 (31.9%) had at least one clinical pregnancy and 121 (24.6%) had live birth. The cumulative pregnancy rate per retrieval was 33.3% (95% CI 28.5% to 38.7%). In women in the third tertile of alcohol intake, adjusted relative risk was 0.97 (95% CI 0.87 to 1.08), 0.90 (95% CI 0.62 to 1.30) and 0.89 (95% CI 0.57 to 1.37) for embryo transfer, clinical pregnancy and live birth, respectively. The corresponding figures in women currently smoking more than 5 cigarettes/day were 1.00 (95% CI 0.88 to 1.16), 0.94 (95% CI 0.60 to 1.48) and 1.14 (95% CI 0.68 to 1.90), and in women with PA ≥5 hours/week were 0.93 (95% CI 0.79 to 1.08), 0.44 (95% CI 0.22 to 0.90) and 0.48 (95% CI 0.22 to 1.05), respectively. Conclusion There were no significant differences in in vitro fertilisation outcomes among women who used alcohol or tobacco in the year prior to treatment. Conservatively, all women should be advised to limit substance abuse. Moreover, our study suggested that maintaining a moderate, but not high, level of PA could be beneficial.

The role of diet in unexpected poor response to ovarian stimulation: a cross-sectional study.

Abstract: Research question Is there an association between diet and poor ovarian response to ovarian stimulation in women with normal biomarkers of ovarian reserve? Design Women eligible for IVF at an Academic Fertility Center were invited to participate in this prospective cross-sectional study. The main inclusion criteria were age 18–39 years, body mass index 18–25 kg/m2, preserved ovarian reserve (antral follicle count 10–22 or anti-Mullerian hormone concentration 2–5 ng/ml) and a starting dose of gonadotrophins of 150–225 IU/day. Information on diet was obtained using a validated food frequency questionnaire. ‘Unexpected poor ovarian response' was defined as the retrieval of three or fewer suitable oocytes. A logistic regression model was used to adjust for confounders. Results Out of the 303 women enrolled in the study, 48 (16%) showed an unexpected poor ovarian response. The frequency of poor responders increased with increasing glycaemic load, carbohydrate intake and fibre intake. When comparing the third with the first tertile (reference), the adjusted odds ratios for these were 3.91 (95% confidence interval [CI] 1.11–13.83, P = 0.04), 4.78 (95% CI 1.23–18.51, P = 0.02) and 6.03 (95% CI 1.18–30.77, P = 0.07), respectively. Conclusions Elevated dietary glycaemic load as well as carbohydrate intake and fibre intake is significantly associated with unexpected poor ovarian response. Future interventional studies should clarify whether dietary modification might restore normal response.

Is It Feasible to Impact on Smoking Habits in HIV-Infected Patients? Mission Impossible From the STOPSHIV Project Cohort.

Abstract: OBJECTIVE Assessment of the feasibility and effectiveness of a brief intervention for smoking cessation in people living with HIV (PLWH). SETTING Multicenter cohort prospective study involving PLWH from 10 Italian infectious disease centers. METHODS During routine HIV care, clinicians delivered the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to each patient who enrolled in the study, following the European AIDS Clinical Society guidelines. At study end, participating clinicians evaluated their own adherence to intervention: "standard" if counseling was delivered in at least half of the follow-up visits, "soft" if less. The main outcome measure was smoking abstinence ≥6 months. Abstinence predictors were evaluated using a Cox-proportional hazard regression model. RESULTS One thousand eighty-seven PLWH-patients (age 47.9 ± 10.8, male 73.5%) were followed for a median of 23 months (interquartile range 21-25). At baseline, current smokers were 561 (51.6%). Standard intervention was performed in 4 of 10 centers and included 343 smokers; soft intervention was performed in 6 centers (218 smokers). At last visit, 35 patients in standard (10.8%) and 6 in soft intervention (2.8%) achieved self-reported tobacco abstinence ≥6 months (P = 0.0009). Overall, the 5As intervention led to 7.3% 6-month interruptions. In the multivariable analysis, significant predictors for 6-month smoking cessation were: lower Fagerstrom score, stage of change (preparation/contemplation vs. precontemplation), and standard intervention. CONCLUSION Adherence to the 5As brief intervention emerged as a critical factor for success. In fact, compared with soft intervention, the standard intervention significantly increased abstinence, highlighting that clinicians need more time and supporting tools to encourage PLWH to quit smoking.

Fatty acids, food groups and semen variables in men referring to an Italian Fertility Clinic: Cross-sectional analysis of a prospective cohort study.

Abstract: Diet has been suggested as a factor affecting sperm quality, both in healthy and infertile men. To study whether specific food groups and fatty acids (FA) intake were associated with sperm parameters of men from couples referring to an Italian Fertility Clinic, we conducted a cross-sectional analysis. A semen sample was collected and analysed before proceeding with assisted reproduction. To evaluate food groups and fatty acids intake, we used a questionnaire of food frequency. We calculated odds ratios (OR) and 95% confidence intervals (CI) for abnormal semen parameters. Among 323 men, 19% had semen volume (SV) <1.5 ml, 31% sperm concentration (SC) <15 mil/mL, 33% total sperm count (TSC) <39 mil and 27% sperm progressive motility <32%. Low SC was more frequent in men with higher saturated FA (SFA) and polyunsaturated FA (PUFA) intake. Better SC and TSC were related to higher monounsaturated FA (MUFA)/SFA ratio. Monounsaturated FA and linoleic/linolenic acid ratio were not related to any considered parameters. Low TSC was associated with low vegetable intake. In conclusion, normal sperm parameters were more frequent in men with low intake of SFA and PUFA, and high vegetable intake. Higher MUFA/SFA ratio was associated with better sperm quality parameters.