PIN92 Quality of Life Among Hiv Patients: Results from the Ianua Clinical Trial

OBJECTIVES To understand the relationship between socio-demographic variables, clinical factors, highly active anti-retroviral therapy (HAART) and health related quality of life (QoL) in HIV-infected individuals participants in the IANUA multicenter study. METHODS Data relating to patients with HIV infection admitted to 3 infectious disease units in Genoa (Italy) between 2012 and 2014 are collected and analyzed. Univariate and multivariate association of demographic and clinical factors with QoL (computed using EQ-5D-3L) are examined. QoL determinants are assessed using a tobit model, while a logistic model is implemented in order to investigate the relation between specific patients characteristics and the likelihood of having higher QoL. RESULTS Results of the empirical modeling suggest that being Italian and having a job are positively associate with QoL, whereas being a female, taking other drugs in addition to anti-retroviral drugs and being subsidisied are negatively related to QoL. Among clinical factors, CD4 cell count level cannot be considered as significant predictor of QoL, while higher QoL seem to be defined by single tablet regimens. CONCLUSION The study investigates the major determinants of QoL among HIV patients and the results provide some informative tools useful to improve strategies aiming at maximizing QoL. As monitoring of QoL is nowadays a priority for clinicians, further work will be based on \u201cdynamic\u201d analysis comparing QoL at the initial time and QoL at 6-months follow up

The impact of liver disease: a leading cause of hospital admissions in people living vith HIV

Background: This study reviews recent trends of HIV inpatient admissions over 5 Infectious diseases Units in Liguria, in 2012. Patients and Methods: Five infectious diseases Units in Liguria, Italy, collected data on inpatient HIV admissions from January to December 2012, including patient demographic, discharge diagnosis, CD4 Tcell count, viral load (VL) and combined anti-retroviral treatment (cART). Results: Rate of patient admissions per 100 years was 6.12 (number=257), in 62.6% (n=161) of admissions a VL under 50 copies/ml was observed. Furthermore, 86.4% (n=222) of admissions were on active cART. Median age was 49 years. Mortality rate was 10.2%. Hepatitis C coinfection occurred in 64.6% of patients (n=166). The most common diagnosis was infectious diseases (29.1%), respiratory diseases (16.6%) and neoplasms (15.%). Chronic HCV infection and its complications (cirrhosis and hepatocellular carcinoma) accounted for 31% of all discharging diagnosis. Conclusions: The majority of inpatients admitted during 2012 in our Units were on cART and virologically suppressed. The complications of hepatitis C coinfection have a major impact on mortality rates and hospitalization rates in Italy. According to these observations, the availability of new drugs for chronic hepatitis C imposes a further effort to improve the quality of life of our patients

Impact of social determinants on antiretroviral therapy access and outcomes entering the era of universal treatment for people living with HIV in Italy

Background: Social determinants are known to be a driving force of health inequalities, even in high income countries. Aim of our study was to determine if these factors can limit antiretroviral therapy (ART) access, outcome and retention in care of people living with HIV (PLHIV) in Italy. Methods: All ART naïve HIV+ patients (pts) of Italian nationality enrolled in the ICONA Cohort from 2002 to 2016 were included. The association of socio-demographic characteristics (age, sex, risk factor for HIV infection, educational level, occupational status and residency area) with time to: ART initiation (from the first positive anti-HIV test), ART regimen discontinuation, and first HIV-RNA < 50 cp/mL, were evaluated by Cox regression analysis, Kaplan Meier method and log-rank test. Results: A total of 8023 HIV+ pts (82% males, median age at first pos anti-HIV test 36 years, IQR: 29-44) were included: 6214 (77.5%) started ART during the study period. Women, people who inject drugs (PWID) and residents in Southern Italy presented the lowest levels of education and the highest rate of unemployment compared to other groups. Females, pts aged > 50 yrs., unemployed vs employed, and people with lower educational levels presented the lowest CD4 count at ART initiation compared to other groups. The overall median time to ART initiation was 0.6 years (yrs) (IQR 0.1-3.7), with a significant decrease over time [2002-2006 = 3.3 yrs. (0.2-9.4); 2007-2011 = 1.0 yrs. (0.1-3.9); 2012-2016 = 0.2 yrs. (0.1-2.1), p < 0.001]. By multivariate analysis, females (p < 0.01) and PWID (p < 0.001), presented a longer time to ART initiation, while older people (p < 0.001), people with higher educational levels (p < 0.001), unemployed (p = 0.02) and students (p < 0.001) were more likely to initiate ART. Moreover, PWID, unemployed vs stable employed, and pts. with lower educational levels showed a lower 1-year probability of achieving HIV-RNA suppression, while females, older patients, men who have sex with men (MSM), unemployed had higher 1-year risk of first-line ART discontinuation. Conclusions: Despite median time to ART start decreased from 2002 to 2016, socio-demographic factors still contribute to disparities in ART initiation, outcome and durability

An observational comparison of first-line combination antiretroviral treatment (cART) with 2NRTI and ATV/r or DRV/r in HIV-infected patients in Italy

INTRODUCTION: In a recent clinical trial (ACTG 5257), no difference in viral failure (VF) of a first-line cART containing atazanavir/r (ATV/r) or darunavir/r (DRV/r) was found [1]. For the endpoint of discontinuation due to intolerance, the regimen with DRV/r was superior to that of ATV/r (49% of the stops of ATV/r were attributed to jaundice or hyperbilirubinemia). These and other intolerances to ATV/r remain a concern for clinicians. METHODS: Participants in the ICONA Foundation Study who started cART with 2NRTI+ ATV/r or DRV/r while ART-na\uefve were included. Several endpoints were evaluated: confirmed VF>200 copies/mL after six months of therapy, discontinuation of DRV/r or ATV/r for any reasons or because of intolerance/toxicity (as reported by the treating physician) and the combined endpoint of VF or stop. Survival analysis with Kaplan-Meier curves and Cox regression model stratified by clinical site was used. Patients' follow-up accrued from cART initiation to the date of the event or to the date of last available visit/viral load. RESULTS: 894 patients starting 2NRTI+ATV/r and 686 2NRTI+DRV/r when ART-na\uefve on average in 2011 (IQR: 2010-2012) were studied. Most common NRTIs used were FTC/TDF (84%) and ABC/3TC (12%). Median age was 40 years, 22% females, 44% heterosexuals. Patients starting ATV/r were more likely to be hepatitis B/C infected (2% and 14% vs 1% and 9%, p=0.001), they started one year earlier (2011 vs 2012, p=0.001), were more likely to be enrolled in sites located in the north of Italy (63% vs 54%, p=0.04), started cART less promptly after HIV diagnosis (5 vs 2 months, p=0.02) and less likely to have started TDF/FTC (83% vs 85%, p=0.02). By two years of cART, 9.8% (95% CI 7.6-12.0) of those starting ATV/r experienced discontinuation due to intolerance/toxicity vs 6.5% in DRV/r group (95% CI 4.2-8.8, p=0.04). After controlling for several potential confounders (age, gender, nation of birth, mode of HIV transmission, hepatitis co-infection status, AIDS diagnosis, nucleoside pair started, baseline CD4 count and viral load and year of starting cART) the relative hazard (RH) for ATV/r vs DRV/r was 2.01 (95% CI 1.23, 3.28, p=0.005). There were no statistical differences detected for any of the other outcomes. CONCLUSIONS: Although unmeasured confounding cannot be ruled out, our results seem to be consistent with those of the ACTG 5257. When all cause discontinuations were considered, or the composite endpoint of treatment failure, there was no difference between ATV/r- and DRV/r-based regimens

Weight gain: A possible side effect of all antiretrovirals

Weight gain and body mass index (BMI) increase are central issues in patients living with HIV who need to minimize the risk of metabolic disease. Information collected through the SCOLTA cohort revealed significant 1-year BMI increase in patients treated with dolutegravir (P = .004), raltegravir (P = .0004), elvitegravir (P = .004), darunavir (P = .0006), and rilpivirine (P = .029). BMI gain correlated with low baseline BMI (P = .002) and older age (P = .0007) in Centers for Disease Control and Prevention stages A/B, with lower BMI (P = .005) and CD4+ T-cell count (P = .007) at enrollment in stage C

Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: Results from a large observational cohort study (SCOLTA)

Background: Dyslipidemia represents a significant non-infectious comorbidity among people living with HIV. The aim of this study is to evaluate the impact on lipid profile of switches from an efavirenz (EFV) or protease inhibitor/ritonavir (PI/r)-based regimen to a rilpivirine (RPV) or a once-daily integrase inhibitor-based regimen. Methods: We analyzed data from SCOLTA prospective database. All patients with HIV-RNA < 50 copies/ml in therapy with two NRTI + EFV or PI/r were included if they switched from EFV to dolutegravir (group EFV-DTG), elvitegravir (EFV-EVG), or RPV (EFV-RPV) and from PI/r to DTG (PI/r-DTG), PI/r to EVG (PI/r-EVG), or PI/r to RPV (PI/r-RPV). Total cholesterol (TC), TC/HDL ratio, LDL-cholesterol (LDL) and triglycerides (TG) were compared at baseline, six months and one year. Comparisons among groups were performed by a general linear model. Results: Four hundred and ninety patients were enrolled, 24.9% female, mean age 47.3 years (\ub110.1). According to ART switch, 11.4% were classified in group EFV-DTG, 3.9% in EFV-EVG, 23.9% in EFV-RPV, 17.6% in PI/r-DTG, 17.8% in PI/r-EVG, and 25.5% in PI/r-RPV. After adjusted analysis, TC significantly decreased in all groups but EFV-EVG, TC/HDL in all but EFV-DTG and EFV-EVG, while the reduction of TG was significant only in switches to RPV (EFV-RPV and PI/r-RPV). The one year decrease of TC, TC/HDL, LDL and TG was higher in patients with higher baseline levels of the same variable (p < .0001 for all). Conclusions: In SCOLTA, all switches from PI/r regimens gave advantages on lipid profile, while stopping EFV had consistently favorable lipid effects only if replaced by RPV

Daħla

Ġabra ta’ poeżiji u proża li tinkludi: Iva le ta’ Charles Coleiro – Dak li Alla jrid għalih ta’ G. Z. A. – L-univers ta’ P. P. Theuma – Għaddej iż-żmien ta’ Wallace Ph. Gulia – Dawl ċkejken ta’ Dun Frans Camilleri – Meta l-qalb ma tweġibx ta’ A. Cremona – Ħerba ta’ Oliver Friggieri – Is-siġar ta’ Albert M. Cassola – Lill-bandiera Maltija ta’ Mario Agius – Daħla ta’ Emanuele Attard.peer-reviewe