Marco Floridia - Academia.edu (original) (raw)

Papers by Marco Floridia

Antiviral Therapy

Methods Data from a large national surveillance study was used to describe antiretroviral regimen... more Methods Data from a large national surveillance study was used to describe antiretroviral regimens in pregnant women with HIV, with particular reference to the presence at conception of antiretroviral treatments contraindicated in pregnancy. Therapeutic changes during pregnancy were also analysed. Results Among 334 women on antiretroviral treatment at conception, less than half (42.4%) reported current pregnancy as planned. A large number of different regimens (80) was observed. All the regimens included at least one nucleoside or nucleotide reverse transcriptase inhibitor. Non-nucleoside reverse transcriptase inhibitors and protease inhibitors were present in similar proportions (39.2% and 40.7%, respectively). The most commonly used drugs were lamivudine (83.2% of regimens), zidovudine (50.0%), stavudine (d4T; 38.0%), nevirapine (25.7%), didanosine (ddI; 17.7%) and nelfinavir (17.7%). Treament with efavirenz (13.5% of regimens) and ddI+d4T (9.6%) was markedly frequent. Use of efav...

Infection, 2021

To evaluate associations between CD4/CD8 ratio and pregnancy outcomes in women with HIV. We evalu... more To evaluate associations between CD4/CD8 ratio and pregnancy outcomes in women with HIV. We evaluated, in a national study of pregnant women with HIV receiving antiretroviral treatment (ART), values of CD4/CD8 ratio at entry in pregnancy, changes between first and third trimester, and possible associations with preterm delivery, low birthweight, and HIV-RNA < 50 copies/ml at third trimester in univariate and multivariate analyses. Among 934 women, 536 (57.4%) were already on ART at conception. CD4/CD8 ratio (baseline value 0.570) increased significantly between the first and third trimesters, particularly in women who started ART in pregnancy (+ 0.163, vs. + 0.036 in women already on treatment). The rate of CD4/CD8 ratio normalization, defined by achieving a ratio ≥ 1 at the third trimester, was 13.2%. In multivariable analyses, women who entered pregnancy with a CD4/CD8 ratio < 0.3, compared to women with ratio ≥ 1, were almost four-times less likely to have third-trimester HIV-RNA < 50 copies/ml (AOR 0.258, 95%CI 0.111–0.601), and more than twice as likely to have preterm delivery (AOR 2.379, 95%CI 1.082–5.232). For preterm delivery, also a baseline CD4/CD8 ratio between 0.3 and 0.45 was significantly associated with an increased risk (AOR: 3.415, 95%CI 1.690–6.900). We described for the first time independent associations of low CD4/CD8 ratio with preterm delivery and HIV-RNA suppression.

International Journal of Infectious Diseases, 2020

Low mortality rates at two years in HIV-infected individuals undergoing systematic tuberculosis t... more Low mortality rates at two years in HIV-infected individuals undergoing systematic tuberculosis testing with rapid assays at initiation of antiretroviral treatment in Mozambique,

European Journal of Medical Research, 2010

Background: in HIv-infected patients with Hcv-related chronic hepatitis, liver impairment and dru... more Background: in HIv-infected patients with Hcv-related chronic hepatitis, liver impairment and drug toxicity may substantially reduce the number of possible therapeutic options. Case Description: we here describe the case of an Hcv-HIv coinfected woman who had repeated severe episodes of drug-related liver toxicity with indinavir, saquinavir, fosamprenavir, and darunavir, with minimal further therapeutic options left in this class. Previous treatment-limiting side effects with efavirenz and nevirapine also precluded use of non-nucleoside reverse transcriptase inhibitors. Introduction of an integrase-inhibitor regimen based on raltegravir, tenofovir, and emtricitabine allowed a prompt achievement of undetectable viral load and a substantial rise of cd4 count to high levels, with no subsequent episodes of hepatic toxicity, and no other side effects. Conclusions: given the relatively common prevalence of Hcv-related chronic hepatitis among people with HIv, raltegravir might represent an important alternative option for a substantial number of patients who cannot be treated with protease inhibitors or nnRtI because of drug-related hepatic toxicity.

Mediterranean Journal of Hematology and Infectious Diseases, 2019

Background: There is limited information on pregnancy loss in women with HIV, and it is still deb... more Background: There is limited information on pregnancy loss in women with HIV, and it is still debate whether HIV-related markers may play a role. Objectives: To explore potential risk factors for pregnancy loss in women with HIV, with particular reference to modifiable risk factors and markers of HIV disease. Methods: Multicenter observational study of HIV-positive pregnant women. The main outcome measure was pregnancy loss, including both miscarriage…

PLOS ONE, 2018

Background Tuberculosis (TB) represents the ninth leading cause of death worldwide. In 2016 are e... more Background Tuberculosis (TB) represents the ninth leading cause of death worldwide. In 2016 are estimated 1.3 million TB deaths among HIV negative people and an additional 374,000 deaths among HIV positive people. In 2016 are estimated 1.4 million new cases of TB in people living with HIV (PLHIV), 74% of whom were living in Africa. In light of these data, the reduction of mortality caused by TB in PLHIV is strongly required specially in low-income countries as Mozambique. According to international guidelines, the initial TB screening in HIV+ patients should be done with the four symptoms screening (4SS: fever, current cough, night sweats and weight loss). The diagnostic test more used in resource-limited countries is smear microscopy (SMEAR). World Health Organization (WHO) recommended Lateral Flow urine LipoArabinoMannan assay (LF-LAM) in immunocompromised patients; in 2010 WHO endorsed the use of Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) test for rapid TB diagnosis but the assay is not used as screening test in all HIV+ patients irrespectively of symptoms due to cost and logistical barriers. The paper aims to evaluate the cost-effectiveness of three screening protocols: standard (4SS and SMEAR in positive patients to 4SS); MTB/RIF; LF-LAM / MTB/RIF. Methods We developed a model to assess the cost-effectiveness of the MTB/RIF protocol versus the common standard and LF-LAM / MTB/RIF protocol. The model considered a sample of 1,000 HIV+ antiretroviral treatment naïve patients in Mozambique. We evaluated disability

Antiviral therapy, Jan 11, 2017

HIV is transmitted primarily through sexual intercourse, and the objective of this study was ther... more HIV is transmitted primarily through sexual intercourse, and the objective of this study was therefore to assess whether there is occult viral replication and resistance in genital secretions in patients on protease inhibitor (PI)-based second-line therapy. HIV-infected adults taking ritonavir-boosted lopinavir with either two NRTIs, raltegravir, or as monotherapy for 96 weeks were enrolled at seven clinical sites in Uganda. Viral load (VL) was measured in cervico-vaginal secretions or semen and in a corresponding plasma sample. Genotypic resistance was assessed in genital secretion samples and plasma samples. Results were compared between compartments and with the plasma resistance profile at first-line failure. Of the 111 participants enrolled (91 female, 20 male), 16 (14%) and 30 (27%) had VL >1000 and >40 copies/ml respectively in plasma; 3 (3%) and 23 (21%) had VL >1000 copies/ml and >40 copies/ml respectively in genital secretions. There was 74% agreement between p...

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, Jan 9, 2016

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2015

Among 469 women with a diagnosis of HIV in pregnancy, 74 (15.8%) presented with less than 200 CD4... more Among 469 women with a diagnosis of HIV in pregnancy, 74 (15.8%) presented with less than 200 CD4 cells per cubic millimeter. The only variable significantly associated with this occurrence was African origin (odds ratio: 2.22, 95% confidence intervals: 1.32 to 3.75, P = 0.003). Four women with low CD4 (5.6%), compared with none with higher CD4 counts, had severe AIDS-defining conditions (P , 0.001) during pregnancy or soon after delivery, and one transmitted HIV to the newborn. Early preterm delivery (,32 weeks) was significantly more frequent with low CD4 (6.2% vs. 1.4%, P = 0.015). An earlier access to HIV testing, particularly among immigrants of African origin, can prevent severe HIV-related morbidity.

Clinical Infectious Diseases, 2014

of the Istituto Superiore di Sanità in Rome, Italy, for providing technical secretarial assistanc... more of the Istituto Superiore di Sanità in Rome, Italy, for providing technical secretarial assistance for this study. Disclaimer. The corresponding author had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Financial support. This work was supported by public research grants (reference number H85E08000200005) from the Italian Medicines Agency.

Journal of Antimicrobial Chemotherapy, 2010

should the patient require further assessment. Otherwise, the patients are seen by a doctor at le... more should the patient require further assessment. Otherwise, the patients are seen by a doctor at least once every week. All doses ,800 mg are diluted to 20 mL with normal saline. Larger doses are given as the neat 40 mg/mL solution supplied in the manufacturers' vials. In the period between November 1995 and October 2009, we documented the administration of 5593 doses (3652 of tobramycin and 1941 of gentamicin). The drugs were administered in 361 courses (244 of tobramycin and 117 of gentamicin) to 132 patients. Sixty-seven of these patients had cystic fibrosis and received multiple courses. Twelve of the remaining 65 had bronchiectasis and also received more than one course. The other remaining patients were treated for a variety of diagnoses, typically requiring only one course. One hundred and forty-five courses were administered to children and 216 to adults. The ages of the patients ranged from 3 to 84 years. The median dose was 360 mg of tobramycin and 320 mg of gentamicin in cystic fibrosis, and 240 mg of tobramycin and 170 mg of gentamicin in those without cystic fibrosis. The median course duration was between 15 and 18 days across the same groups. One patient, a middle-aged female with complex medical problems, developed vestibular toxicity and some hearing loss 16 h after her last dose of 320 mg of tobramycin. There has never been the suggestion of neuromuscular toxicity or hearing loss at the time of injection. Current recommendations are that tobramycin and gentamicin be given by infusion over ≥30 min. 1 We have shown that tobramycin and gentamicin can be safely administered by slow push over 3-5 min. We recommend that consideration be given to the use of this simple method as the standard of care. Funding This study was carried out as part of our routine work.

Journal of Antimicrobial Chemotherapy, 2008

Objectives: Antiretroviral combinations including atazanavir are currently not recommended in HIV... more Objectives: Antiretroviral combinations including atazanavir are currently not recommended in HIV-infected patients with end-stage liver disease (ESLD). The objective of our study was to evaluate efficacy, pharmacokinetics and safety of unboosted atazanavir in HIV-infected patients with ESLD screened for orthotopic liver transplantation (OLT x). Patients and methods: Single-arm, 24 week pilot study. Atazanavir-naive patients undergoing highly active antiretroviral therapy were switched to atazanavir 400 mg/day plus two non-thymidine nucleoside reverse transcriptase inhibitors. Results: Fifteen patients (10 males and 5 females) were included. In the study period, 2 patients were transplanted and 10 completed 24 weeks of atazanavir treatment. Median area under the concentration-time curve at week 4 was 19 211 ng. h/mL (IQR 5 8959-27 500). At week 24, median atazanavir trough concentrations (C trough) per patient calculated across the study were above the minimum effective concentration (MEC 5 100 ng/mL) in 8 of 10 subjects. Atazanavir C trough time-point values were always above the MEC in five patients. The other three subjects experienced only one determination below the MEC, with median atazanavir C trough levels across the study being above the MEC in two of them. At 8 of 11 time-points when atazanavir and proton pump inhibitors (PPIs) were co-administered and at 16 of 19 time-points in which patients had a concomitant tenofovir association, atazanavir C trough was above the MEC. Conclusions: Unboosted atazanavir showed a favourable pharmacokinetic profile and was able to maintain or gain immuno-virological eligibility for OLT x in all patients. Limited biochemical toxicities (including unconjugated hyperbilirubinaemia) and allowance of concomitant administration of tenofovir and PPIs were observed.

HIV Clinical Trials, 2008

Few studies have assessed the determinants of birthweight in newborns from HIV-positive mothers i... more Few studies have assessed the determinants of birthweight in newborns from HIV-positive mothers in analyses that adjusted for different gestational age at delivery. We calculated gestational age-adjusted birthweight Z-score values in a national series of 600 newborns from women with HIV and in 600 newborns from HIV-negative women matched for gender and gestational age. The determinants of Z-score values in newborns from HIV-positive mothers were assessed in univariate and multivariate regression analyses. Compared to newborns from HIV-negative women, newborns from HIV-positive women had significantly lower absolute birthweight (2799 vs. 2887 g; p = .007) and birthweight Z score (-0.430 vs. -0.222; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Among newborns from mothers with HIV, the maternal characteristics associated with significantly lower Z-score values in univariate analyses were recent substance use (Z-score difference [ZSD] 0.612, 95% CI 0.359-0.864, p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001), smoking &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10 cigarettes/day (ZSD 0.323, 95% CI 0.129-0.518, p = .001), absence of pregnancies in the past (ZSD 0.200, 95% CI 0.050-0.349, p = .009), no antiretroviral treatment in the past (ZSD 0.186, 95% CI 0.044-0.327, p = .010), and Caucasian ethnicity compared to Hispanic (ZSD 0.248, 95% CI 0.022-0.475, p = .032). Body mass index (BMI) at conception and maternal glycemia levels during pregnancy were also significantly related to birthweight Z scores. Glycemia, BMI, and recent substance use maintained a significant association with Z-score values in multivariate analyses. In the multivariate analysis, the only factors significantly associated with Z-score values below the 10th percentile were recent substance use (adjusted odds ratio [AOR] 3.17, 95% CI 1.15-8.74) and smoking (AOR 2.26, 95% CI 1.13-4.49). We identified several factors associated with gestational age-adjusted birthweight in newborns from women with HIV. Smoking and substance use have a significant negative impact on intrauterine growth, which adds to an independent HIV-related effect on birthweight. Prevention and information on this issue should be reinforced in women with HIV of childbearing age to reduce the risk of negative outcomes in their offspring.

Epidemiology and Infection, 2006

We analysed the characteristics of the pregnancies with a previously undetected HIV infection in ... more We analysed the characteristics of the pregnancies with a previously undetected HIV infection in a national observational study of pregnant women with HIV in Italy. In a total of 443 pregnancies with available date of HIV diagnosis, 118 were characterized by a previously undetected HIV infection (26·6%, 95% CI 22·5–30·8). The following factors were independently associated with this occurrence in a multivariate analysis (adjusted odds ratios; 95% CIs): foreign nationality (5·1, 2·8–9·3); no pre-conception counselling (35·9, 4·8–266·1); first pregnancy (2·1, 1·2–4·0); asymptomatic status (6·8, 1·5–30·6). Women with previously undetected infection started antiretroviral treatment significantly later during pregnancy (P<0·001). Missed diagnosis was responsible for one case of transmission. A high rate of previously undetected HIV infection was observed. This suggests a good HIV detection during pregnancy, but also the need to reinforce HIV testing strategies among women of childbear...

Epidemiology and Infection, 2010

SUMMARYWe assessed recent trends in hepatitis C virus (HCV) prevalence in pregnant women with HIV... more SUMMARYWe assessed recent trends in hepatitis C virus (HCV) prevalence in pregnant women with HIV using data from a large national study. Based on 1240 pregnancies, we observed a 3·4-fold decline in HCV seroprevalence in pregnant women with HIV between 2001 (29·3%) and 2008 (8·6%). This decline was the net result of two components: a progressively declining HCV seroprevalence in non-African women (from 35·7% in 2001 to 16·7% in 2008), sustained by a parallel reduction in history of injecting drug use (IDU) in this population, and a significantly growing presence (from 21·2% in 2001 to 48·6% in 2008) of women of African origin, at very low risk of being HCV-infected [average HCV prevalence 1%, adjusted odds ratio (aOR) for HCV 0·09, 95% CI 0·03–0·29]. Previous IDU was the stronger determinant of HCV co-infection in pregnant women with HIV (aOR 30·9, 95% CI 18·8–51·1). The observed trend is expected to translate into a reduced number of cases of vertical HCV transmission.

Clinical Infectious Diseases, 2011

BJOG: An International Journal of Obstetrics & Gynaecology, 2007

We used data from the main surveillance study of HIV and pregnancy in Italy to evaluate possible ... more We used data from the main surveillance study of HIV and pregnancy in Italy to evaluate possible differences in pregnancy care and outcomes according to nationality. Among 960 women followed in 2001-06, 33.5% were of foreign nationality, mostly from African countries. Foreign women had lower rates of preconception counselling and planning of pregnancy. They had more frequently HIV diagnosed during pregnancy, with a later start of antiretroviral treatment and lower treatment rates at all trimesters but not when the entire pregnancy, including delivery, was considered. No differences were observed between the two groups in ultrasonography assessments, hospitalisations, AIDS events, intrauterine or neonatal deaths, and mode and complications of delivery. Foreign women had a slightly lower occurrence of preterm delivery and infants with low birthweight. The results indicate good standards of care and low rates of adverse outcomes in pregnant women with HIV in Italy, irrespective of nationality. Specific interventions, however, are needed to increase the rates of counselling and HIV testing before pregnancy in foreign women.

Antimicrobial Agents and Chemotherapy, 2000

The prevalence and the genotypic and phenotypic characteristics of multinucleoside-resistant (MNR... more The prevalence and the genotypic and phenotypic characteristics of multinucleoside-resistant (MNR) human immunodeficiency virus type 1 (HIV-1) variants in Europe were investigated in a multicenter study that involved centers in nine European countries. Study samples ( n = 363) collected between 1991 and 1997 from patients exposed to two or more nucleoside analogue reverse transcriptase inhibitors (NRTIs) and 274 control samples from patients exposed to no or one NRTI were screened for two marker mutations of multinucleoside resistance (the Q151M mutation and a mutation with a 2-amino-acid insertion at codon 69, T69S-XX). Q151M was identified in six of the study samples (1.6%), and T69S-XX was identified in two of the study samples (0.5%; both of them T69S-SS), but both patterns were absent among control samples. Non-NRTI (NNRTI)-related changes were observed in viral strains from two patients, which displayed the Q151M resistance pattern, although the patients were NNRTI naive. The ...

AIDS Research and Human Retroviruses, 2007

The health-related quality of life (HRQoL) outcomes in HIV-infected, treatment-naive patients sta... more The health-related quality of life (HRQoL) outcomes in HIV-infected, treatment-naive patients starting different HAART regimens in a 3-year, randomised, multinational trial were compared. HRQoL was measured in a subgroup of patients enrolled in the INITIO study (153/911), using a modified version of the MOS-HIV questionnaire. The regimens compared in the INITIO trial were composed by two NRTIs (didanosine+stavudine) plus either a NNRTI (efavirenz) or a PI (nelfinavir), or both (efavirenz+nelfinavir). Primary HRQoL outcomes were Physical and Mental Health Summary scores (PHS and MHS, respectively). During follow up, an increase of PHS score was observed in all treatment arms. The MHS score remained substantially unchanged with the 4-drug combination and showed with both NNRTI-and PI-based 3-drug regimens a marked trend toward improvement, which became statistically significant when a multiple imputation method was used to adjust for missing data. Overall, starting all the combination regimens compared in the INITIO study was associated to a maintained or slightly improved HRQOL status, consistently with the positive immunological and virological changes observed in the main study. The observed differences in the MHS indicate a possible HRQoL benefit associated to the use of 3-drug, 2-class regimens and no additional benefit for the use of 4-drug, 3-class regimens, confirming that 3-drug, 2-class regimens which include 2NRTIs plus either a NNRTI or a PI should be preferred as initial treatment of HIV infection.

AIDS Patient Care and STDs, 2009

Limited information is currently available on the metabolic profile of nevirapine in pregnancy. W... more Limited information is currently available on the metabolic profile of nevirapine in pregnancy. We used data from a national observational study to evaluate plasma lipid profile in pregnant women receiving nevirapine. Lipid values were collected during routine clinical visits. Midpregnancy (second trimester) lipid values were analyzed according to use of nevirapine, calculating differences and 95% confidence intervals (CI) between women taking and not taking this drug. In order to adjust for possible confounders, multivariable models were constructed using as dependent variables levels of total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), triglyceride (TG) levels and TC/HDL-C ratio, and as independent variables age, body weight, previous treatment history, CD4 count, and presence of any antiretroviral therapy, use or nonuse of protease inhibitors, stavudine, and nevirapine at the time of blood sampling. Overall, 375 women had available data for analysis. Pregnant women on nevirapine, compared to women not taking this drug, had in univariate analyses higher levels of HDL-C (difference: +13.0mg/dL [95%CI 7.4-18.6], p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001), lower values of TC/HDL-C ratio (difference: -0.51 [0.23-0.80], p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) and a trend for lower levels of triglycerides (difference: -17.6mg/dL [0.7-35.9], p = 0.06). Higher HDL-C levels were also associated with use of protease inhibitors and with no previous antiretroviral experience before pregnancy. The associations with higher HDL-C levels were confirmed in multivariable analyses. Our study indicates in pregnant women an association between nevirapine use and higher HDL-C levels. Further studies should assess whether this effect is due to an intrinsic activity of nevirapine and define the potential mechanisms involved.