Severe Acute Hepatitis B Treated With Entecavir.

Hepatitis B virus (HBV) infection constitutes a serious global health problem. Nowadays there are divergent data regarding the use of antiviral drugs to treat acute hepatitis B. We present here a case of a 62-year-old man affected by severe acute hepatitis B with progressive worsening of clinical and hepatic function. The patient was treated with entecavir without critical side effects. We observed rapid clinical and laboratory improvements and the disappearance of hepatitis B surface antigen (HBsAg). The treatment with entecavir was protracted until 17th week when the antibody anti-HBs appeared. Entecavir should be carefully considered for the treatment of severe acute hepatitis B cases

Efficacy of 1998 <i>vs</i> 2006 first-line antiretroviral regimens for HIV infection: an ordinary clinics retrospective investigation

Purpose: The evidence suggesting increased HAART efficacy over time comes from randomized trials or cohort studies. This retrospective multicenter survey aimed to assess the variation over time in the efficacy and tolerability of first-line HAART regimens in unselected patients treated in ordinary clinical settings. Methods: Retrospective analysis of data of all patients starting first-line HAART regimens in 1998 and 2006 at adhering centers in the Italian CISAI group. Results: For the 543 patients included, mean age was 39.1 ± 9.8y in 1998 and 41.0 ± 10.7y in 2006 (p=0.03), with a similar proportion of males. Baseline mean log10 HIV-RNA was 4.56 ± 0.97 copies/mL in 1998 vs 4.91 ± 0.96 copies/mL in 2006 (p&lt;0.001); baseline mean CD4 T-cell counts were 343 ± 314/mm3 in 1998 vs 244 ± 174/mm3 in 2006 (p&lt;0.001). The following outcomes were significantly improved at 48w in 2006: proportion with undetectable HIV-RNA (86.3% vs 58.0%; p&lt;0.001); mean increase in CD4 T-cells count (252 ± 225 vs 173 ± 246; p&lt;0.001); HAART modification (20.1% vs 29.2%; p=0.02); HAART interruption (7.3% vs 14.6%; p=0.01); proportion reporting optimal adherence (92.2% vs 82.7%, p=0.03). No differences were observed in the prevalence of grade 3-4 WHO toxicities (26.4% vs 26.6%; p=0.9). Multivariate logistic regression showed that being treated in 1998 remained an independent predictor of virological failure after several adjustments, including adherence. Conclusions: Our data from patients not included in clinical trials or cohort studies provide an additional line of evidence that the effectiveness of HAART significantly improved in 2006. Treated patients, however, were significantly older and more frequently late HIV presenters in 2006 than in 1998.</br

Comparison of the efficacy at 48 weeks of first-line antiretroviral treatment for HIV infection in 1998 and 2006: a multicentric investigation

HAART efficacy for HIV-infected patients increased over time as more drugs and novel drug classes became available. It is not yet fully clear, however, which factors are most relevant to the increased success of more recent first-line regimens. We therefore planned to retrospectively investigate the efficacy of first-line regimens prescribed at our Institutions in 1998 and 2006

Long-term efficacy of boosted and unboosted atazanavir-containing regimens: results from the SCOLTA project

In this study we evaluated the efficacy of boosted and unboosted ATV in different regimens in a cohort of HIV-1 infected patients

Chronological and biological age in HIV infection

Several studies have so far documented the dramatic impact of highly active antiretroviral therapy (HAART) in improving survival estimates of HIV-infected patients. Within such a scenario, the growing impact of cardiovascular disease and accelerated biological aging is of particular concern. Indeed, HIV-infected patients are generally considered a special population experiencing an acceleration of the aging process, as well as a substantial burden of additional co-morbidity. An important role in determining premature aging has been attributed to conventional cardiovascular risk factors, as these are widely prevalent in HIV-infected people. A better evaluation of their impact may be provided by the estimate of vascular age as calculated by a new sex-specific multivariable risk factor algorithm derived from the Framingham Heart Study. It includes age, total and HDL-cholesterol, blood pressure, diabetes and tobacco use. This equation may be applied to obtain a derived estimate of vascular age in the general population. The aim of our present investigation was to estimate the difference between chronological age and vascular age, calculated using the Framingham equation, in a large cohort of HIV-infected patients. In 2 recent multicenter Italian studies, “SIM-One” and “HERMES”, we collected clinical and laboratory data, including information on cardiovascular risk factors, on 1243 HIV-infected patients (most on HAART) and 317 antiretroviral naïve HIV patients, respectively. The main characteristics of evaluated patients are summarized in Table 1. The estimated vascular age was higher than chronological age in both groups (+6.0 and +4.2 in SIM-One and HERMES, respectively)

Cholesterol levels in HIV–HCV infected patients treated with lopinavir/r: results from the SCOLTA project

Background. It is not known whether antiretroviral therapy (ART) including lopinavir/r has a different effect on the lipid metabolism in HIV patients co-infected with HCV. This study investigated changes in lipid levels, comparing patients with HIV infection alone and those with HCV too, in the lopinavir/r cohort of the SCOLTA project. Methods. We analyzed the data for the lopinavir/r nationwide cohort from 25 Italian infectious disease departments, which comprises 743 HIV-infected patients followed prospectively, comparing subjects with HIV–HCV co-infection and those with single-infection. Results. At enrolment, co-infected patients had significantly lower mean cholesterol than HCV negative cases (162 ± 43 mg/dL vs. 185 ± 52 mg/dL, p = 0.0009). Total and non-HDL cholesterol and triglycerides rose significantly from baseline in HIV single-infection patients, but not in those with co-infection. The patients with dual HIV–HCV infection, treated with an ART regimen including lopinavir/r, have only limited increases in total and non-HDL cholesterol and triglycerides. Conclusions. Changes in serum lipids in co-infected patients differed significantly from those in patients without HCV. It remains to be seen whether this is associated with a lower risk of progression of atherosclerotic disease

Identifying HIV patients with an unfavorable cardiovascular risk profile in the clinical practice: results from the SIMONE study

Objective. To identify and characterize HIV-infected patients at higher cardiovascular risk in ordinary clinical settings. Design. Multicenter, nationwide cross-sectional study. Methods. Consecutive HIV-patients, attending scheduled visits at facilities involved in the Italian coordination group for the study of allergies and HIV infection (CISAI), were included between February and April, 2005. Their 10-year probability of acute coronary events was calculated using the Framingham Risk Score (FRS) as well as 3 other cardiovascular algorithms (“PROCAM”, “PROGETTO CUORE”, “SCORE”); Metabolic Syndrome (MS) was diagnosed according to the National Cholesterol Education Program definitions. An estimated 10-year CVD ≥10% and/or MS led to the diagnosis of high CV risk. We compared selected clinical features between high- and low-risk patients. Results. A total of 1230 HIV infected patients (72% males, mean age of 43 ± 9 years), 185 of whom treatment-naïve, were evaluated. FRS gave the highest estimate of CV risk. The mean 10-year risk for acute coronary events according to FRS was 7.4 ± 7.0. MS was present in 22% of the observed patients. Accordingly, 443 patients (36%) were classified at high risk. Twelve percent of the patients (n = 142) had both a FRS ≥10% and a diagnosis of MS. The main single predictor of increased cardiovascular risk was smoking (60% of whole sample). A higher prevalence of clinically evident lipodystrophy and a higher CD4 T-cell counts were found both in patients with higher FRS and in patients with high FRS and MS (both p &lt; 0.001). Conclusions. The worst estimation of CV risk was obtained with the FRS algorithm. Clinical evidence of lipodystrophy and higher CD4 T-cell counts were closely associated to a worse cardiovascular risk profile

The Feature of metabolic syndrome in HIV naive patients is not the same of those treated: results from a prospective study

Metabolic Syndrome (MS) is a common disorder combining obesity, dyslipidemia, hypertension, and insulin resistance. Its prevalence among HIV-infected people is still debated. Besides, how antiretroviral therapy and HIV infection per se are related to MS is still unclear. All treatment-naïve patients attending scheduled visits at CISAI group hospitals between January and December 2007 were eligible for the study. Patients without MS at enrolment were followed-up for 3 years or until they developed MS, diagnosed according to the National Cholesterol Education Program (NCEP) definition. The main objective was to assess the 3-years incidence of MS. MS was evaluated for 188 subjects. Out of them, 62 (33.0%) had started HAART at enrolment, whereas 67 (35.6%) more started during the observation. 59 (31.4%) were still treatment-naive at the study end. MS was newly diagnosed in 14 patients. The incidence was 2.60 cases/100 person-years (95% CI 1.47–4.51), 2.75 (1.11–5.72) among HAART-naïve patients and 2.65 (1.23–5.03) in subjects on HAART. Blood pressure did not change in the study period, whereas in naive patients the HDL level significantly lowered (median –6.0 vs. 4.0, P &lt; 0.0001) compared to HAART-treated patients. Triglicerides increased significantly in HAART subjects (median 12.0 vs. 1.0, P = 0.02), as well as blood glucose (median 6.0 vs. 1.0, P = 0.01). In our population, the overall MS incidence was low and largely similar in patients who started HAART or remained naive. However, the feature of MS was different in the two groups, suggesting that in untreated and treated patients MS developed through different metabolic pathways

Tenofovir renal safety in HIV-infected patients: results from the SCOLTA project

Objective: To evaluate the prevalence and incidence of nephrotoxicity in HIV-infected patients enrolled in the SCOLTA Project tenofovir cohort and to identify possible risk factors. Design: The SCOLTA Project is a prospective, observational, multicenter study involving 25 infectious disease departments in Italy created to assess the incidence of severe adverse events in patients receiving new antiretroviral drugs. Patients: The SCOLTA Project tenofovir cohort includes a total of 754 HIV infected patients. Results: Data including grade IIeIV creatinine elevations according to ACTG scale were available in 354 patients, 237 (67%) males with a mean age of 40.1 ± 7.6 years enrolled in the SCOLTA Project tenofovir cohort. During a mean follow up of 19.5 ± 11.5 months creatinine elevations were reported in 9/354 (2.5%) patients, all males. Mean duration of tenofovir therapy at the event was 9.5 ± 5 months. The overall incidence was 1.6 (95% CI 1.5e1.7) per 100 person-years (p-y) and 0.5 (95% CI 0.4e0.6) p-y for grade III. No grade IV creatinine elevations were reported. Patients with nephrotoxicity were older and more frequently male, HCV infected, in CDC stage C and their CD4 cell count was significantly lower than those without nephrotoxicity. No significant difference was found between tenofovir co-administered antiretroviral drugs. Conclusions: Both prevalence and incidence of nephrotoxicity were low in patients receiving tenofovir in a non-selected clinical setting. Renal injury in patients receiving tenofovir seems associated with the presence of co-morbidities and with advanced HIV infection

Raltegravir-based therapy in a cohort of HIV/HCV co-infected individuals

The relationship between hepatic tolerance and hepatitis C virus (HCV) co-infection has not been extensively studied in clinical practice. We assessed the efficacy and safety of raltegravir-based therapy in an Italian cohort of HIV/HCV co-infected patients. One hundred and forty patients with HIV/HCV co-infection initiating raltegravir from SCOLTA project (Surveillance Cohort Long-Term Toxicity Antiretrovirals) were examined. Of them, 43 were women, with mean age of 45.4 ± 6.4 years; 65 (46%) had undetectable HIV-RNA &lt; 50 copies/mL and 75 (54%) HIV-RNA ≥ 50 copies/mL. According to CDC classification, 49 (35%) were in stage C. Based on Fib4 score at the time of starting raltegravir, patients were classified in class I in 41 cases, class II in 68 and in class III in 31 cases. Globally, the Fib4 score slightly decreased during 24 months follow-up, from 2.2 to a value of 1.8. Hepatic adverse events of any grade were observed in 67 patients, of which only 2 cases (3%) had severe liver toxicity (grade 3–4). Only one patient had to discontinue the therapy because of adverse events. According to univariate analysis, being in CDC stage C represented a risk for the development of liver toxicity, with a hazard ratio (HR) of 2.27 (95% CI 1.06–4.84, P = 0.033). None of the other variables considered (age, sex, years since detection of HIV and HCV-RNA detectable, years of previous HIV therapy, concomitant therapy with PI or NRTI, CD4+ cell count, Fib4, and transaminases level at baseline) resulted statistically correlated to the outcome. In conclusion, raltegravir-based regimens can be safely used in HCV infected patients; in this study, the hepatic toxicity has been found to be more frequent in patients with an advanced HIV disease (CDC stage C), independently of HIV-RNA suppression at raltegravir initiation