BACKGROUNDValacyclovir is the only treatment demonstrated to be effective for the prevention of vertical transmission of cytomegalovirus within a clinical randomized, placebo-controlled trial and has ...been reimbursed by the Italian National Health System since December 2020. OBJECTIVEThis study reported the results of a real-life Italian multicenter observational study on cytomegalovirus infection in pregnancy evaluating the effect of the introduction of valacyclovir in the clinical practice for the prevention of vertical transmission of cytomegalovirus. STUDY DESIGNThe outcomes of women who received valacyclovir treatment and their fetuses or newborns were compared with those of a retrospective cohort observed between 2010 and 2020 who did not receive the antiviral treatment. The inclusion criterion was the diagnosis of cytomegalovirus primary infection occurring in the periconceptional period or up to 24 weeks of gestation. The primary outcome was the transmission by the time of amniocentesis. The secondary outcomes were termination of pregnancy, transmission at birth, symptomatic infection at birth, and a composite outcome (termination of pregnancy or transmission at birth). RESULTSA total of 447 pregnant women from 10 centers were enrolled, 205 women treated with valacyclovir (called the valacyclovir group, including 1 twin pregnancy) and 242 women not treated with valacyclovir (called the no-valacyclovir group, including 2 twin pregnancies). Valacyclovir treatment was significantly associated with a reduction of the diagnosis of congenital cytomegalovirus infection by the time of amniocentesis (weighted odds ratio, 0.39; 90% confidence interval, 0.22-0.68; P=.005; relative reduction of 61%), termination of pregnancy (weighted odds ratio, 0.36; 90% confidence interval, 0.17-0.75; P=.0021; relative reduction of 64%), symptomatic congenital cytomegalovirus infection at birth (weighted odds ratio, 0.17; 90% confidence interval, 0.06-0.49; P=.006; relative reduction of 83%). The treatment had no significant effect on the rate of diagnosis of congenital cytomegalovirus infection at birth (weighted odds ratio, 0.85; 90% confidence interval, 0.57-1.26; P=.500), but the composite outcome (termination of pregnancy or diagnosis of congenital cytomegalovirus infection at birth) occurred more frequently in the no-valacyclovir group (weighted odds ratio, 0.62; 90% confidence interval, 0.44-0.88; P=.024). Of note, the only symptomatic newborns with congenital cytomegalovirus infection in the valacyclovir group (n=3) were among those with positive amniocentesis. Moreover, 19 women (9.3%) reported an adverse reaction to valacyclovir treatment, classified as mild in 17 cases and moderate in 2 cases. Lastly, 4 women (1.9%) presented renal toxicity with a slight increase in creatinine level, which was reversible after treatment suspension. CONCLUSIONOur real-life data confirm that valacyclovir significantly reduces the rate of congenital cytomegalovirus diagnosis at the time of amniocentesis with a good tolerability profile and show that the treatment is associated with a reduction of termination of pregnancy and symptomatic congenital cytomegalovirus infection at birth.
We report miscarriage following dengue virus (DENV)-3 infection in a pregnant woman returning from Bali to Italy in April 2016. On her arrival, the woman had fever, rash, asthenia and headache. DENV ...RNA was detected in plasma and urine samples collected the following day. Six days after symptom onset, she had a miscarriage. DENV RNA was detected in fetal material, but in utero fetal infection cannot be demonstrated due to possible contamination by maternal blood.
Severe imported pediatric malaria is of concern in non-endemic settings. We aimed to determine the features of pediatric severe cases in order to design a model able to stratify patients at ...presentation.
We conducted a retrospective cross-sectional study including all imported P. falciparum malaria infection in patients ≤14 years of age, treated from January 2008 to February 2019 in two tertiary hospitals: Brescia, Italy and Barcelona, Spain. Severe malaria was defined according to World Health Organization criteria. Mortality rate, pediatric intensive care unit (PICU) stay and blood transfusion were analysed as adverse outcomes.
Out of 139 children included, 30.9% were severe malaria. Twenty-seven (19.4%) were admitted to PICU, and transfusion was required in 14 cases (10.1%). Predictors for severe malaria were: young age, low hemoglobin, high white blood cells (WBC) and high C-reactive protein. Platelet <130,000/μl correlated with severe malaria (without statistical significance). A model that includes age, WBC and C-reactive protein shows a high specificity to classify patients without severe malaria (92.3%) with 70% PPV and 75% NPV.
A score based on patient's age, WBC and C-reactive protein easily available at emergency room can help to identify children with higher risk of adverse outcomes.
Valacyclovir (VCV) is the only treatment demonstrated to be effective for prevention of vertical transmission of Cytomegalovirus (CMV) within a clinical randomized, placebo controlled, trial and is ...reimbursed by the Italian National System since 2020.
We report the results of a real-life Italian multicenter observational study (MEGAL-ITALI) on CMV infection in pregnancy evaluating the impact of the introduction of VCV in the clinical practice for the prevention of vertical transmission of CMV.
The outcomes of women who received VCV treatment and their fetuses / newborns were compared with those of a retrospective cohort observed between 2010 and 2019 who did not receive the antiviral treatment. Inclusion criteria was diagnosis of CMV primary infection occurring in the periconceptional period or up to 24 weeks gestation. Primary outcome was the transmission by the time of amniocentesis. Secondary outcomes were termination of pregnancy, transmission at birth, symptomatic infection at birth, and a composite outcome (termination of pregnancy or transmission at birth).
447 pregnant women from 10 centers were enrolled, 205 treated with valacyclovir (called VCV group, including one twin pregnancy) and 242 untreated (including two twin pregnancies, called no-VCV group). VCV treatment was significantly associated with reduction of cCMV diagnosis by the time of amniocentesis (weighted odds ratio, OR, 0.39, 90% CI, 0.22-0.68; p = 0.005, relative reduction 61%), termination of pregnancy (weighted OR, 0.36, 90% CI, 0.17-0.75; p = 0.0021, relative reduction 64%), symptomatic cCMV infection at birth (weighted OR, 0.17, 90% CI, 0.06-0.49; p = 0.006, relative reduction 83%). The treatment had no significant effect on the rate of cCMV diagnosis at birth (weighted OR, 0.85, 90% CI, 0.57-1.26; p = 0.500), but the composite outcome (termination of pregnancy or diagnosis of cCMV at birth) occurred more frequently in the no VCV group (weighted OR, 0.62, 90% C, 0.44-0.88; p=0.024) Of note, the three symptomatic newborns with cCMV in the VCV group were among those with positive amniocentesis. Nineteen women (9.3%) complained an adverse reaction to valacyclovir treatment classified as mild in 17 cases and moderate in 2 cases. Four women presented renal toxicity (1.9%) with a slight increase of creatinine, reversible after treatment suspension.
Our real-life data confirms that valacyclovir significantly reduces the cCMV rate at the time of amniocentesis with a good tolerability profile and shows that the treatment is associated with reduction of termination of pregnancy and symptomatic cCMV at birth.
The protective role of Sickle Cell Trait (SCT) in malaria endemic areas has been proved, and prevalence of HbS gene in malaria endemic areas is high. Splenic infarction is a well-known complication ...of SCT, while the association with malaria is considered rare. A Nigerian boy was admitted to our ward after returning from his country of origin, for
malaria. He underwent abdominal ultrasound for upper right abdominal pain, showing cholecystitis and multiple splenic lesions suggestive of abscesses. Empiric antibiotic therapy was undertaken.
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serologies, blood cultures, Quantiferon test, copro-parasitologic exam were negative; endocarditis was excluded. He underwent further blood exams and abdomen MRI, confirming the presence of signal alterations areas, with radiographic appearance of recent post-infarction outcomes. Hemoglobin electrophoresis showed a percentage of HbS of 40.6% and a diagnosis of SCT was then made. Splenic infarction should be taken into account in patients with malaria and localized abdominal pain. Moreover, diagnosis of SCT should be considered.
A total of 204 patients with liver biopsy—proven hepatitis C virus (HCV) infection, 84 with and 120 without human immunodeficiency virus (HIV) coinfection, were studied, to evaluate variables ...possibly associated with the stage of liver fibrosis. All patients were injection drugs users, with a mean age of 32 years and an estimated duration of HCV infection of 12 years. Twenty-four patients (11%) had many fibrous septa with (5%) or without (6%) cirrhosis, 56 (27%) had few fibrous septa, and 124 (60%) had no fibrous septa. In all patients, an association was found between CD4 cell counts <500 cells/mm3and the presence of many fibrous septa (odds ratio, 3.2; P = .037), independent of HIV infection and other factors. These results suggest that HIV infection-induced CD4 depletion is independently associated with the severity of liver fibrosis in chronic HCV infection.
To assess incidence, risk factors, histology, and outcome of severe hepatotoxicity (SH) during antiretroviral treatment (ART).
Seven hundred fifty-five HIV-seropositive patients consecutively ...prescribed new ART were selected. Liver function tests were assessed at baseline, after 1 month, and every 4 months thereafter. Liver biopsy was recommended in case of SH (i.e., increase in liver enzymes >/=10 times the upper limit of normal or 5 times baseline if markedly abnormal).
Twenty-six cases of SH were observed with an incidence of 4.2% person-years. Liver failure (LF) was rarely seen (1.1 per 100 person-years). Liver damage was invariably observed in patients with chronic viral hepatitis. Liver histology showed exacerbation of viral hepatitis in all 16 patients for whom a liver biopsy was available at the time of SH. A direct correlation was found between alanine aminotransferase increase and increase in CD4 T-cell count in patients with SH (r = 0.53, p <.001). Death occurred during follow-up in 7 of 26 (27%) patients, all of whom showed LF and baseline CD4+ count less than 200 cells/mm(3) (7/7 patients = 100% vs. 8/19 patients without LF; p <.01). Relapse of SH was observed after ART was recommenced in 7 of 17 (41%) patients. Five of these 7 patients did not show further SH relapse after treatment with interferon.
This study provides estimates of SH and LF in a large population-based setting where hepatitis C virus coinfection is highly prevalent and provides indications that liver damage may be caused by immune reconstitution and related exacerbation of viral hepatitis. A strict follow-up for hepatotoxicity is mandatory when ART is initiated in patients with <200 CD4+ T cells/mm(3). Antihepatitis pre- or comedication could be an effective preventive or curative measure.
Severe imported malaria is an important problem in European countries, where approximately 8,000 cases of Plasmodium falciparum malaria are reported each year. Although the World Health Organization ...recommends intravenous artesunate (IVA) as the treatment of choice for severe malaria in areas of low transmission, it is rarely used in Europe, because it is not yet available as a drug manufactured under Good Manufacturing Practices. We report a series of eight imported severe falciparum malaria cases treated with IVA combined with intravenous quinine (IVQ). This combined therapy was found to be efficacious, safe, and well-tolerated. The only observed death occurred in a young man who presented 10 days after the onset of symptoms. IVA plus IVQ treatment seems to be an acceptable approach, because the legal risks in using an unlicensed drug for treating a severe malaria case denies the patient the possibility of being treated with the most effective regimen.