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Luisa Romanò

Publications and source records attributed to Luisa Romanò.

17 recordsLinked to original sources
PubMed2006

Modulation of epitope-specific anti-hepatitis C virus E2 (anti-HCV/E2) antibodies by anti-viral treatment.

The dynamic features of three specific anti-hepatitis C virus (HCV) antibody subpopulations directed against different conformational epitopes of the viral E2 protein (HCV/E2) have been evaluated in patients with primary and persistent HCV infection; the three subpopulations are present in patients infected with different HCV genotypes and have shown a different activity using a pseudovirus neutralization assay (antibodies e301 and e137 exhibiting high neutralizing activity, while antibody e509 enhancement of HCV infectivity). In sequential samples from five patients with primary HCV infection and different virological outcome, all samples tested negative with the single exception of the e509 antibody in a patient not clearing the virus. In sequential samples from 28 patients with persistent infection under treatment with pegylated interferon-alpha plus ribavirin (14 sustained virological responders and 14 non-responders), the therapy did not selectively influence titers of the two neutralizing antibody subpopulations; otherwise, a net increase of the e509 antibody subpopulation related to enhancement of HCV infectivity was observed in non-responders, but not in sustained virological responders (P = 0.0156). This increase was not related to the trend of total anti-HCV/E2 response. The data indicate that a specific antibody response against these epitopes is elicited only late during the infection, thus not influencing virus clearance during primary infection, and that a selective increase of the antibody subpopulation enhancing virus infectivity is observed only in the cohort of patients not responding to antiviral therapy.

5' Untranslated Regions↗
PubMed2006

Changing patterns of hepatitis B infection in Italy and NAT testing for improving the safety of blood supply.

In Italy, as in most industrialized countries, the burden of hepatitis B has progressively declined in recent decades as a consequence of general improvements in hygiene and standard of living, the introduction of several public health measures, refinement in blood screening and the implementation of specific vaccination programmes. Universal hepatitis B vaccination for all infants and adolescents as well as individuals at increased risk has resulted in considerable progress towards prevention and control of HBV infection. The residual risk of transmitting blood-borne viruses through transfusion is currently very low. Nucleic acid testing can shorten the window period and, consequently, further reduce the risk of viral transmission. Blood donor screening for HCV by NAT was initiated in Italy in 2001 and became mandatory in June 2002. NAT for HIV is currently mandatory in four regions, not mandatory but almost universally performed in another thirteen regions, and not yet introduced in the remaining four regions. NAT for HBV is currently mandatory in four regions and under evaluation in the remaining. NAT for HBV may be a useful tool in detecting acute viral infections in the window phase as well as the occult infections. Its efficacy in improving the safety of blood supply is expected to be higher in countries with intermediate/high endemicity, where anti-HBc antibody screening cannot be routinely performed. There is agreement that, at present, the implementation of HBV DNA testing will not allow for discontinuation of screening for HBsAg.

DNA, Viral↗
PubMed2005

Multicenter evaluation of a semiautomated, standardized assay for detection of hepatitis B virus DNA in blood donations.

We evaluated the COBAS Ampliscreen hepatitis B virus (HBV) test using standards, seroconversion panels, consecutive donations, and samples from patients with abnormal alanine aminotransferase and chronic hepatitis C. Specificity was 100% and sensitivity was 20 IU/ml. In seroconversion panels, HBV DNA was detected up to 4 to 18 days before HBsAg, suggesting that this assay is useful in shortening the infectious window phase.

Blood Donors↗
PubMed2004

An economic evaluation of varicella vaccination in Italian adolescents.

An economic evaluation was performed to assess five varicella vaccination scenarios targeted to 11-year-old Italian adolescents. The scenarios were: "compulsory vaccination" of all adolescents, recommended vaccination of susceptible adolescents on the basis of an "anamnestic screening", a "blood test" or a combination of both ("both tests") and vaccination of adolescents in the private sector, at the parents' charge ("private vaccination"). Probabilities and unit costs were taken from published sources and experts opinion. The accuracy of the anamnestic screening (81.6% sensitivity and 87.3% specificity) was derived from a separate descriptive study among 344 Italian adolescents. The costs and benefits of each scenario were simulated using a Markov model and cost-effectiveness, budget-impact and cost-benefit analyses were conducted. Of all considered scenarios, "both tests" and "anamnestic screening" were the most appealing options with an estimated net direct cost of 5058 and 8929 per life-year gained (compared to no vaccination) versus 14,693-42,842 for the other scenarios. These two scenarios further resulted in substantial net savings for society (over 600,000 per cohort, BCR: 2.17). The need for a serological confirmation was highly dependent on the sensitivity of the anamnestic screening, which is believed to increase once such a program is launched. For practical considerations, "anamnestic screening" seems to be the most convenient option.

Adolescent↗
PubMed2004

Detection and quantitation of hepatitis E virus in human faeces by real-time quantitative PCR.

Hepatitis E Virus (HEV) is the causative agent of an acute and self-limited form of hepatitis. The virus is transmitted by the faecal-oral route and is a major cause of viral hepatitis in much of the developing world where it causes sporadic infections and large-scale epidemics. A simple and rapid protocol for the measurement of HEV faecal shedding by a real-time polymerase chain reaction (PCR) with the SYBR Green method on a LightCycler instrument, is described. After only 3h the real-time quantitative PCR method detected 10 molecules of HEV cDNA fragment per reaction tube and showed a high linear dynamic range of quantitation (10-10(6) molecules of cDNA/reaction) with a good correlation (r = -1.00). Its specificity was confirmed by assay in human faecal samples.

Benzothiazoles↗
PubMed2004

Immunogenicity, reactogenicity and adherence with hepatitis A vaccination among drug users.

Hepatitis A virus (HAV) vaccination is recommended in drug users (DUs) because this population has a very high prevalence of hepatitis C virus, and additional infection with HAV can lead to increased morbidity and mortality. The efficacy of hepatitis A vaccine (1440 ELISA units), in terms of immunogenicity, reactogenicity and compliance among 44 heroin DUs using a 0-6 month schedule was investigated. Three subjects (6.8%) experienced adverse reactions. After the first dose of hepatitis A vaccine, 37% of subjects seroconverted. Two months after the 6-month booster vaccination, all vaccinated patients became seropositive. The mean serum antibody concentration was 40 mIU/ml after 6 months and 558 mIU/ml after 8 months. Although all DUs proved seropositive after the booster vaccination, the seroconversion rate, at the 2 and 6 months time points was much lower than in healthy subjects. The lower geometric mean titre could affect the kinetics of decrease of antibody titres and the protection conferred by vaccination may be less durable in these patients. These findings indicate that the 0-12 months schedule could be reduced to a shorter 0-6 months schedule in order to shorten the unprotected period. Further studies among drug users are needed to explore the efficacy and immunogenicity of higher doses or alternative schedules of HAV vaccine.

Adult↗
PubMed2004

Long-term outcome (35 years) of hepatitis C after acquisition of infection through mini transfusions of blood given at birth.

Long-term follow up studies of hepatitis C virus (HCV) infection rarely exceed 20-25 yr. We studied the outcome of HCV infection in 35-yr-old adults infected at birth (1968) through mini transfusions of blood. A retrospective-prospective study was carried out. The cohort included 31 individuals who were given mini blood transfusions (21-30 ml) collected from a donor subsequently revealed to be HCV infected. At enrollment (1998), 18 of 31 (58.1%) recipients had anti-HCV antibody and 16 (88.9%) of them were HCV-RNA positive. All viremic recipients and the infectious donor had the same genotype 1b. Sequence analysis of E1/E2 and NS5b regions, coupled with phylogenetic analysis, indicated that HCV isolates from donor/recipients were linked. Eleven of the 16 viremic recipients gave consent to liver biopsy. Nine had no fibrosis or mild portal fibrosis and 2 had either discrete (Ishak's staging 3) or marked (Ishak's staging 4) fibrosis. During the prospective follow-up period (1998-2003), 2 patients were given therapy, one of whom achieved sustained clinical and virologic response. A second biopsy, performed in 5 patients at a 5 yr interval, revealed no substantial modifications in 4 cases and progression from absence of fibrosis to mild portal fibrosis in the fifth. In conclusion, taking into account the limited study sample, these findings suggest that HCV infection acquired early in life shows a slow progression and mild outcome during the first 35 yr of infection.

Adult↗
PubMed2004

Immunogenicity, reactogenicity and adherence to a combined hepatitis A and B vaccine in illicit drug users.

AIMS: The use of illegal drugs is associated with an increase in infective risk for the hepatitis viruses, against which the vaccination of drug users (DUs) is recommended unanimously. The aim of the study was to determine tolerability, adherence and immune response of a combined vaccine providing dual protection against hepatitis A virus (HAV) and hepatitis B virus (HBV). METHODS: The vaccine was administered to 38 DU, attending three public health centres for drug users in northern Italy, with a three-dose schedule (at 0, 1 and 6 months). The vaccine was well tolerated: only one adverse reaction (fever) was recorded after the 110 doses administered (0.9%). The vaccine schedule was completed successfully in 35 cases (92.1%). At month 8, in 34 subjects (89.5%) antibody response was evaluated: all showed seroprotection for HAV and in 33 subjects (97.1%) for HBV. CONCLUSIONS: The vaccine, studied for the first time in DUs, proved to be safe, well accepted and immunogenic; anti-HAV response was 1272 mIU/ml and 1726 mIU/ml for anti-HBV, titres lower than reported in literature for the general population. This study suggests that DUs who are HAV/HBV-negative could be vaccinated with combined vaccine.

Adult↗
PubMed2004

Lack of evidence of sexual transmission of hepatitis C among monogamous couples: results of a 10-year prospective follow-up study.

The risk of sexual transmission of hepatitis C virus (HCV) infection was evaluated among 895 monogamous heterosexual partners of HCV chronically infected individuals in a long-term prospective study, which provided a follow-up period of 8,060 person-years. Seven hundred and seventy-six (86.7%) spouses were followed for 10 yr, corresponding to 7,760 person-years of observation. One hundred and nineteen (13.3%) spouses (69 whose infected partners cleared the virus following treatment and 50 who ended their relationship or were lost at follow-up) contributed an additional 300 person-years. All couples denied practicing anal intercourse or sex during menstruation, as well as condom use. The average weekly rate of sexual intercourse was 1.8. Three HCV infections were observed during follow-up corresponding to an incidence rate of 0.37 per 1,000 person-years. However, the infecting HCV genotype in one spouse (2a) was different from that of the partner (1b), clearly excluding sexual transmission. The remaining two couples had concordant genotypes, but sequence analysis of the NS5b region of the HCV genome, coupled with phylogenetic analysis showed that the corresponding partners carried different viral isolates, again excluding the possibility of intraspousal transmission of HCV. Our data indicate that the risk of sexual transmission of HCV within heterosexual monogamous couples is extremely low or even null. No general recommendations for condom use seem required for individuals in monogamous partnerships with HCV-infected partners.

Adult↗
PubMed2003

Primary prevention of hepatitis C virus infection.

Viral hepatitis type C is a worldwide public health problem of major concern. Waiting for a safe and effective vaccine able to confer protection to susceptible individuals, public health challenges for controlling hepatitis C require implementation of primary prevention measures that reduce risks of acquiring/transmitting HCV infection. Screening for safe blood and blood products, use of disposable syringes and needles and of universal precautions have dramatically reduced risk of infection in medical setting. Health education, counselling and testing of individuals at risk provide opportunities for controlling HCV infection.

Global Health↗
PubMed2003

Prevalence and clinical significance of circulating cryoglobulins in HIV-positive patients with and without co-infection with hepatitis C virus.

Although hepatitis C virus (HCV) is a recognized cause of circulating cryoglobulins, the role of human immunodeficiency virus (HIV) in the pathogenesis of cryoglobulinemia has not been investigated extensively. To evaluate the prevalence of circulating cryoglobulins and to assess the relationship with clinical and virological parameters, 162 HIV-positive subjects (84 anti-HCV(+)) were tested for cryoglobulins, C3, C4, RF, autoantibodies, HIV-viral titer, and CD4(+) count. Anti-HCV-positive subjects were tested for HCV-RNA, HCV-viral titer, and HCV genotype. All patients were examined for the presence of signs or symptoms of vasculitis and tested for cryoglobulins using a standard biochemical assay. Cryoglobulins were found in 30 (18.5%) cases. Of the 30 positive cases, 29 (96.7%) were anti-HCV-positive and 28 (93.3%) HCV-RNA-positive. The presence of cryoglobulins was significantly associated (P < 0.01) with HCV-RNA positivity (OR = 27), liver cirrhosis (OR = 16), decreased levels of C3 (OR = 8.6), C4 (OR = 13.6), increased levels of IgG and IgM (OR = 6.1 and 7.9, respectively), and RF positivity (OR = 6.3), but was unrelated to CD4(+) cell count, HIV viral load, diagnosis of AIDS, HCV viral load and the presence of autoantibodies. Interestingly, the presence of cryoglobulins was not significantly associated with signs and symptoms commonly associated with cryoglobulinemia. In conclusion, HIV infection does not seem to play a significant role in the production of circulating cryoglobulins, which strongly correlates with HCV co-infection and liver cirrhosis. Typical signs and symptoms of cryoglobulinemia do not correlate with the detection of circulating cryoglobulins in HIV and HCV patients.

Adult↗
PubMed2003

Total HCV core antigen assay: a new marker of hepatitis C viremia for monitoring the progress of therapy.

The ability of the total hepatitis C virus (HCV) core antigen assay was evaluated for monitoring the therapeutic responses of HCV-infected patients treated with interferon. The ability to detect and quantitate an independent structural protein component of HCV, in the presence of circulating antibodies, makes this assay a valuable new tool in diagnosis and treatment monitoring. Measurement of total core antigen showed a strong dynamic correlation with HCV RNA data and may serve as an alternative direct marker of viral infection. In addition, with the advent of additional treatment protocols, a rapid, reliable assay for changes in HCV load may permit more frequent patient assessment and tailoring of the therapeutic regimen.

Biological Assay↗
PubMed2002

Residual risk of transfusion-transmitted HCV and HIV infections by antibody-screened blood in Italy.

BACKGROUND: This study was designed to assess the risk of transmitting HCV and HIV by transfusion of antibody-screened blood and to estimate the additional reduction in risk that may be achieved through the implementation of direct viral detection assays in Italy. STUDY DESIGN AND METHODS: Clinical and laboratory data of 2,411,800 blood donations collected from repeat volunteer donors from 1996 through 2000 were analyzed. The risk of transmitting HCV or HIV from screened blood donated during the window period was estimated using a mathematical model. RESULTS: The residual risk of donating antibody-negative infectious blood was estimated at 1 in 127,000 donations for HCV and 1 in 435,000 for HIV. The use of NAT should further reduce such risk by 83 percent for HCV and 50 percent for HIV. CONCLUSION: The residual risk of HCV or HIV transmission through screened blood is currently very small in Italy. The implementation of direct viral detection assays can further improve the safety of blood supply.

Antibodies, Viral↗
PubMedDate not supplied

Long-term immunogenicity of hepatitis B vaccination and policy for booster: an Italian multicentre study.

BACKGROUND: Universal anti-hepatitis-B vaccination of infants and adolescents was implemented in Italy in 1991. We undertook a multicentre study in previously vaccinated individuals to assess the duration of immunity and need for booster, over 10 years after vaccination. METHODS: In 1212 children and 446 Italian Air Force recruits vaccinated as infants and adolescents, respectively, we measured the concentrations of antibodies to hepatitis-B surface antigen (anti-HBs) and the presence of antibodies to hepatitis-B core antigen (anti-HBc) at enrollment; postimmunisation values were not available. Individuals positive for anti-HBc were tested for hepatitis B surface antigen (HBsAg) and hepatitis B viral DNA. Individuals with anti-HBs concentrations at 10 IU/L or more were regarded as protected; those with antibody less than 10 IU/L were given a booster dose and retested 2 weeks later. Individuals showing postbooster anti-HBs concentrations of less than 10 IU/L were offered two additional vaccine doses and retested 1 month after the third dose. FINDINGS: Protective anti-HBs concentrations were retained in 779 (64%, 95% CI 61.6-67) children and 398 (89%, 86.4-92.1) recruits. We recorded antibody amounts of less than 10 IU/L in 433 children (36%, 33-38.4) and 48 (11%, 7.9-13.6) recruits. One child and four recruits were positive for anti-HBc, but negative for HBsAg and hepatitis B viral DNA. Antibody concentrations were higher in recruits than in children (geometric mean titre 234.8 IU/L vs 32.1 IU/L, p=0.0001). 332 (97%) of 342 children and 46 (96%) of 48 recruits who received a booster showed an anamnestic response, whereas ten (3%) children and two (4%) recruits remained negative for anti-HBs or had antibody concentrations of less than 10 IU/L. Prebooster and postbooster antibody titres were strongly correlated with each other in both groups. All individuals given two additional vaccine doses (eight children and two recruits) showed anti-HBs amounts of more than 10 IU/L at 1 month after vaccination. INTERPRETATION: Strong immunological memory persists more than 10 years after immunisation of infants and adolescents with a primary course of vaccination. Booster doses of vaccine do not seem necessary to ensure long-term protection.

Adult↗
PubMedDate not supplied

[Characterisation of an HBsAg mutant of hepatitis B virus (HBV) isolated from a dialysed patient involved in an occupational accident].

BACKGROUND: Mutants of the hepatitis B virus (HBV) following vaccination (escape mutants) have been isolated over the course of the last decade. They consist most commonly of an aminoacid change from glycine to arginine at position 145 of the highly antigenic a determinant of the surface antigen (HBsAg). OBJECTIVE: Description of an escape mutant of HBV identified in the course of the post-exposure follow-up of a percutaneous exposure. METHODS: The viral DNA was extracted from serum samples of a dialysed patient vaccinated against hepatitis B, who developed an acute infection. A direct sequencing was performed on the amplified DNA followed by a sequence analysis. RESULTS AND CONCLUSIONS: A threonine to lysine substitution at position 118 of HBsAg (Thrll8Lys) was observed in the analysed viral aminoacid sequence. Such mutation could have significantly changed the antigenic profile of the HBsAg compared to that of the wild type.

Accidents, Occupational↗