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In 2012, we conducted a retrospective cross-sectional study to assess the number of people living with HIV linked to care and, among these, the number of people on antiretroviral therapy. The health authority in each of the 20 Italian Regions provided the list of Public Infectious Diseases Clinics providing antiretroviral therapy and monitoring people with HIV infection. We asked every Public Infectious Diseases Clinic to report the number of HIV-positive people diagnosed and linked to care and the number of those on antiretroviral therapy during 2012. In 2012, 94,146 people diagnosed with HIV and linked to care were reported. The majority were males (70.1%), Italians (84.4%), and aged between 25 and 49 years (63.4%); the probable route of transmission was heterosexual contact in 37.5% of cases, injecting drug use in 28.1%, and male-to-male contact in 27.9%. Among people in care, 20.1% had less than 350 CD4 cells/μl, 87.6% received antiretroviral therapy, and among these, 62.4% had a CD4 cell count higher than 350 cells/μl. The overall estimated prevalence of individuals diagnosed and linked to care in 2012 in Italy was 0.16 per 100 residents (all ages). Adding the estimated proportion of undiagnosed people, the estimated HIV prevalence would range between 0.19 and 0.26 per 100 residents. In Italy, the majority of people diagnosed and linked to care receive antiretroviral therapy. A higher prevalence of individuals diagnosed and linked to care was observed in Northern Italy and among males. More information for developing the HIV care continuum is necessary to improve the entire engagement in care, focusing on test-and-treat strategies to substantially reduce the proportion of people still undiagnosed or with a detectable viral load.

Objectives To evaluate temporal trends of Kaposi's sarcoma (KS) and of the KS-related human herpesvirus (HHV-8) among homosexual men who seroconverted for HIV between 1984 and 1997. Methods The study participants were 387 homosexual men. Changes over a period of time were assessed by estimating KS incidence rates per 1000 person-years for the periods 1984-1989, 1990-1992, 1993-1995, and 1996-1997. The proportional incidence of KS as the AIDS-defining disease for the same periods was also calculated. To evaluate a cohort effect of calendar period, Kaplan-Meier curves were used to estimate the risk of KS by period of HIV seroconversion [i.e. before 1990 (median year of seroconversion) versus later]. Relative hazards for the four periods were estimated using competitive-risks models. We also estimated HHV-8 seroprevalence over the study period. Results Forty-eight participants developed KS. Between 1984 and 1995, the incidence rate of KS per 1000 person-years increased from 3.9 to 32.8, whereas the proportional incidence decreased from 33.3 to 24.3%. The risk of developing KS after HIV seroconversion did not change when comparing the seroconversion periods (i.e. before 1990 versus later). HHV-8 seroprevalence also remained stable. The rates of KS and the relative hazards dramatically decreased after 1995. Conclusions Although KS incidence rates increased up to 1995, the proportional incidence decreased, due to the higher increase in rates of other AIDS-defining diseases. The finding that the risk of developing KS after HIV seroconversion remained stable over time is consistent with the stable trend of HHV-8 seroprevalence. The dramatic decrease in KS incidence rates after 1995 coincides with combined antiretroviral therapy.

Objectives: To evaluate if different levels of human herpesvirus 6 (HHV-6) antibodies can predict HIV disease progression. Design: Longitudinal study of individuals with a documented date of HIV seroconversion. Setting: Clinical centers located throughout Italy. Patients: Individuals who serconverted for HIV between 1983 and 1995 in Italy. Methods: Sera were tested for IgG antibodies to HHV-6 using a commercial enzyme immunoassay. A serum sample with an optical density (OD) ≥ 242 (i.e. the mean value of 10 negative controls+ 4×standard deviation) was considered as HHV-6 positive; the progression of HIV disease was evaluated estimating the relative hazards (RH) of AIDS (by Cox models) for individuals with higher levels vs. lower levels of HHV-6 antibodies or considering levels of antibodies based on 10% increase of the distribution (deciles). Rates of CD4 decline fitting linear regression were also estimated. Results: A total of 381 persons were followed for a median time of 4 years (range: 0.15–9 years) following the date of collection of the serum sample. The median OD value of HHV-6 antibodies was 306, with an interquartile range of 241–440 and a range of 48–2330. A slight inverse correlation was found between HHV-6 antibody levels and age of the individual at the time of serum collection (Spearman rank correlation coefficient, −0.16; p = 0.0013). No association was found between HHV-6 and CD4 level or between HHV-6 and CD8 level at the date of serum collection. The unadjusted RH of progression to AIDS was 0.63 (95% CI: 0.42–0.96) for HHV-6 positive individuals vs. HHV-6 negative; when adjusting for possible confounders (CD4, age, pre-AIDS HIV-related pathologies at the date of sera collection, and previous anti-herpes treatment), the RH of AIDS increased to 0.80 (95% CI: 0.51–1.23). No particular association with HIV disease progression was found when using the deciles of the distribution of HHV-6 antibodies. The median CD4 cell loss was 5.0 × 106 cells/l per month among HHV-6 positive individuals and 5.7 × 106 cells/l per month among the others. Conclusions: The presence of high levels of HHV-6 antibodies does not seem to predict the clinical or immunologic progression of HIV disease.

As the risk of tenofovir-associated renal toxicity has been found to be proportional to the drug plasma concentration, our aim was to measure the determinants of tenofovir plasma exposure in HIV-positive patients with normal renal function. A cross-sectional analysis was conducted in HIV-positive patients chronically receiving tenofovir-containing highly active antiretroviral therapies (HAARTs). Patients on tenofovir-containing antiretroviral regimens, presenting 22 to 26 h after drug intake, having estimated glomerular filtration rates above 60 ml/min, reporting high adherence to antiretroviral medications (above 95% of the doses), and signing a written informed consent were included. Plasma tenofovir concentrations were measured through a validated high-performance liquid chromatography–mass spectrometry (HPLC/LC-MS) method. The tenofovir trough concentrations in 195 patients (median, 50 ng/ml, and interquartile range, 35 to 77 ng/ml) were significantly associated with the estimated glomerular filtration rate, body mass index, and third-drug class (protease-containing versus protease-sparing regimens) (with the highest exposure in unboosted-atazanavir recipients). The results of multivariate analysis showed that the third-drug class and the weight/creatinine ratio were independent predictors of tenofovir trough concentrations. This cross-sectional study shows that tenofovir trough concentrations are predicted by the weight/creatinine ratio and by the coadministered antiretrovirals, with protease inhibitors (whether boosted or unboosted) being associated with the highest plasma exposure. These data, previously available in healthy subjects or for some drugs only, could be useful for designing strategies to manage tenofovir-associated toxicity, since this toxicity has been reported to be dose dependent.

To evaluate if different levels of human herpesvirus 6 (HHV-6) antibodies can predict HIV disease progression.Longitudinal study of individuals with a documented date of HIV seroconversion.Clinical centers located throughout Italy.Individuals who serconverted for HIV between 1983 and 1995 in Italy.Sera were tested for IgG antibodies to HHV-6 using a commercial enzyme immunoassay. A serum sample with an optical density (OD)or =242 (i.e. the mean value of 10 negative controls +4x standard deviation) was considered as HHV-6 positive; the progression of HIV disease was evaluated estimating the relative hazards (RH) of AIDS (by Cox models) for individuals with higher levels vs. lower levels of HHV-6 antibodies or considering levels of antibodies based on 10% increase of the distribution (deciles). Rates of CD4 decline fitting linear regression were also estimated.A total of 381 persons were followed for a median time of 4 years (range: 0.15-9 years) following the date of collection of the serum sample. The median OD value of HHV-6 antibodies was 306, with an interquartile range of 241-440 and a range of 48-2330. A slight inverse correlation was found between HHV-6 antibody levels and age of the individual at the time of serum collection (Spearman rank correlation coefficient, -0.16; p = 0.0013). No association was found between HHV-6 and CD4 level or between HHV-6 and CD8 level at the date of serum collection. The unadjusted RH of progression to AIDS was 0.63 (95% CI: 0.42-0.96) for HHV-6 positive individuals vs. HHV-6 negative; when adjusting for possible confounders (CD4, age, pre-AIDS HIV-related pathologies at the date of sera collection, and previous anti-herpes treatment), the RH of AIDS increased to 0.80 (95% CI: 0.51-1.23). No particular association with HIV disease progression was found when using the deciles of the distribution of HHV-6 antibodies. The median CD4 cell loss was 5.0x10(6) cells/l per month among HHV-6 positive individuals and 5.7x10(6) cells/l per month among the others.The presence of high levels of HHV-6 antibodies does not seem to predict the clinical or immunologic progression of HIV disease.

A multicentre cohort study was conducted in Italy to estimate the risk of developing AIDS in 261 intravenous drug users and 89 homosexual males for whom the seroconversion period was known. Four years after HIV seroconversion, AIDS incidence, estimated by Kaplan-Meier survival technique, was 13.8% for intravenous drug users and 16.2% for homosexual males; the difference was not statistically significant. These findings suggest that four years after seroconversion the risk of developing AIDS in HIV seropositive intravenous drug users is no higher than that of subjects who acquired HIV infection through sexual contact.

The influence of hepatitis B virus (HBV) on the natural history of human immunodeficiency virus (HIV) infection was evaluated in a prospective study of 347 HIV-positive, AIDS-free individuals infected through injecting drug use and sex and with known seroconversion dates. End points were CD4+ cell count < 200 x 10(6) cell/L and AIDS diagnosis. At entry, 229 had seromarkers to HBV; during the study, 107 had a CD4+ cell count < 200 x 10(6) cells/L and 66 developed AIDS. HBsAg chronic carriers, HBV infection-free subjects and those with baseline evidence of prior HBV infection did not differ in rates of progression to end points. Sexual transmission of HIV was significant predictor of CD4+ cell decline to < 200 x 10(6) cells/l [Hazard ratio (HZ): 1.56, 95% confidence interval (CI): 1.06-2.29, p = 0.0232] and progression to AIDS (HZ: 1.91, CI: 1.17-3.11, p = 0.0091). 15 HIV-positive and HBV infection-free patients had HBV seroconversion. They did not differ from those who remained HBV infection-free in rates of progression to end points, but 40% of them became HBsAg chronic carriers. These results suggest that HBV has no influence on progression of HIV disease, but that patients who have HIV before their HBV infection are more likely to become HBsAg chronic carriers than those who are infected with HBV before HIV.

Background HIV infection is a complex medical problem that requires careful monitoring of adherence to treatment, efficacy, development of resistances and toxicities. The estimated life expectancy of patients is increasing, this makes it necessary to find efficient ways to optimise switching therapy away from HAART in order to reduce costs and increase its efficacy. At Amedeo di Savoia Hospital of Turin, the regional centre in Piedmont for HIV infection diagnosis and treatment, hospital pharmacists work in a multidisciplinary team with infectiologists, nurses, psychologists and dieticians. The team follows every aspect of the clinical pathway, leading to an improvement in the clinical management of HIV patients. Purpose To monitor HAART for all patients on therapy To identify patients with a switch of therapy To create a multidisciplinary database including adherence, economic and clinical data before and after the switch To monitor the distribution of available resources in relation with virological outcome and adherence response of patients To achieve a rational use of resources Materials and Methods Collecting data from Oliamm Software and File F using a specific software application, we analysed cost and adherence by the pharmacy refill method (days supplies between refill dates/duration of dispensed therapy x 100) for each switch of treatment between March 2010 and March 2012. From clinical reports we also evaluated the reasons for switching (toxicity, simplification, treatment failure) and the success of variation in term of virological outcome. Results Switching of antiretroviral treatments occured in 250 patients (male 177, female 73, median age 48 years), out of about 1,835 HIV-positive people in treatment, considering overall 310 switches (about 8% at the patient’s request). In 151 cases the switch led to a financial saving and in 159 cases to an increase in cost, leading overall to an excess of cost of 4396,6€ each month (an additional €17,59 for each patient for each month). The reasons for the variation were: treatment failure in 30%, simplification of the treatment in 20%, toxicity in 44% and other causes in 6%. Focus on simplification evidenced: 13% decrease in pill burden, 17% on STR, 55% on LDR, 10% on QD therapy. We also analysed the causes of toxicities. From our study we observed an increased number of patients with suppressed viral load (from 60% to 77%) as evidence of efficacy. 67 out of 125 patients (54%) with pre-switch viral load non-suppressed, had a suppression after switch. 172 patients out of 185 patients (93%) with pre switch viral load suppressed, conserved suppression after switch, but 13 patients (7%) had viral rebound. The change of the treatment didn’t impact on adherence in 50.32% cases and produced an improvement in adherence in 39.03% of switched patients. Only in 10.65% did a decrease of adherence improve. We have also analysed the cost distribution, observing a better use of resources to obtain a viral load under 20 cp/ml and a financial saving for treatment of patients already suppressed pre-switch. Conclusions In our study an analysis of switching treatment has demonstrated a correct distribution of budget and an improvement in adherence. It has also demonstrated the importance of working in team for better management of the therapeutic path. No conflict of interest.

The Italian Cooperative Group on AIDSTumors (GICAT) is collecting data on the epidemiological and clinical features of Kaposi's sarcoma (KS) in Italy, a country where intravenous drug users (IVDUs) comprise the largest group affected by AIDS. As of December 31st 1989, among 5317 cases of CDC-defined AIDS reported to the National Registry of AIDS, there were 419 (8%) cases of KS. Twenty-five percent of all of the homosexual men with CDC-defined AIDS had KS, while only 3% of the IVDU patients with CDC-defined AIDS had KS. The first case of KS was observed in 1982, 2 cases in 1983, 7 cases in 1984, 17 cases in 1985, 55 cases in 1986, 89 cases in 1987, 120 cases in 1988 and 128 cases in 1989. Of the 226 cases of KS reported to GICAT, 60% were in homosexual men, 21% in IVDUs, and 9% in heterosexuals. An increased number of KS has been observed since 1982, although the number of new cases in the past year seems to have been stable, possibly due to the usual delay in notification. There is, however, an actual decrease of the percentage of KS among AIDS patients, from 18% in 1984 to 6% in 1989. Almost half of the patients had had a diagnosis of AIDS prior to the appearance of KS, but in 25% of the patients KS was the first AIDS manifestation. Almost all patients had skin involvement either alone or in association with other sites, whereas very few patients had only lymph node involvement. Only treatment with alpha-2 interferon was able to obtain complete remission in 9% of evaluable patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Objective To identify how reliably CD4+ (helper) lymphocyte count and p24 antigenaemia can predict mother-to-infant transmission of human immunodeficiency virus type 1 (HIV-1). Design Prospective study. Setting University of Turin Center for Intravenous Drug Users (IVDU) and/or HIV-1 seropositive pregnant women. Subjects Twenty-nine infants born to asymptomatic seropositive women from November 1985 to June 1991. Results Seven children (24%) developed symptomatic infection, while 22 healthy seronegative children at the age of 18 months were considered uninfected. A CD4+ lymphocyte count persistently

The pharmacokinetics of kanendomycin, a new aminoglycoside derived from kanamycin, has been assessed in 15 volunteers after i.m. administration of 100 and 300 mg and i.v. administration of 100 mg. Analysis of the tricompartmental model adopted for the pharmacokinetic study showed that kanendomycin half-life is similar and perhaps superior to that of gentamycin. The antibiotic's bioavailability is of the order of 70-80% of the dose used.

The results of a pharmacokinetic and clinical study of cephamandol naphate indicated that the drug quickly reaches high plasma concentration after both i.m. and i.v. bolus administration. Urinary excretion of the biologically active form is as much as 84--90% of the total dose and mostly takes place in the first 6 hr. The therapeutic response was good: clinical cure in 90%, marked improvement in 6.6%, no change in 3.3%.

Following a short review of the viruses underlying viral hepatitis and those which, as a secondary factory in the clinical picture, may cause fleeting liver damge, the subdivision of chronic hepatitis conditions on histopathological bases is described. Particular attention is paid to pathogenesis, with a study of the elimination of B virus, correlated to particular histopathological types. A series of 27 PCH and 49 ACH cases is reported. Of special significance was the observation of 14 ACH out of 17 biopsied drug addicts. The therapeutic problem of chronic hepatitis is then tackled.

Clinical research was conducted to evaluate the comparative therapeutic efficacy in respiratory pathology of 800 mg X 2 per diem bacampicillin v. 1000 mg X 2 per diem amoxicillin, both orally administered. The results were more or less identical and are interpreted as indicating the better constant absorption of the precursor, hence its higher concentration gradient that produces a higher antibiotic concentration in the lungs.

Urinary enzyme excretion was studied in 56 patients treated with cephalosporins in order to evaluate their potential nephrotoxicity. Only in 4 out of 56 patients (7%) was increased NAG, gamma-GT, AlP excretion seen. A rapid return to normal values was observed just after the end of the therapy.

A microbiological and clinical study of the action of piperacillin is presented. The drug showed an excellent in vitro antibacterial action on gram positive and gram negative microorganisms. Its in vitro action on Ps. aeruginosa (70.8% of strains inhibited) was also extremely interesting, making it the second most effective of the antibiotics tested after polymyxin B and colistin, polypeptides unsuitable for clinical use. In vivo, the administration of piperacillin achieved a clinical and bacteriological cure in 35 out of 40 patients and a clinical cure in 2 out of 40. It was only therapeutically unsuccessful in 3 cases. It is concluded that its microbiological, kinetic and tolerance features make piperacillin suitable for a wide range of therapeutic purposes.

Six cases of leptospirosis from the outer suburbs of province of Turin are presented. Some epidemiological aspects are considered, and reference is made to the need for early diagnosis, along with prompt antibiotic management to ensure successful resolution. Mention is also made of the need for careful control of renal function, since its impairment is the most serious complication associated with leptospirosis.

A study was conducted on hospital infections in an emergency surgery ward. The survey lasted one year and confirmed the higher incidence of infections after contaminated and dirty operations. Rates of infection were also high after clean operations due to the large number of subjects at risk among the group examined. The most commonly encountered micro-organisms in the infections of surgical wounds were, in order, E. coli, Str. faecalis and Staph. aureus, the latter being only minimally responsive to the standard antibiotics. Several proposals are advanced for prophylaxis in the attempt to halt the circulation of strains with a multiple resistance to antibiotics.

Following a review of the latest methods of treating infections of the urinary ways, the pharmacokinetic and clinical results of a new antibiotic, Carfecillin, are reported. The examination was carried out on a total of 10 volunteers. The substance showed good serum levels and fair renal excretion with both the 250 mg and the 500 mg p.o. doses. The clinical study was carried out on a double blind basis versus a standard reference (indanyl ester of carbenicillin) in 26 patients and showed the electivity of the antibiotic in the oral treatment of urinary infections under well tolerated conditions.

The literature regarding chemotherapy of cervico-facial tumours is reviewed. Owing to its modest, short-lived results intra-arterial treatment has been largely abandoned even in the case of serious complications. It is only used in selected cases as a preparation for subsequent surgical and/or radiation therapy. General, one-drug cytostatic therapy has been given fair results with objective remissions varying from 7.5 to 58%. In recent years polychemotherapy has proved more effective with remissions of from 30 to 80%. There are too few data on the polychemotherapy-immunotherapy association to draw valid conclusions.

A combined kinetic and clinical study showed that rifampicin displays good tissue diffusibility, though it may have a tendency to accumulate. A liquor transfer sufficient for the bacteria most commonly responsible for meningeal inflammation was observed; 15/18 cases of purulent bacterial meningitis treated were clinically cured without sequelae, while 1 displayed considerable improvement. Two patients died from unforseen, uncontrollable complications that were not related to administration of the drug.

The authors have evaluated general immunocompetence of 10 pts. after a cryosurgery treatment for oral squamous cell carcinoma. Serum immunoglobulin levels, C3 - C4, peripheral lymphocytes, E-rosette forming cells, lymphocyte response to PHA were analized before and after 7 and 14 days a single cryotreatment. Humoral immunity was scarcely modified by the cryosurgery; on the contrary a statistically significant augment of peripheral large lymphocytes (p0,0001), T-lymphocytes (p0,025) and lymphocyte response to PHA (p0,001) was found both after 7 and 14 days.

An investigation conducted on healthy volunteers showed that cefoxitin quickly reaches high plasma concentrations, and is almost completely excreted via the urine within 6 hours. In a series of 21 cases treated with 2 g i.v. in 100 ml of a 5% glucose solution two or three times a day, a clinical cure was achieved in 20, and marked improvement in the remaining patient.

Microbiological, kinetic and clinical studies were conducted on a new cephamycin, cephotetan. In vitro the antibiotic was found to be very effective against all strains tested. It had a particularly strong action against Gram negative bacteria too. Kinetically speaking, an intravenous bolus produced a high plasmatic concentration with a half life of about 4 hours. Elimination via the kidneys was fastest in the first 3 hours after administration (49.82%) and the slowed down. 82.76% of the dose administered was excreted within 24 hours. This antibiotics is particularly indicated in cases of urinary, respiratory and biliary infections.

In vitro cefoperazone proved more active against the tested gram-negative bacteria than either piperacillin or mezlocillin. When administered in 1 g venous bolus the antibiotic achieved high plasmatic concentrations that were still adequate after 8 hours. 33.2% was excreted by the kidneys and a considerable amount by the biliary way. Cefoperazone produced a clinical cure in 35/36 patients (97.22%). A disulfiram-like effect was noted in 18.18%.

A mean plasma concentration curve, with peaks within the first hour and moderate individual variations, was obtained after a single administration of 800 mg of bacampicillin to 5 healthy volunteers. An adequate antibiotic transfer from the circulation to the bronchial apparatus was demonstrated. Treatment of 34 patients suffering from ampicillin-sensitive bacterial diseases permitted clinical cure of all patients, without onset of side-effects. It is concluded that bacampicillin is preferable to oral ampicillin because of its kinetic and tolerance features.

The therapeutic effect of stepronin in 5% glucosate solution has been evaluated in 55/110 viral hepatitis cases (10/55 of A type, 37/55 of B type and 8/55 of nA type nB type), versus other cases (8/55 of A type, 40/55 of B type of 7/55 of nA nB type), treated with 5% glucose solution only. In 18/110 viral hepatitis case of A type, final results with the two different therapies have not shown statistically significantly changes and were comparable. Particularly favourable, in the patients treated, the results obtained in viral hepatitis of B type and nA nB type, were very significant statistically at the end of therapy. In particular, the 2 transaminasic activities had a beneficial influence. Tolerance was very good: only in there cases nettlerash was observed and therapy interrupted in one patient. Therefore the validity of this sulphydryl pro-drug in the treatment of acute viral hepatitis of B and nA and nB type is confirmed.

The results of infection surveillance in orthopaedics are reported: the high incidence of hospital infections in patients undergoing major surgery, the paucity of microbiological data and the failure to standardise prophylaxis protocols were the most significant findings as well as providing a point of departure for programming future fields of intervention and for redefining the operating framework for continuous infection surveillance.

Kinetic and clinical evaluation of cefotiam, a new cephalosporin, is reported. It was found that the drug is rapidly distributed to the tissues. Equilibrium between tissues and plasma is reached in about an hour. Some 90-91% of the dose administered is excreted in the urine, and accumulation does not occur. A clinical cure was obtained in 27 of a series of 35 patients (77.1%). Improvement was observed in 7 cases (20%). The antibiotic proved ineffective in the remaining cases (2.8%). Tolerance was excellent and there were no side-effects worthy of note.

An association of cyclophosphamide, fluorouracil and methotrexate already employed with success against solid tumours in other sites was used in the treatment of 62 patients with advanced tumours of the head and neck. Complete (40.32%) and partial (43.55%) regressions were obtained relatively quickly. A satisfactory period of remission occurred in patients for whom no further treatment had seemed possible, either on account of the extent of the disease, or because surgery and/or radiotherapy had already been performed.

CGP 9000 (cefroxadine), a new cephalosporine derived from N-acyl-3-alkoxy-7-amino-3-cefem-4-carboxylic acid for exclusively oral use, has been experimented on 67 patients, 41 adults and 20 children. CGP 9000 appeared to possess good therapeutic activity, even in low doses: its rapid absorption and moderate sero-protein bond are a guarantee of an immediate and almost total bioavailability.

After a brief review of the data on cefotiam in the literature the report presents the results of microbiological research, a preliminary study into the drug's possible actions on phagocytosis and a polycentric clinical study of 93 cases of broncho-pleuro-pulmonary pathology and one sinusitis of the jaw. In vitro cefotiam was found to have an excellent inhibitory effect on gram positive and gram negative bacteria with MICs50 and 90 respectively 0.2 and 0.8 mcg/ml V. Staph. aureus, Str. pyogenes. E. Coli, K. pneumoniae and Pr. mirabilis. A dose-dependent increase in phagocytosis was noted. The clinical response was excellent with 90.43% (88/94) of the cases achieving clinical and radiological cure or very much improved. Cefotiam was very well tolerated with the appearance of 2/94 skin rashes (2.12%). The liver and kidney parameters showed no change at the end of treatment. No increase in enzymuria was noted during treatment with cefotiam.

Three hundred and forty-four patients at risk for HTLV/LAV infection were examined and seventy-seven were positive at the HTLV III/LAV Ab test. The clinical and laboratory study permitted to diagnose one case of AIDS, 26 cases of ARC and 50 cases of simple positivity at the HTLV III/LAV Ab test.

The role of mutations in protease (PR) and reverse-transcriptase (RT) of human immunodeficiency virus (HIV) in predicting virologic failure was assessed in 248 antiretroviral-naive HIV-positive patients who began a PR inhibitor-containing antiretroviral regimen. Genotypic testing was performed on plasma samples stored before the start of therapy. Twenty-seven patients (10.9%) had mutations in the RT, 5 (2%) carried primary mutations in the PR, and 131 (52.8%) showed only secondary PR mutations. Virologic failure at week 24 occurred in 62 (25.0%) of 248 patients. There was a statistically significant correlation between virologic failure and the number of PR mutations (P= .04, chi(2) test). Mutations at codons 10 and 36 of PR (present in 39.3% and 40.0% of patients in whom treatment failed, respectively) were identified by stepwise logistic regression as the strongest predictors of virologic failure (odds ratio, 2.20; 95% confidence interval, 1.30-3.75; P= .004). If confirmed in independent studies, this result may justify the increased use of HIV genotyping in drug-naive patients requiring antiretroviral therapy.

Switch to unboosted atazanavir (ATV 400 mg qd), although not licensed in Europe, is an attractive off-label option due to convenience and tolerability. However there is a substantial lack of data concerning efficacy of ATV 400 mg-based regimens outside the trial setting. Our aim was to perform a retrospective study of determinants of long term efficacy in 2 Italian large HIV clinics. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P48 Cite this article as: Bonora et al.: Analysis of determinants of long-term efficacy of unboosted atazanavir-based regimens in the clinical setting. Journal of the International AIDS Society 2010 13(Suppl 4):P48. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113051/