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Due to shared risk factors for transmission, coinfection with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) is a very common event. The prevalence of HCV infection among HIV-positive patients averages about 35% in the United States and Europe, but in clinical populations where there is a great prevalence of intravenous drug use as a risk factor for acquiring HIV, this value may be as high as 80-90%. Several studies have confirmed that HIV coinfection accelerates the natural course of chronic hepatitis C and an increased risk of liver cirrhosis, hepatocellular carcinoma, and decompensated liver disease has been found in coinfected subjects. Other studies have shown an increased risk of progression to acquired immunodeficiency syndrome (AIDS) and AIDS-related death among HIV-HCV-positive persons, suggesting that HCV coinfection may accelerate the course of HIV disease. In addition, hepatitis C may affect the management of HIV infection, increasing the incidence of liver toxicity associated with the antiretroviral regimens. The optimal therapeutic approach to HCV infection in HIV coinfected patients is still uncertain, because of the complex pathogenesis of both infections, potential drugdrug interactions, and the poor literature and information available about safety and efficacy of an interferon (IFN) and ribavirin combination in this clinical population. Available data show that the sustained virological response rates in coinfected persons treated with standard IFN plus ribavirin range from 18-40%, and several studies with pegylated IFN plus ribavirin are ongoing.

IntroductionInsulin resistance in people living with HIV (PLWH) has become a growing concern. While modern antiretroviral therapy (ART) has reduced HIV-related morbidity and mortality, its effects on metabolic health remain critical.MethodsA retrospective cohort study was conducted with outpatients at our clinic who initiated long-acting cabotegravir/rilpivirine (LA CAB/RPV) between January 2023 and December 2024. The study aimed to evaluate changes in glucose homeostasis after 32 weeks of treatment. Participants were assessed at baseline (T0) and after 32 weeks on ART (T1). Clinical and metabolic parameters were compared to identify significant changes over time.ResultsForty-six participants were included, with a median age of 50 years (IQR 40.5–56.8), and 82.6% were male. At baseline, the cohort had a median BMI of 24.5 (IQR 22.2–26.1) and waist circumference of 90.2 cm (IQR 88.0–96.4). The prevalence of insulin resistance was 28.2%, while 36.9% had dyslipidemia. Baseline glucose was 84.9 mg/dL (IQR 77.0–91.3), median insulin was 8.8 µU/mL (IQR 5.1–11.3), and HOMA index was 1.9 (IQR 1.0–2.7). Previous treatments included mainly integrase inhibitors, with 3TC/DTG (28.2%) and TAF/FTC/BIC (15.2%) being most common.After 32 weeks on long-acting ART, body weight remained stable (75.5 kg at both T0 and T1), and BMI increased modestly from 24.5 to 24.7 (p>0.05). Waist circumference decreased slightly by 0.3 cm (p>0.05). Glycemia increased by 2.2 mg/dL (from 84.9 to 87.1 mg/dL), and insulin levels rose by 1.4 µU/mL (from 8.8 to 10.2 µU/mL), with a marginal increase in the HOMA index of 0.4 (p>0.05). The prevalence of insulin resistance remained unchanged at 28.2%.Lipid metabolism showed slight increases in total cholesterol (+9.3 mg/dL) and LDL (+7.5 mg/dL), while HDL decreased slightly by 0.5 mg/dL (p>0.05). Triglycerides decreased by 2.9 mg/dL (p>0.05). Additionally, 13.0% of participants experienced a weight gain >5%. Renal function showed no significant changes.Immune function remained stable, with CD4+ count decreasing slightly from 824.5 to 809 cells/mm³, and the CD4+/CD8+ ratio improved from 1.09 to 1.92. Viral suppression was robust, with 100% of participants maintaining HIV RNA <50 copies/mL.ConclusionIn our cohort, the switch to long-acting ART with cabotegravir and rilpivirine every 8 weeks led to a slight increase in insulin levels and HOMA-IR index, and these changes did not reach a statistical significance. Importantly, no significant alterations were found in body weight, glucose, or lipid parameters, and immunological and virological efficacy were preserved. These findings highlight the need for further research to explore the long-term effects of ART on glucose homeostasis and to determine optimal management strategies for potential metabolic changes.

BackgroundAntiretroviral therapy (ART) including tenofovir disoproxil fumarate (TDF) has been associated with an increased risk of bone loss in people with HIV (PWH) compared to tenofovir alafenamide (TAF). However there is no a direct comparison about changes in bone mineral density (BMD) between naive PWH starting bictegravir/emtricitabine/TAF (BIC/F/TAF) or doravirine/lamivudine/TDF (DOR/3TC/TDF).MethodsWe performed a retrospective, observational, cohort study on adult PWH in our Division of Infectious Diseases who started as initial antiretroviral therapy (ART) the single tablet regimen BIC/F/TAF or DOR/3TC/TDF between January 2020 and December 2022. The inclusion criteria were as follows: individuals naïve to ART; age >40 years; individuals who had a dual-energy X-ray absorptiometry (DXA) scan before ART initiation and had at least one follow-up DXA scan 12 months or more after ART initiation. BMD changes and variations in bone turnover markers [bone alkaline phosphatase (ALP) and beta-crosslaps (cLP)] were evaluated in participants who had follow-up DXA scans after >12 months of ART.ResultsAs a whole, 65 patients (59 males, mean age 48.5 years) were enrolled: 35 starting BIC/F/TAF and 30 DOR/3TC/TDF. Baseline characteristics were comparable between groups: median HIV RNA was 4.35 log10, median CD4 T lymphocyte count was 379 cells/mm3, and 6 patients (9.2%) had AIDS diagnosis. At baseline, 11 subjects (17%) were diagnosed with low BMD (T-score <-1.0 or Z-score <-2.0), without significant differences between groups. After a median follow-up of 14.4 months, decrease in median absolute BMD and changes in bone turnover markers were comparable between groups. The median reduction (IQR) in BMD at femur neck was -0.04 (-0.07, 0.00) g/cm2 in BIC/F/TAF group and -0.05 (-0.08, -0–01) g/cm2 in DOR/3TC/TDF group (p=0.198). The median change (IQR) in BMD at lumbar spine was -0.06 (-0.09, -0.01) g/cm2 in BIC/F/TAF group and -0.07 (-1.0, -0–02) g/cm2 in DOR/3TC/TDF group (p=0.276). The median changes (IQR) in bone turnover markers were: +7.2 (+4.9, +9.3) ng/mL in BIC/F/TAF group and +8.1 (+4.2, +10.7) ng/mL in DOR/3TC/TDF group for ALP (p=0.403), and +115 (+82, +153) ng/L in BIC/F/TAF group and +106 (+77, +141) ng/L in DOR/3TC/TDF group for cLP (p=0.552). After the median follow-up, virological efficacy was comparable: HIV RNA <50 copies/mL was obtained in 32 patients (91.4%) in BIC/F/TAF group and in 27 (90%) in the DOR/3TC/TDF group. The median increase in CD4 T lymphocyte count was comparable between groups (+156 and + 132 cells/mm3, respectively), such as incidence of adverse events (<10% in each group). However, weight gain was significantly greater in the BIC/F/TAF group (weight change: +1.86 Kg vs +0.81 Kg; p=0.008).ConclusionsIn our study, initial antiretroviral regimen with BIC/F/TAF or DOR/3TC/TDF caused comparable reduction in BMD and similar changes in bone turnover markers after a median follow-up of 14 months.

Despite potent antiretroviral activity, protease inhibitor-based pharmacological treatment of HIV disease has recently been associated with lipid and glucose metabolism abnormalities (more frequently hypertriglyceridemia and hypercholesterolemia). The aim of our open-label, randomized, prospective study was to evaluate the role of fibrates in the management of HIV-associated hyperlipidemia. Plasma lipid levels of 635 HIV-infected patients referred to our tertiary care center and who had been receiving protease inhibitor-based antiretroviral therapy for at least 12 months were evaluated. All patients presenting hypertriglyceridemia (> 300 mg/dl) of at least 6-month duration and unresponsive to a hypolipidemic diet and physical exercise were treated with bezafibrate (400 mg once daily), gemfibrozil (600 mg twice daily) or fenofibrate (200 mg once daily) for 12 months. 69 (10.9%) of the 635 observed patients received fibrate therapy: bezafibrate was employed in 25 cases, gemfibrozil in 22 and fenofibrate in 22. Hypolipidemic drugs led to a reduction of 41.2% and 23.3% vs baseline triglyceridemia and cholesterolemia, respectively, with a favorable tolerability profile. All used fibrates showed a similar, significant efficacy in the treatment of diet-resistant hyperlipidemia, but further studies seem necessary in order to establish the most appropriate guidelines for the management of dyslipidemia associated with highly active antiretroviral therapy (HAART).

Although the new injectable formulation cabotegravir -rilpivirine represents the latest innovative weapon for the treatment of HIV, further studies and data are needed to fully understand the effectiveness, the cost-benefit ratio and the possible negative aspectsThe list of patients was obtained by extrapolating from the administrative system the expenditure carried out in 2023 in the clinical pharmacy. Through the e4Cure portal, it was possible to follow reports in the period prior to the injection treatment and at each scheduled follow-upThe analysis included 38 patients with a mean age of 48 years. N.6 decided to voluntarily discontinue treatment due adverse events. The main side effect in all six patients was pain associated with the occurrence of myalgia at the injection site. After the first administration, the pain sensation was classified as mild in 14 patients, moderate in 12 and severe in 5. Interestingly, after the first injection, there were only 2 patients who reported no side effects, while with increasing number of administrations, the patients with no side effects was significantly higher. In particular, after the third administration, 11 has reported no adverse events while none reported a severe pain sensation. A similar picture emerged after the fourth administration, n.11 reported no adverse events as a result of the administration of the two drugs, and none reported the perception of severe or moderate pain. An economic analysis showed that the average price of oral therapies amounts to €991 for a two-month intake, while an extrapolation of the costs over 12 months results in average costs per patient of €5.948. The average total effective expenditure/patient for therapies up to Dec 2023, calculated on the basis of the average cost of oral therapy plus the introduction of the long-acting formulation at different times of the years is €6.764 with an increase in total expenditure of €29.778. However, a significant fact emerges when attempting to develop a projection of the expenditure delta for the year 2024 with the following patients treated with the long-acting formulation only, as an overall decrease in estimated expenditure of -€12.222 is observed when we compare the year 2023 with 2024, managing to almost fully amortize the cost of injection therapy only two years.Although pain at the injection site is a critical adverse effect in terms of the persistence of injection therapy, this phenomenon appears to be more pronounced during the first administrations, whereas it decreases during subsequent treatment phases. Although there is an initial increase in drug expenditure in the year when the long-acting regimen is introduced the investment seems to be almost fully amortized in the two years following the switch to therapy. Based on the observations, the long-term regimen thus appears to be an effective tool for curbing drug expenditure two and a half years after its introduction and improving adherence to HIV treatment.

BackgroundThe safety and efficacy of the single-tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral therapy-naive people living with HIV infection (PLWH) were established in two phase-3 randomized trials, showing minimal percent reductions in mean hip and spine bone mineral density (BMD) during a 5-year follow-up. However, data from real-life on BDM change in PLWH starting B/F/TAF are still lacking.MethodsWe performed a retrospective cohort study of PLWH aged >50 years, naive to antiretroviral therapy and who initated B/F/TAF in our HIV Clinic between 2020 and 2022. The percentage changes from baseline in hip and lumbar spine BMD were assessed at month 12. Virological efficacy, safety and changes in immunological and metabolic parameters after 12 months of treatment were also evaluated.ResultsInclusion criteria were met by 44 patients with median age of 56.2 years (range, 50–64): 37 (84%) men and 42 (95%) Caucasian. At baseline, mean HIV RNA was 4.68 log10, mean CD4 T lymphocyte count was 317 cells/mm3, and 19 (43%) patients had CD4 T lymphocyte count <350 cells/mm3. One or more comorbidities were present in 27 subjects (61%) and the most common comorbidities were hypertension and dyslipidemia. Osteopenia or osteoporosis was diagnosed in 11 subjects (25%). The mean percent change from baseline was -0.41% for spine and -1.22% for hip at month 12 (p=0.178 and p=0.096, respectively), and the number of patients with osteopenia or osteoporosis did not change during the follow-up. HIV RNA <50 copies/mL was obtained in 42 patients (95.4%) after 12 months and reasons for treatment failure were virological failure in one case (without resistance mutations at genotype testing) and adverse events (gastrointestinal symptoms) in one case. Overall, adverse events were reported in 12 cases (27%), were all of grade 1–2, and no serious events were described. The most common adverse events were diarrhea and gastrointestinal symptoms (in 13% of cases), headache (9%), and sleep disturbances (6%). At month 12, the median increase in CD4 T lymphocyte count was +161 cells/mm3. No significant changes in median value of lipids and creatinine were reported, and the median weight change was +2.1 Kg (no patients showed a >5% increase in body weight).ConclusionIn this real-life cohort of naive PLWH aged over 50 years, B/F/TAF as initial regimen produced a minimal and not significant decrease in hip and lumbar spine BMD during the first year, and was associated with high virological efficacy and good tolerability.

Stenotrophomonas (Xanthomonas) maltophilia has been increasingly reported as a nosocomial opportunistic pathogen, responsible for serious infectious complications in immunocompromised patients. At present very limited information is available concerning its clinical significance in the setting of HIV infection. A retrospective survey of clinical and microbiological records of 1,374 HIV-infected patients referring to our tertiary care center during a 10-year period (1991-2000) was performed to identify all episodes of S. maltophilia infection and analyze epidemiological, clinical and laboratory variables. The episodes of S. maltophilia bacteremia were compared with those caused by non-typhoid Salmonella spp. occurring in HIV-infected patients referring to our center during the same period, in order to evaluate eventual predisposing risk factors. 61 episodes of S. maltophilia infection were observed in 59 HIV-infected patients: sepsis/bacteremia in 48 cases (78.7%), lower airways infection in five, urinary tract infection in four, pharyngitis in two, lymphadenitis and liver abscess in one case each. 47 of 61 episodes (77%) of S. maltophilia infection occurred as nosocomial disease (i.e. were diagnosed after the 3rd day of hospitalization) and bacterial isolates showed an elevated resistance profile against many beta-lactam compounds, aztreonam, imipenem and aminoglycosides. At the same time, 38 episodes of bacteremia due to non-typhoid Salmonella spp. were diagnosed in our patients, 13 of which were nosocomial infections. When compared with non-typhoid Salmonella spp. bacteremia, a significantly higher risk of developing S. maltophilia disseminated infection was seen in association with advanced immunodeficiency, leukopenia-neutropenia, central venous catheterization, prior broad-spectrum antimicrobial therapy and/or corticosteroid treatment.

The use of the pre-established combination, emtricitabine/tenofovir disoproxil fumarate, for prophylaxis represents a new and effective tool for the prevention and containment of HIV infection.The list of analyzed patients was generated by using the GACC company management system, selecting as mode of operation the dispensing of medicines in the field of HIV pre-exposure prophylaxis. Through the E4Cure platform, it was possible to obtain information related to: Date of initiation of prophylaxis, schedule of intake, possible acquisition of HIV-1 infection and other major STDs such as HCV, HBV, syphilis, Chlamydia and gonococcus, as well as their serologic and possible vaccination status. Finally, information on HPV vaccination status was also recorded.Between Aug 2023 and Feb 2024, 517 patients had access to the medication dispensary of the Infectious Diseases Department to collect PrEP. The average age of the population was 38 years and 98% were men. We do not have data for 93 patients who were treated at the BLQ clinic. The analysis of 424 patients showed that the average duration of PrEP use was 17 months and that the preferred mode was ‘daily’ in 56.8% of cases .Of the 424 patients analyzed, 67 of whom had started treatment several months ago, so we have no data on the possible acquisition of the various STDs, as no further visits were conducted. Only 1 patient contracted HIV-1 during PrEP on demand, showing a 99.8% success rate of prophylaxis. However, in 357 patients, there are significant data on the acquisition of other sexually transmitted diseases. In particular, gonorrhoea is the most frequently recorded infection with at least one episode in 30.5% of patients; followed by Chlamydia trachomatis infections 26.8%, and Luetica 12.6%. 11 patients had at least one episode of each of the three STDs. No new HBV infections were diagnosed, while 1 case of HCV acquisition was diagnosed. Of the population analyzed, only 50.7% of cases were not infected with sexually transmitted pathogens. 77.6% of the total 424 patients analyzed were vaccinated against HBV, with 78.4% of cases having a protective antibody titer; in the remaining 8.2% serology was consistent with previous infection. Regarding protection against HPV, 42.9% of patients had been vaccinated with 3 doses, 27.1% had not been vaccinated and 7.3% was completing the vaccination cycle having received at least one administration, no data were available for 96 patients.It appears that pre-exposure antiretroviral chemoprophylaxis is indeed an effective means of preventing the acquisition of HIV-1 infection, as of all 357, patients only 1 patient acquired the infection during the study period, with a treatment success rate of 99.8%. However, 49.3% of patients were diagnosed with at least one STD. Therefore, although PrEP is an effective means of reducing the spread of HIV-1 infections, this treatment does not eliminate the possibility of contraction all other sexually transmitted diseases.

BackgroundLong-acting (LA) injectable cabotegravir (CAB) and rilpivirine (RPV) is a well-established and tolerated option for antiretroviral treatment (ART) in eligible people with HIV (PWH). This study aims to describe adverse events (AEs) reported in a multicentric, prospective cohort, assessing their severity and the timing of occurrence. Additionally, it explores the characteristics of PWH who experienced these reactions.Materials and MethodsThis observational, prospective multicentric study included PWH who started LA CAB/RPV regimen and developed an AE between July 2022 and February 2025. AEs were defined, according to the study protocol, as any harmful and unintended effect, graded using the DAIDS Adverse Event Grading, resulting from the use of the LA regimen. Data were described using mean ± standard deviation (SD) for normally distributed continuous variables, median and interquartile range (IQR) for not normally distributed continuous variables and percentage for categorical and ordinal variables.ResultsA total of 667 PWH who initiated the LA treatment were included, 512 were male (76.8%) and had a median age of 49 (IQR 40–58). Most were in CDC stage A (379/667, 56.8%) and had a mean prior ART duration of 12.0 years (SD 7.6). At baseline, 654/667 (98.0%) had undetectable viral load, with a median CD4+ T count of 780 cells/mm³ (IQR 568–1015). Additionally, 352/667 (52.8%) were on at least one concurrent treatment.In our cohort, 42 (6.3%) PWH developed ≥1 AE. In 7/42 (16.7%), AEs were difficult to correlate with the LA treatment or were not assessable.PWH with AEs had a median age of 54 years (IQR 47–61) and were mostly males (32/42, 76.2%); 26/42 (61.9%) were concurrently receiving at least one other pharmacological treatment. Most PWH staged CDC class A (21/42, 50.0%), with mean prior ART duration of 14.0 years (SD 9.1) and a baseline CD4+ T count of 750 cells/mm³ (IQR 497–1074). Baseline CD4+ T count was not significantly different between PWH with and without AEs (p=0.57).Prior to the initiation of LA regimen, 31/42 PWH (73.8%) received an oral ART with INSTIs, and 18/42 (42.9%) with NNRTIs. The median follow-up period for PWH with AE was 3 months (IQR 2–6); AEs mainly occurred within the first 66 days (IQR 28–176) after the first injection. Thirty-seven/42 (88%) PWH discontinued due to AEs. The most prevalent AEs were injection site reaction (13/42, 30.9%) and lower limb pain (7/42, 16.7%), followed by fever (6/42, 14.3%) and neurological symptoms (4, 9.5%). Nine PWH (21.4%) developed more than one AE.In regard to severity, only two AEs related to the LA regimen (34/42) were grade 4 and ten grade 3; 5/42 had no grading, while 18/34 were graded 1 and 2.Abstract SC28 Figure 1Development of adverse events over the course of treatment, with time zero defined as the start of treatment. Abbreviation: PWH - People with HIV[Figure omitted. See PDF]ConclusionsReal-life data confirm that LA CAB/RPV is well-tolerated, with most AEs occurring within the first months of treatment (figure 1). AE rates were lower than in registration trials, especially for injection site reaction, though more PWH discontinued LA due to AEs.

Primary cytomegalovirus disease is probably still underestimated or missed in common clinical practice, and further prevalence studies should be performed, in particular in the setting of fever of under-determined origin (FUO) in adults. In a 3-year prospective survey of 123 consecutive adult patients referred for FUO often associated with a broad spectrum of constitutional signs and symptoms, 18 patients (14.6%) were found to have a primary cytomegalovirus infection, after a clinical, instrumental and laboratory workup. In the majority of cases, this syndrome was consistently associated with altered white blood cell count, abnormal T-lymphocyte subsets and ultrasonography-confirmed hepatosplenomegaly. On the other hand, altered white blood cell differential and serum hepatic enzymes, and constitutional signs and symptoms were absent in 11.1-27.8% of cases, and an initial laboratory cross-reaction with anti-Epstein-Barr IgM antibodies was detected in 44.4% of episodes. Non-specific signs and symptoms were the only features in 27.8% of patients with adult cytomegalovirus disease, thus, confirming that this disorder may be still clinically underestimated, until virologic assays are performed. A prolonged and varied spectrum of subjective disturbances (similar to those encountered in infectious mononucleosis), which often limited daily activities, involved nearly 30% of subjects, and lasted for 3-15 months after recovery of acute cytomegalovirus disease. In the clinical, laboratory, and instrumental workup for FUO, rapid recognition of a primary cytomegalovirus disease is useful to exclude alternative diagnoses, avoid non-necessary exposure to antibiotics, and reassure patients of their self-limiting, benign disorder.