Twelve-month effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: Real-world insights from BICSTaR cohorts.

BACKGROUND: Real-world evidence is an essential component of evidence-based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in antiretroviral treatment-naïve (TN) and treatment-experienced (TE) people with HIV. METHODS: BICSTaR is a prospective, observational cohort study. Participants (≥18 years) are being followed for 24 months. A pooled analysis is presented at 12 months, with the primary endpoint of effectiveness (HIV-1 RNA <50 copies/mL) and secondary endpoints of safety and tolerability (as per protocol). An exploration of patient-reported outcome measures using standardized questionnaires is included. RESULTS: Between June 2018 and May 2021, 1552 people with HIV were enrolled across 12 countries. The analysed population comprised 1509 individuals (279 TN, 1230 TE); most were white (76%), male (84%) and had one or more comorbid conditions (68%). Median age was 47 years. After 12 months of B/F/TAF treatment, HIV-1 RNA was <50 copies/mL in 94% (221/236) of TN participants and 97% (977/1008) of TE participants. Median CD4 cell count increased by 214 cells/µL (p < 0.001) in TN participants and 13 cells/µL (p = 0.014) in TE participants; median CD4/CD8 ratios increased by 0.30 and 0.03, respectively (both p < 0.001). Persistence was high at 12 months (TN, 97%; TE, 95%). No resistance to B/F/TAF emerged. Study drug-related adverse events occurred in 13% of participants through 12 months, leading to B/F/TAF discontinuation in 6%. CONCLUSIONS: The findings of this study provide robust real-world evidence to support the broad use of B/F/TAF in both TN and TE people with HIV.

Factors Influencing HIV Infection in Children Born to HIV-Infected Mothers in Turkey

Background: Human immunodeficiency virus (HIV) is still a challenge for children. About 15 to 45% of the HIV positive pregnant women can transmit the virus to their children during pregnancy, delivery and/or breastfeeding. The risk of transmission can be decreased my several measures. Aims: To identify factors associated with HIV infection in children born to HIV-infected mothers. Study Design: A multi-center retrospective cohort study. Methods: A ten-year retrospective cohort study in five dedicated HIV centers was conducted. The 325 women in our cohort were between the ages of 18 and 45. During the study period, 44 (13.5%) of these women gave birth and 51 babies were born. Of the 51 infants, 7 (13.7%) were HIV/AIDS positive. Results: Among the factors studied, breastfeeding, having a HIV-positive sibling and being on antiretroviral treatment during pregnancy and detectable HIV-RNA during delivery were found statistically significant. A multivariable logistic regression analysis showed that being on antiretroviral treatment during pregnancy is the most important predictor of mother-to-child transmission. Conclusion: Mother-to-child transmission appears to be an important route of HIV transmission in Turkey. Lack of antiretroviral treatment during pregnancy appears to be a key factor in transmission.

Right atrial reservoir strain and right ventricular strain improves in patients recovered from hospitalisation for non-severe COVID-19.

PURPOSE: Those hospitalised with coronavirus disease 2019 (COVID-19) have recently been shown to have impaired right ventricular (RV) strain, but data about the course of heart function after discharge are limited. Our aim was to compare right ventricular strain and right atrial reservoir strain (RASr) associated with COVID-19 between acute disease (during hospitalisation) and follow-up (after discharge). METHODS: In this retrospective single-center study, we analysed the echocardiograms of 43 patients hospitalised for non-severe COVID-19 between December 2020 and March 2021, undergoing echocardiography both during and after hospitalisation. In addition to conventional echocardiographic parameters, we applied 2-dimensional speckle tracking to obtain RV global longitudinal strain (RV-GLS), RV free wall strain (RV-FWS), and RASr. RESULTS: Mean (standard deviation) age of the study population was 50 (9) years, and 18 (42%) of the participants were women. Median duration between exams was 6 months (range, 5-7 months). Both mean RV-GLS and mean RV-FWS significantly increased at follow-up (-20.8 [3.8] vs. -23.5 [2.8], p < 0.001 and -23.3 [4.2] vs. -28.2 [2.8], p < 0.001; respectively), and RASr significantly improved as well (-32.3 [6.6] vs. -41.9 [9.8], p < 0.001). CONCLUSION: In patients hospitalised for non-severe COVID-19 pneumonia, RV-GLS, RV-FWS, and RASr improved significantly between acute disease and 6 months after discharge.

Comparison of the Clinical and Laboratory Findings and Outcomes of Hospitalized COVID-19 Patients Who Were Either Fully Vaccinated with Coronavac or Not: An Analytical, Cross Sectional Study.

COVID-19 vaccines are highly protective against severe disease; however, vaccine breakthrough infections resulting in hospitalization may still occur in a small percentage of vaccinated individuals. We investigated whether the clinical and microbiological features and outcomes were different between hospitalized COVID-19 patients who were either fully vaccinated with Coronovac or not. All hospitalized COVID-19 patients who had at least one dose of Coronavac were included in the study. The oldest unvaccinated patients with comorbidities, who were hospitalized during the same period, were chosen as controls. All epidemiologic, clinical and laboratory data of the patients were recorded and compared between the fully vaccinated and unvaccinated individuals. There were 69 and 217 patients who had been either fully vaccinated with Coronavac or not, respectively. All breakthrough infections occurred in the first 3 months of vaccination. Fully vaccinated patients were older and had more comorbidities than unvaccinated patients. There were minor differences between the groups in symptoms, physical and laboratory findings, anti-spike IgG positivity rate and level, the severity of COVID-19, complications, and clinical improvement rate. The mortality rate of fully vaccinated patients was higher than the mortality rate in unvaccinated patients in univariate analysis, which was attributed to the fact that vaccinated patients were older and had more comorbidities. The severity and clinical outcomes of hospitalized patients with breakthrough COVID-19 after Coronavac vaccination were similar to those of unvaccinated patients. Our findings suggest that the immune response elicited by Coronovac could be insufficient to prevent COVID-19-related severe disease and death within 3 months of vaccination among elderly people with comorbidities.

Increasing modified CHA2DS2-VASc risk score is associated with acute cardiac injury in hospitalised COVID-19 patients.

BACKGROUND: Prediction of hospital mortality in patients with COVID-19 by the CHA2DS2VASc (M-CHA2DS2VASc) has been recently shown. Because COVID-19 patients with acute cardiac injury have higher mortality compared to those without, we assumed that this risk score may also predict acute cardiac injury in these patients. METHODS: In this retrospective, single centre cohort study, we included 352 hospitalised patients with laboratory-confirmed COVID-19 and divided into three groups according to M-CHA2DS2VASc risk score which was created by changing gender criteria of the CHA2DS2VASc from female to male (Group 1, score 0-1 (n = 142); group 2, score 2-3 (n = 138) and group 3, score ≥4 (n = 72)). RESULTS: As the M-CHA2DS2VASc risk score increased, acute cardiac injury was also significantly increased (Group 1, 11.3%; group 2, 48.6%; group 3, 76%; p < 0.001). The higher M-CHA2DS2VASc tertile had higher prevalence of arrhythmias compared to lower tertile. The multivariate logistic regression analysis showed that M-CHA2DS2VASc risk score, admission to intensive care unit and invasive mechanical ventilation were independent predictors of acute cardiac injury (p = 0.001, odds ratio 1.675 per scale for M-CHA2DS2VASc). In receiver operating characteristic analysis, M-CHA2DS2VASc risk score was able to predict acute cardiac injury (Area under the curve value for acute cardiac injury was 0.80; p < 0.001). CONCLUSION: Admission M-CHA2DS2VASc risk score was associated with acute cardiac injury in hospitalised patients with COVID-19.

Foodborne streptococcal tonsillopharyngitis outbreak in a hospital.

OBJECTIVE: Group A beta-haemolytic streptococci (GAS), which are responsible for most cases of acute bacterial tonsillopharyngitis, are transmitted from person to person and may rarely cause foodborne outbreaks. This study aims to report the epidemic caused by GAS in our hospital and to draw attention to the explosive outbreaks of the bacteria. METHODS: Acute tonsillopharyngitis was seen in 201 of 450 hospital employees who ate in the hospital cafeteria on 4-5 June 2015. RESULTS: GAS was detected in 106 (68%) of 157 cases and in 40 (63.5%) of 62 throat culture samples. The attack rate was 44.7%. The most suspected source of the outbreak was a food handler who had been showing signs of streptococcal tonsillopharyngitis for six days, and perhaps the food prepared by these staff. CONCLUSION: It should not be forgotten that GAS can cause explosive outbreaks by infecting food through hand lesions or mouth secretions of food service personnel.

Toxoplasma gondii IgG Seroprevalence in Patients with HIV/AIDS.

OBJECTIVE: Toxoplasmosis is a common opportunistic infection in patients with HIV/AIDS and may cause life-threatening clinical courses, such as encephalitis and pneumonia. METHODS: Patients admitted between January 2006 and August 2017 with anti-HIV positivity confirmed by Western blotting were included in the study. Demographic data, CD4+ T-lymphocyte counts, and Toxoplasma gondii IgG/IgM levels were retrospectively obtained from patient records. RESULTS: T. gondii IgM positivity was not detected in patients, whereas T. gondii IgG positivity was detected in 267 (43.5%) patients. The T. gondii IgG positivity rate was 37.6% in men who had sex with men (MSM) and 48.4% in heterosexual patients. Furthermore, 42.6% of MSM and 21% of heterosexual patients were university graduates, of which T. gondii IgG positivity was detected in only 33.6% of MSM patients and 42.3% of heterosexual patients. CONCLUSION: In our study, high seronegativity was remarkable in MSM patients, particularly those who were highly educated, thus emphasizing the importance of prevention of primary infection in seronegative patients; necessity of prophylaxis in appropriate patients due to encephalitis, which has a high mortality rate and almost always develops after a latent infection; and necessity of screening for toxoplasmosis seropositivity at the time of diagnosis.

Human immunodeficiency virus and tuberculosis coinfection: clinical features and predictors of mortality

Background/aim: This study was undertaken to identify subjects with human immunodeficiency virus and tuberculosis (HIV/TB) coinfection in a group of HIV-positive patients followed at five different healthcare centers, and to determine the demographic and clinical characteristics of these subjects as well as the predictors of mortality. Materials and methods: A database search for subjects with TB coinfection was performed among 1475 HIV-positive adult patients and a total of 66 individuals were identified with HIV/TB coinfection. Results: There were 66 patients (4.5%) with TB coinfection. Twenty-one percent (n = 14) of the patients with TB coinfection died during the study period and these patients had significantly lower baseline CD4 counts at the time of TB diagnosis (P = 0.005). None of the patients with CD4 count of ≥200 cells/mm3 died during follow-up and a low CD4 count at the time of TB diagnosis (<200 cells/ mm3) was associated with poor survival (P = 0.012). However, none of the parameters emerged as significant independent predictors of survival in multivariate analysis. Conclusion: Coexistence of TB and HIV infection is associated with many clinical challenges and a better understanding of patient characteristics as well as the parameters impacting the outcome will improve the quality of care provided for this group of patients.

Primary Conjunctival Tuberculosis.

A 12-year-old girl was referred to our clinic because of unilateral conjunctivitis not responding to treatment. In the left eye, lower bulbar and tarsal conjunctiva had a polypoidal appearance due to micronodules and there was a subconjunctival nodular mass in the inferior fornix. Systemic examination was unremarkable except for a left preauricular lymphadenopathy. Excision biopsy of the subconjunctival mass revealed a granulomatous inflammation with caseation necrosis, but acid-fast bacilli (AFB) was negative. Fine needle-aspiration biopsy of the preauricular lymph node was performed. In microbiological examination, both AFB and mycobacterial culture were positive. The isolated mycobacteria strains were identified as Mycobacterium tuberculosis complex and full remission was achieved with 6 months of anti-tuberculosis treatment. Although primary tuberculous conjunctivitis is a very rare condition, it should be considered in the differential diagnosis of treatment-resistant unilateral conjunctivitis. For definitive diagnosis, microbiological and histopathological examinations should be performed both in conjunctiva and regional lymph node.

Adherence to Antiretroviral Therapy in Turkey: Results from the ACTHIV-IST Study Group.

Maintaining optimal adherence to antiretroviral therapy (ART) is essential for optimizing the management of HIV infection. The aim of this study is to explore ART adherence rates in Turkey. Included in this study were a total of 263 HIV-infected patients followed up by the ACTHIV-IST (ACTion against HIV in Istanbul) Study Group affiliated with four tertiary hospitals. The study population included patients 18 years of age or older who were on ART for over 12 months. Adherence was assessed by the medication possession ratio (MPR) calculated for each patient using data (a list of all drugs dispensed within the previous year for that patient) obtained from pharmacy medication records. In addition, patients completed a self-report questionnaire addressing missed doses and the AIDS Clinical Trials Group (ACTG) adherence questionnaire. The study was reviewed and approved by the Ethics Committee of Cerrahpasa Medical Faculty. Patient ages ranged from 19 to 71 years. Two hundred and thirty-one patients were male (88%). Two hundred and twenty-four patients (85%) had optimal adherence (MPR ≥95%). During the course of ART, 236 patients (90%) reported no missed doses in the past 4 days of their treatment, whereas 206 patients (78%) reported no missed doses in the past month. Simply forgetting was the most common reason for nonadherence. MPR was associated with virologic rebound. Major factors affecting adherence were being female, taking antituberculosis drugs, having an opportunistic infection, being able to take all or most of the medication as directed, and being aware of the need to take medication exactly as instructed to prevent the development of drug resistance. Adherence to ART measured by MPR and self-report surveys is relatively high in Turkey when compared with other countries, which probably led to high ART success rates.

Mucocutaneous manifestations and the relationship to CD4 lymphocyte counts among Turkish HIV/AIDS patients in Istanbul, Turkey.

BACKGROUND/AIM: Dermatologic findings differ among countries but no sufficient data about Turkish HIV-infected patients exist in the literature. Therefore, our aim in this study was to document the dermatologic manifestations and their relationships with CD4 cell counts among HIV/AIDS patients visiting our clinic for the first time in Istanbul, Turkey. MATERIALS AND METHODS: A retrospective analysis of 306 HIV/AIDS patients (260 men, mean age: 38.3 years) was done in a tertiary hospital in Istanbul from January 2006 to September 2012. Information on age, sex, transmission routes, socioeconomic and educational status, CD4 counts, and dermatologic findings was collected retrospectively from medical records. RESULTS: Our analyses revealed at least 1 dermatologic disease in 111 of the 306 (36.2%) patients. Mean CD4 count of the patients was 393.64 cells/mm3 (range: 4-1270 cells/mm3). Oral candidiasis (12.4%), herpes zoster (5.9%), dermatophytosis (5.4%), hyperpigmentation (5.2%), and folliculitis (4.6%) were the most common skin problems. Statistically significant correlation (P < 0.05) with low CD4 cell counts was found for oral candidiasis, folliculitis, herpes zoster, hyperpigmentation, xerosis, and Kaposi's sarcoma. CONCLUSION: Dermatologic manifestations in this study were identical to those described in most studies from Asia, and there were more manifestations as the HIV infection progressed and immune functions declined.