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.

Scrutinizing Clinical Biomarkers in a Large Cohort of Patients with Lyme Disease and Other Tick-Borne Infections.

Standard clinical markers can improve tick-borne infection (TBI) diagnoses. We investigated immune and other clinical biomarkers in 110 patients clinically diagnosed with TBIs before (T0) and after antibiotic treatment (T2). At T0, both the initial observation group and patients without seroconversion for tick-borne pathogens exhibited notably low percentages and counts of CD3 percentage (CD3%), CD3+ cells, CD8+ suppressors, CD4 percentage (CD4%), and CD4+ helper cells, with the latter group showing reductions in CD3%, CD3+, and CD8+ counts in approximately 15-22% of cases. Following treatment at the T2 follow-up, patients typically experienced enhancements in their previously low CD3%, CD3+ counts, CD4%, and CD4+ counts; however, there was no notable progress in their low CD8+ counts, and a higher number of patients presented with insufficient transferrin levels. Moreover, among those with negative serology for tick-borne infections, there was an improvement in low CD3% and CD3+ counts, which was more pronounced in patients with deficient transferrin amounts. Among those with CD57+ (n = 37) and CD19+ (n = 101) lymphocyte analysis, 59.46% of patients had a low CD57+ count, 14.85% had a low CD19 count, and 36.63% had a low CD19 percentage (CD19%). Similar findings were observed concerning low CD57+, CD19+, and CD19% markers for negative TBI serology patients. Overall, this study demonstrates that routine standard clinical markers could assist in a TBI diagnosis.

Enhancing long COVID care in general practice: A qualitative study.

INTRODUCTION: Research suggests that general practice can play an important role in managing long COVID. However, studies investigating the perspectives of general practitioners (GPs) and patients are lacking and knowledge regarding optimal long COVID care in general practice is therefore limited. AIM: To investigate GPs' and patients' perspectives on the topic of long COVID and its management in general practice. METHODS: Brief questionnaires (GP n = 11, Patient n = 7) and in-depth semi-structured interviews (GP n = 10, Patient n = 7) were conducted with GPs and patients from Irish general practices during July 2022-January 2023. Interviews were conducted via telephone and audio recordings were transcribed. A phenomenological analysis involving reflexive thematic analysis and constant comparison techniques was adopted. RESULTS: Analysis of interviews with GPs (male = 7, female = 3; median age = 50yrs (IQR = 39.5-56)) and patients (males = 2, female = 5; median age = 58yrs (IQR = 45-62yrs) generated four themes. These were (1) Complex presentations (2) the value of standardising care, (3) choosing the right path, and (4) supportive and collaborative doctor-patient relationships. Strong agreement was observed among GPs and patients regarding the need for holistic and integrated multidisciplinary care. Supportive and collaborative doctor-patient relationships were largely well received by GPs and patients also. GPs strongly endorsed standardising long COVID care operations. CONCLUSION: GPs and patients indicated that structured, integrated, and collaborative care can help optimise long COVID management in general practice. GPs are advised to incorporate these elements into their long COVID care practices going forward. Future research examining stakeholder's perspectives using larger and longitudinal samples is advised to enhance the generalisability of evidence in this area.

Hepatitis C community prevalence is over-estimated: a prospective, birth cohort study.

BACKGROUND: Hepatitis C virus infection is often asymptomatic, and many patients may be unaware they are infected. Community-based, birth cohort screening has been advocated to identify these patients. It has been estimated that 0.7-1% of individuals born between 1965 and 1985 in Ireland are infected. The cost-effectiveness of screening is critically dependent on the population prevalence. AIMS: The aim is to determine the community prevalence of hepatitis C virus infection in the birth cohort 1965-1985. METHODS: Residual serum samples from blood tests ordered by community general practitioners were anonymised and analysed for the presence of hepatitis C antibody ± antigen. Twelve large general hospitals throughout the country participated. RESULTS: A total of 14,320 samples were tested, 9347 of which were from the birth cohort 1965-1985. Seventy-two samples were positive for hepatitis C antibody of which 12 were positive for hepatitis C antigen (17%). The overall prevalence of hepatitis C antigen in the birth cohort was 0.09%. A higher prevalence (0.39%) was identified in males in two urban areas of Dublin. CONCLUSIONS: Hepatitis C virus seroprevalence was much lower than previously estimated. The proportion of antibody positive patients with hepatitis C antigen was also lower than expected suggesting the effects of treatment and/or high spontaneous viral clearance. Universal birth cohort screening is unlikely to be cost-effective. Targeted birth cohort screening in high prevalence areas could be considered.

Toxoplasmic encephalitis in an HIV infected pregnant woman: successful outcome for both mother and child

This report describes a case of Toxoplasma encephalitis during pregnancy of an HIV infected woman who was severely immunosuppressed (CD(4): 17 cells/mm3), had a high viral load (RNA PCR:230,000 copies/ml), was treated with sulfadiazine, pyrimethamine and folinic acid for toxoplasmosis and was being treated with highly potent antiretroviral drugs (AZT, 3TC and nelfinavir) for HIV infection. The newborn was born through an elective C-section, received six weeks of AZT according to the 076 protocol and was clinically normal at birth. Subsequently he had two RNA PCR negatives for HIV, seroreverted and had no clinical or laboratory evidence of congenital toxoplasmosis. Despite the concerns of the use of these combined therapies on the foetus during pregnancy, their efficacy illustrates that keeping the mother alive and in good health is an important strategy to protect the unborn child from acquiring these two infections.

Bacillary angiomatosis: description of 13 cases reported in five reference centers for AIDS treatment in Rio de Janeiro, Brazil

The aim of this case series was to describe the clinical, laboratory and epidemiological characteristics and the presentation of bacillary angiomatosis cases (and/or parenchymal bacillary peliosis) that were identified in five public hospitals of Rio de Janeiro state between 1990 and 1997; these cases were compared with those previously described in the medical literature. Thirteen case-patients were enrolled in the study; the median age was 39 years and all patients were male. All patients were human immunodeficiency virus type 1 (HIV-1) infected and they had previous or concomitant HIV-associated opportunistic infections or malignancies diagnosed at the time bacillary angiomatosis was diagnosed. Median T4 helper lymphocyte counts of patients was 96 cells per mmÝ. Cutaneous involvement was the most common clinical manifestation of bacillary angiomatosis in this study. Clinical remission following appropriate treatment was more common in our case series than that reported in the medical literature, while the incidence of relapse was similar. The frequency of bacillary angiomatosis in HIV patients calculated from two of the hospitals included in our study was 1.42 cases per 1000 patients, similar to the frequencies reported in the medical literature. Bacillary angiomatosis is an unusual opportunistic pathogen in our setting

Overview of genotypic and clinical profiles of human immunodeficiency virus type 1-infected children in Rio de Janeiro, Brazil

Embora os protocolos de prevenção da transmissão materno-infantil do HIV tenham diminuído a infecção pediátrica pelo HIV nos países desenvolvidos, um grande número de crianças ainda se infectam nas nações em desenvolvimento. Dados disponíveis de infecção pediátrica são entretanto ainda escassos. Neste trabalho, nós conduzimos um levantamento clínico, laboratorial e genotípico de um grande coorte de crianças infectadas pelo HIV em acompanhamento em dois grandes centros de atendimento de HIV/AIDS pediátrica do Rio de Janeiro. Crianças em tratamento anti-retroviral, bem como crianças recentemente diagnosticadas e ainda virgens de tratamento foram analisadas. A prevalência de mutações de resistência às drogas, beem como as respostas imunológicas e virológicas ao tratamento foram avaliadas. Além disso, as frequências dos subtipos do HIV-1 e a sua distrbuição ao longo da epidemia de HIV/AIDS no Brasil foram estudadas. Nós observamos uma alta prevalência de mutações de resistência em vírus de crianças em tratamento, ao passo que o grupo virgem de tratamento não possuía mutações. Apesar dos altos níveis de mutações nas crianças tratadas, uma significativa melhora de sua condição imunológica foi observada. A distribuição de subtipos do HIV-1 seguiu as tendências da população adulta, com o aparecimento de subtipos não-B e de formas recombinantes após 1990. Dentro do nosso conhecimento, este é o maior coorte pediátrico de HIV/AIDS já analisado no Brasil, e os resultados obtidos são de suma importância para um melhor entendimento da evolução do HIV/AIDS em um contexto pediátrico.

Successful prevention of HIV transmission from mother to infant in Brazil using a multidisciplinary team approach

Objectives: To determine the HIV vertical transmission rate (VTR) and associated risk factors by use of zidovudine and infant care education in Brazil. Methods: Since 1995, a prospective cohort of HIV infected pregnant womwn has been followed at the Federal University of Rio de Janeiro. A multidisciplinary team was established to implement the best available strategy to prevent maternal-infant HIV transmission. Patients with AIDS or low CD4 and high viral load received anti-retroviral drugs in addition to zidovudine. Children were considered infected if they had 2 positive PCR-RNA test between 1 and 4 months of age, or were HIV antibody positive after 18 months. Education regarding infant treatment and use of formula insteadof breast feeding was provided. Results: Between 199 and August, 2000. HIV status was determined for 145 infants. Compliance with intra-partum treatment, infant treatment and use of formula was 88.2 percent. Intra-partum zidovudine treatment was completed in 134/145 (92.6 percent) of patients; 88.1 percent had rupture of membranes < 4 hours; 85.4 percent of mothers were asymptomatic. The mean CD4 count was 428,4 cells and mean viral load 39,050 copies. HIV vertical transmission rate was 4/145 (2.75 percent; CI: 0.1 percent - 5.4 percent). The only risk factor significantly associated with transmission was a failure to use zidovudine intra-partum in 2 of the 4 mothers (50 percent versus 6.4 percent in non-transmitting mothers). A trend toward low CD4 and high viral load at entry, and rupture of membranes > 4 hours were associated with increased HIV transmission. Conclusion: HIV vertical transmission in Brazil was reduced to a level similar to other countries with the most effective prevention programs using a multidisciplinary team approach. A high levelof compliance for use of anti-retroviral drugs, the provision of health education to mothers, and use of formula for all exposed infants.

Manual para acompanhamento clínico da gestante infectada pelo HIV / Handbook for attendance clinical of the pregnant infected for the HIV

Trata especificamente dos problemas obstétricos de mulheres infectadas pelo HIV. Reflete a urgência de enfrentar a atual realidade mundial da epidemiologia e clínica da infecçäo pelo HIV