BMC Infectious Diseases最新文献

Background and aims: HBsAg seroclearance is a key indicator of functional cure in chronic HBV. We evaluated the efficacy of pegylated interferon-α (Peg-IFN-α) in HBeAg-negative patients and its association with T-cell subsets.

Methods: We retrospectively analyzed 618 patients, 34 of whom underwent longitudinal immune profiling.

Results: Among 618 patients, a total of 214 cases (34.6%) achieved HBsAg clearance, namely 214 cases in group R and 404 cases in group NR. The R group was younger, had longer treatment, and had lower baseline HBsAg levels compared to the NR group. In 34 HBeAg-negative patients with chronic HBV infection, we studied the distribution of CD4 + and CD8 + T cells at different stages of differentiation. After 24 weeks of interferon therapy, responders exhibited increased CD4 + TCM and stable CD8 + TCM levels, along with decreased CD8 + TEMRA and Th2 cells. In contrast, non-responders showed reductions in TCM, elevated TEMRA, and Th2 cells. Responders exhibited a marked decline in PD-1 + CD8 + and CD160 + CD8 + T cells (at 0.97 and 0.95 times the baseline), whereas non-responders showed relative increases (at 1.74 and 1.55 times the baseline).

Conclusion: Peg-IFN-α may promote HBsAg clearance in selected HBeAg-negative patients with low antigen burden and partially reversible T-cell exhaustion.

Background: Dried blood spot (DBS) samples can improve access to hepatitis C virus (HCV) testing among hard-to-reach and underserved populations. We conducted a multicentre diagnostic accuracy study to evaluate the clinical performance of the Abbott RealTime HCV assay on the m2000 platform for detecting HCV RNA, using a standardized DBS collection and elution protocol.

Methods: The study was conducted at four sites in Cameroon, Rwanda, Georgia and Greece. DBS prepared from capillary and venous blood samples were collected from three target populations; individuals at risk of HCV infection, persons living with HCV, and individuals previously treated for HCV. Plasma samples tested on the Abbott m2000 platform served as the reference standard.

Results: A total of 936 participants were enrolled, of whom 76.6% were HCV antibody positive. Both capillary and venous DBS demonstrated high diagnostic accuracy. Sensitivity and specificity were 95.2% (95% CI: 92.9-96.8) and 95.6% (95%CI: 93.3-97.1) for capillary DBS, and 95.4% (95% CI: 93.1-97.0) and 96.0% (95% CI: 93.8-97.4) for venous DBS. The Abbot RealTime HCV assay on the Abbott m2000 platform showed strong clinical performance for detecting HCV RNA from DBS.

Conclusion: These findings support the use of DBS as a feasible and less resource-intensive alternative to plasma-based testing, potentially expanding HCV screening and diagnosis in decentralized settings. Reliable DBS testing relies on proper sample collection, appropriate handling, and adequate staff training.

Clinicaltrials:

Gov identifier: NCT03896087 (registered on 14 March 2019) available here: Study Details | Evaluation of Dried Blood Spot for HCV RNA Testing | https://clinicaltrials.gov/.

Background: This study aimed to identify the factors influencing retention in care among individuals living with Human Immunodeficiency Virus (HIV), with the goal of emphasising improved treatment compliance and health outcomes.

Methods: This retrospective, single-centre study included 300 individuals living with HIV who had been followed for at least two years. Patients who adhered to their follow-ups at three-month intervals for two years after their initial appointment and subsequently attended follow-ups at least twice a year for at least six months thereafter were considered to have "retention in care". We evaluated the effects of several factors, including age, sex, time to the first visit after diagnosis, use of telehealth services, daily pill count, dose frequency, and the time interval between the first visit and the commencement of treatment, on follow-up outcomes.

Results: The study population (mean age of 36.8 ± 11.91 years) included 269 (89.7%) males. Overall, there were 258 cases (86%) in which the time between diagnosis confirmation and the first visit was less than one month. Moreover, 227 individuals (75.6%) retained in care. The utilisation of telehealth services had a significant effect on follow-up consistency (p < 0.001). Age, sex, time to the first visit after diagnosis, daily pill count, dose frequency, and the time interval to treatment initiation did not affect retention in care.

Conclusions: Telehealth services have shown a substantial correlation with retention in HIV care and should be integrated into care models for better patient outcomes.

Background: Drug-resistant tuberculosis (DR-TB) continues to pose a threat to public health worldwide. Rifampicin (RIF) resistance is mostly caused by mutations in the rpoB gene, which codes for the β -subunit of RNA polymerase and is also an important surrogate marker for multidrug-resistant tuberculosis (MDR).

Objective: This study aimed to detect the rpoB gene mutations associated with RIF resistance and identify the risk factors for MDR/ RIF resistance patterns in individuals infected with pulmonary TB.

Methods: A facility-based cross-sectional study was conducted at selected TB treatment center hospitals (Felegehiwot, Debre-tabor, University of Gondar, Debark, and Metema hospitals) from June to December 2023 in the Northwestern Amhara regional state of Ethiopia. A total of 206 pulmonary TB patient's sputum samples were included. The study participants' Socio-demographics and clinical and behavioral characteristics were collected through semi-structured questionnaires. Then all GeneXpert^® MTB/RI-positive sputum specimens of bacterial isolates were culturedin a conventional egg-based solid Lowenstein-Jensen (LJ) medium. MTB Genomic DNA was extracted using GenoLyze Kit. The allele-specific Amplification Refractory Mutation System Polymerase Chain Reaction (ARMS PCR) approach was employed on whole DNA samples from 206 Culture positive isolates using three distinct codon-specific primers (D516V, H526Y, and S531L).

Results: An isolate is classified as RR-TB if it carries any mutation in the rpoB gene. Most Single nucleotide polymorphism (SNP) mutations were observed on rpoB S531L 19 (9.2%). Of 206 confirmed clinical isolates, 21 (10.2%) were RIF Resistant, while the remaining 185 (89.8%) were RIF susceptible. Before TB treatment history (AOR = 4.27, CI 1.29-14.20, p = 0.02), and Window opening practice of patients (AOR = 6.17, CI 1.22-31.29, p = 0.03) were significantly associated with RR-TB development.

Conclusion: The prevalence of RR (RIF Resistant) -TB among TB-confirmed cases was 21 (10.2%). This implies that RR-TB is a serious health problem in the study population. The S531L was the most common mutation conferring resistance to RIF.

Clinical trial number: Not applicable.

Background: Affordable HPV vaccines are needed to accelerate elimination of cervical cancer. We evaluated the efficacy, safety, and immunogenicity of a recombinant bivalent human papillomavirus (HPV) vaccine composed of L1 virus-like particles (VLPs) for HPV 16 and HPV18 (HPV-2), produced in Pichia pastoris, in healthy Chinese women aged 18-30 years.

Methods: In this phase 3, double-blind, randomised, placebo-controlled trial conducted at 10 centres in China (Nov 2014-Jan 2020), participants were assigned 1:1 to receive three doses of HPV-2 or placebo at months 0, 2, and 6. The primary endpoint was efficacy against histopathology-confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with HPV16/18 through 48 months. Secondary endpoints were safety (adverse events [AEs] within 1 month of any dose; serious AEs throughout follow-up) and immunogenicity (neutralising antibody titres and seroconversion at Month 7 in a predefined subset).

Results: Of 12,000 women enrolled, 11,999 received the first dose and 11,281 completed all three doses. Over 48 months, 17 CIN2 + cases occurred: 3 among vaccine recipients (n = 5190) versus 14 among placebo recipients (n = 5167), corresponding to vaccine efficacy of 78.6% (95% CI 23.3-96.1; p = 0.012). No vaccine-related serious AEs occurred. Solicited local AEs were mainly mild pain, reported by 25.9% of vaccinees and 7.9% of placebo recipients. Fever was the most common systemic AE (27.4% vs. 26.4%). In the immunogenicity subset, 99.7% (349/350) and 99.4% (348/350) of vaccinees were seropositive for HPV16 and HPV18 neutralising antibodies, respectively, at Month 7.

Conclusions: Three doses of HPV-2 were well tolerated, highly immunogenic, and efficacious against CIN2 + up to 4 years post-vaccination, supporting further evaluation in the adolescent target population for HPV vaccination campaigns.

Trial registration: China Drug Trials Registry (CTR20140626; registered Sept 26, 2014; prospective).

Clinicaltrials: gov (NCT02733068; registered April 11, 2016; secondary).