Objective:To analyze the efficacy and safety of integrase inhibitor-based single-tablet regimens bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and lamivudine/dolutegravir (3TC/DTG) in the treatment-na?ve patients with acquired immunodeficiency syndrome (AIDS).Methods:This study was a retrospective cohort study. The clinical data of treatment-na?ve AIDS patients initiating anti-retroviral therapy (ART) with B/F/TAF or 3TC/DTG and on ART for greater than or equal to 24 weeks from October 2020 to July 2023 in Shanghai Public Health Clinical Center, Fudan University were collected. The baseline human immunodeficiency virus (HIV)-1 RNA, CD4 + T lymphocyte counts at baseline and 12 weeks of treatment, and the rates of virological suppression and virological failure at 24 weeks of treatment, and levels of total cholesterol, serum creatinine, uric acid before and after treatment were compared between the B/F/TAF group and 3TC/DTG group. Independent sample t test, corrected t test, Mann-Whitney U test, Wilcoxon signed rank test, chi-square test were used for statistical analysis. Results:Among 189 treatment-na?ve AIDS patients, 141 cases were in B/F/TAF group and 48 cases in 3TC/DTG group. The HIV-1 RNA level at baseline was 1.77(0.78, 4.52)×10 5 copies/mL in the B/F/TAF group and 0.97(0.24, 2.20)×10 5 copies/mL in the 3TC/DTG group. There was a statistically significant difference between the two groups ( U=2 221.00, P=0.006).There were 77.3%(109/141) patients on B/F/TAF achieved complete virological suppression with no virological failure at week 24, and 85.4%(41/48) on 3TC/DTG achieved complete virological suppression with one (2.1%) virological failure at week 24. At 12 weeks of treatment, 92.2%(130/141) of the patients in the B/F/TAF group and 85.4%(41/48) of the patients in the 3TC/DTG group had an increase in CD4 + T lymphocyte count by more than 30% compared with baseline. The proportion of CD4 + T lymphocyte count increased by more than 100/μL from baseline in the B/F/TAF group was 67.4%(95/141), and that in the 3TC/DTG group was 52.1%(25/48). There were no significant differences between the two groups ( χ2=1.91 and 3.61, respectively, P=0.167 and 0.733).The levels of total cholesterol ( W=2 036.00, t=-5.42, respectively), serum creatinine ( W=1 098.00, 234.00, respectively), uric acid ( W=2 188.00, 299.00, respectively) and the proportion of patients with mild to moderate renal insufficiency ( χ2=22.29, 8.22, respectively) in the B/F/TAF group and 3TC/DTG group after 24 weeks of treatment were significantly higher than those before treatment (all P<0.01). Conclusions:Both B/F/TAF and 3TC/DTG are effective in terms of virological suppression and immunological recovery and have good safety profiles in treatment-na?ve patients with AIDS.

Objective:To analyze the changes of pathogen spectrum of pulmonary infection in human immunodeficiency virus (HIV) infection/acquired immunodeficiency syndrome (AIDS) patients before and during coronavirus disease 2019 (COVID-19) epidemic.Methods:The clinical data of hospitalized HIV infection/AIDS patients with pulmonary infection confirmed by etiology and/or imaging examinations in the Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University from January 2017 to December 2022 were collected, including the types of pathogens, the peripheral blood CD4 + T lymphocyte counts at admission due to pulmonary infection, and the treatment outcome of the patients at discharge. The changes of pathogen spectrum of pulmonary infection before COVID-19 epidemic (2017 to 2019) and during the epidemic (2020 to 2022) were analyzed, and their effects on adverse treatment outcomes (death during hospitalization or automatic discharge) were analyzed. Statistical analysis was performed using the chi-square test, trend chi-square test or Kruskal-Wallis test. Results:The proportion of patients with pulmonary infection during the epidemic was lower than that before the epidemic, the difference was statistically significant (23.01%(1 061/4 612) vs 28.68%(1 463/5 102), χ2=40.76, P<0.001). From 2017 to 2022, the proportion of hospitalized HIV infection/AIDS patients with pulmonary infection showed a downward trend ( χ2trend=8.81, P<0.001). Among the pathogens causing pulmonary infection from 2017 to 2022, bacteria, mycobacteria, and fungi were the three main pathogenic pathogens, accounting for 48.77%(1 231/2 524), 32.13%(811/2 524), and 14.34%(362/2 524), respectively. The proportion of bacterial infection decreased from 55.02%(805/1 463) before the epidemic to 40.15%(426/1 061) during the epidemic, and the proportion of fungal infection increased from 9.23%(135/1 463) to 21.39%(227/1 061), the differences were both statistically significant ( χ2=54.45 and 74.11, respectively, both P<0.001). There was no significant difference in the proportion of mycobacteria between before and during the epidemic ( P=0.169), but the proportion of Mycobacterium tuberculosis (MTB) infection decreased from 22.01%(322/1 463) before the epidemic to 15.08%(160/1 061) during the epidemic, while the proportion of nontuberculous mycobacterium (NTM) infection increased from 7.11%(104/463) to 11.78%(125/1 061), the differences were both statistically significant ( χ2=19.11 and 16.28, respectively, both P<0.001). There was a significant difference in the pathogen spectrum of pulmonary infection before and during the epidemic ( χ2=128.91, P<0.001). There was a significant difference in the peripheral blood CD4 + T lymphocyte counts of patients with MTB, NTM, Pnenmocystis, Talaromycosis marneffei and Cryptococcus infection ( H=71.92, P<0.001). There were 63.74%(109/171) of Pneumocystis infection and 67.65%(69/102) of Talaromycosis marneffei infection occurred in patients with CD4 + T lymphocyte count<50/μL. Among the patients with pulmonary infection, the proportion of patients with adverse treatment outcomes during the epidemic was higher than that before the epidemic, and the difference was statistically significant (13.29%(141/1 061) vs 10.39%(152/1 463), χ2=5.04, P=0.025). Among the patients with pulmonary infection who developed adverse treatment outcomes, the top three pathogens (from high to low) were bacteria (63.48%(186/293)), mycobacteria (27.65%(81/293)), and fungi (6.83%(20/293)). The proportion of adverse treatment outcomes caused by bacterial infection decreased during the epidemic compared with that of before the epidemic (71.71%(109/152) vs 54.61%(77/141), χ2=9.23, P=0.002), while the proportion of adverse treatment outcomes caused by fungal infection increased (2.63%(4/152) vs 11.35%(16/141), χ2=8.74, P=0.003), and the differences were both statistically significant. The proportion of adverse treatment outcomes caused by mycobacterial infection increased, but without statistically significant (23.03%(35/152) vs 32.62%(46/141), χ2=3.37, P=0.066), among which there was no difference in the proportion of adverse treatment outcomes caused by MTB infection (13.82%(21/152) vs 14.89%(21/141), χ2=0.07, P=0.793), while the proportion of adverse treatment outcomes caused by NTM infection increased (5.92%(9/152) vs 14.89%(21/141), χ2=6.41, P=0.011). There was a significant difference in the pathogen spectrum of pulmonary infection patients with adverse treatment outcomes before and during the epidemic ( χ2=12.22, P=0.007). Conclusions:Among the spectrum of pathogens causing pulmonary infection and adverse treatment outcomes of HIV infection/AIDS patients during the epidemic, compared with that before the epidemic, the proportion of bacterial decreases, while the proportion of fungi increases, and the proportion of mycobacteria remains stable with the proportion of NTM increasing. The proportion of MTB causing pulmonary infection decreases, while the proportion of MTB causing adverse treatment outcomes remains stable.

Humans ; COVID-19 ; HIV Infections/drug therapy* ; Risk Factors

Humans ; HIV-1 ; Leukocytes, Mononuclear ; Lymphoma, Non-Hodgkin ; DNA ; HIV Infections

Objective:To analyze the clinical and epidemiological characteristics and changing trends of acquired immunodeficiency syndrome (AIDS)-associated talaromycosis in Shanghai City.Methods:The clinical data of patients with AIDS-associated talaromycosis hospitalized at Shanghai Public Health Clinical Center, Fudan University from Janauary 1, 2014 to December 31, 2021 were collected. The medical information included age, gender, place of origin, clinical symptoms, imaging manifestations, blood routine test, CD4 + T lymphocyte count. The chi-square test or Fisher exact probability test was used for statistical analysis. Univariate logistic regression was used to analyze the related risk factors for death. Results:From 2014 to 2021, a total of 12 165 AIDS patients were admitted, including 169 (1.4%) AIDS-assiociated talaromycosis patients. The proportions of AIDS-associated talaromycosis in AIDS inpatients from 2014 to 2021 were 1.8%(21/1 149), 1.1%(14/1 307), 1.3%(19/1 446), 0.9%(15/1 610), 1.2%(20/1 626), 1.2%(22/1 778), 1.7%(28/1 624) and 1.8%(30/1 625), respectively, which had not changed much. There was no statistically significant difference in the proportion of AIDS-associated talaromycosis in AIDS inpatients in different years ( χ2=9.50, P=0.218). Among the 169 patients, 157 cases (92.9%) were male, with the age of (37.9±12.2) years, and 35 were from Jiangxi Province, 31 from Shanghai Municipality, 29 from Zhejiang Province, 17 from Anhui Province, 14 from Fujian Province, 11 from Jiangsu Province, eight from Hunan Province, four from Heilongjiang Province, three cases each from Guangxi Zhuang Autonomous Region, Guizhou Province and Henan Province, two cases each from Hubei Province, Shandong Province, Shanxi Province, Yunnan Province and Guangdong Province, and one case from Chongqing Municipality. Patients from non-traditional endemic areas did not find a clear history of living in traditional endemic areas. Of 169 patients, 143(84.6%) cases had fever, 73(43.2%) had respiratory symptoms, and 26(15.4%) had rash during the course of the disease, 147(87.0%) had pulmonary imaging abnormalities, 94(55.6%) were complicated by other pathogens, and 44(26.0%) had hepatosplenomegaly, 137(81.1%) had CD4 + T lymphocyte count <50/μL. Twenty-three patients died, with the total fatality rate of 13.6%. The overall mortality rate showed a downward trend year by year. There was a statistically significant difference in the case fatality rate of AIDS-associated talaromycosis in different years (Fisher exact probability test, P=0.046). The result of univariate logistic regression model showed that patients with platelet count<50×10 9/L had an increased risk of death (odds ratio ( OR)=3.33, 95% confidence interval ( CI) 1.13 to 9.81, P=0.029). Conclusions:The overall change of AIDS-associated talaromycosis inpatients in Shanghai is not significant, while the prevalence rate has increased slightly in recent two years. The case fatality rate is declining year by year. The proportions of patients without a history of living in or traveling to epidemic areas and without rash as the first manifestation are high, and the main clinical manifestation is multi-system damage. Patients with platelet count<50×10 9/L have an increased risk of death.

Objective:To explore the clinical characteristics of acquired immunodeficiency syndrome (AIDS) complicated with nontuberculous mycobacteria (NTM) disease.Methods:The clinical data of 190 patients with AIDS complicated with NTM disease diagnosed by Shanghai Public Health Clinical Center, Fudan University from January 1, 2019 to December 31, 2021 were analyzed retrospectively. NTM diseases were divided into disseminated NTM disease group and non-disseminated NTM disease group. The independent sample t test, Mann Whitney U test and chi-square test were used for statistical analysis. Results:The 190 patients with AIDS complicated with NTM disease included 182 males and eight females. The age was (42±13) years old, and the first hospital stay was 15(6, 26) days. Pneumocystis carinii pneumonia was the most common co-infection in 12.1%(23/190) of patients, 87 cases (45.8%) were disseminated NTM disease. The clinical symptoms of patients were common in fever (55.8%(106/190)), cough (50.0%(95/190)), and expectoration (28.9%(55/190)). The proportions of fatigue (31.0%(27/87) vs 7.8%(8/103)), poor appetite (21.8%(19/87) vs 10.7%(11/103)) in the AIDS patients with disseminated NTM disease group were higher than those in the non-disseminated NTM disease group, and the differences were statistically significant ( χ2=16.99, P<0.001 and χ2=4.42, P=0.036, respectively). There was no significant difference in the proportions of deaths between AIDS patients with disseminated NTM disease and those without disseminated NTM disease (17.2%(15/87) vs 12.6%(13/103), χ2=0.80, P=0.371). The most common NTM species was Mycobacterium avium (67.1%(49/190)), followed by Mycobacterium kansasii (15.1%(11/190)). Hemoglobin ((90.3±23.9) g/L vs (110.1±24.2) g/L), albumin ((29.7±5.5) g/L vs (34.7±5.6) g/L), CD4 + T lymphocyte count (11(5, 30)/μL vs 52(16, 96)/μL) and CD8 + T lymphocyte count ((362±320)/μL vs (496±352)/μL) in the disseminated NTM disease group were lower than those in non-disseminated NTM disease group ( t=-5.63, P<0.001; t=-6.18, P<0.001; Z=-5.90, P<0.001; and t=-2.73, P=0.007, respectively), while procalcitonin (0.24(0.10, 0.77) μg/L vs 0.10 (0.04, 0.51) μg/L) was higher than that in the non-disseminated NTM disease group ( Z=-3.09, P=0.002), with statistical significance. The most common imaging features were lung patch and strip shadow (67.4%(128/190)). Conclusions:The most common type of AIDS patients complicated with NTM disease is disseminated NTM disease, and Mycobacterium avium is the most common NTM species. The clinical manifestations (fatigue, anorexia) and laboratory tests (hemoglobin, albumin, procalcitonin, CD4 + T lymphocyte count, CD8 + T lymphocyte count) of AIDS patients with disseminated NTM disease and non-disseminated NTM disease are different, while the prognosis is not significantly different.

Humans ; Cost-Benefit Analysis ; HIV Infections/drug therapy* ; Cost-Effectiveness Analysis ; Decision Trees

Objective:To investigate the diagnostic performance of Xpert Mycobacterium tuberculosis/rifampin (Xpert MTB/RIF) assay for pulmonary tuberculosis (TB) in patients with acquired immunodeficiency syndrome (AIDS). Methods:Clinical data of 226 patients with AIDS and suspected pulmonary TB in Shanghai Public Health Clinical Center, Fudan University from July 2017 to November 2019 were retrospectively analyzed. Fluorescence staining microscopy of sputum smear, BACTEC MGIT 960 liquid culture (or Roche solid culture) and Xpert MTB/RIF assay were implemented respectively. The sensitivity and specificity of Xpert MTB/RIF in the diagnosis of Mycobacterium tuberculosis (MTB) infection and rifampin resistance were analyzed. Results:Totally 226 patients of suspected pulmonary TB were enrolled. There were 94(41.6%) patients had positive mycobacterium culture, in which 51 (54.3%) were MTB and 43 (45.7%) were nontuberculous mycobacteria (NTM). Using the positive MTB culture of sputum and mycobacterial protein from BCG of Rm 0.64 in electrophoresis (MPB64) as reference standard, the sensitivity and specificity of Xpert MTB/RIF assay for MTB diagnosis were 72.6%(95% confidence interval ( CI) 66.7%-78.4%) and 97.1% (95% CI 95.0%-99.3%), respectively. The sensitivity and specificity of Xpert MTB/RIF assay for MTB diagnosis in patients with positive sputum smear were 76.7%(95% CI 67.7%-85.8%) and 90.0(95% CI 83.6%-96.5%), respectively. The sensitivity and specificity of Xpert MTB/RIF assay for MTB diagnosis in patients with negative sputum smear were 50.0%(95% CI 41.8%-58.2%)and 99.3%(95% CI 97.9%-100.0%), respectively. With phenotypic resistance as reference standard, the sensitivity and specificity of Xpert MTB/RIF assay for rifampicin resistance were 75.0% and 100.0%, respectively. Conclusion:Among AIDS patients, the performance of Xpert MTB/RIF assay for pulmonary TB diagnosis is pretty good and could differentiate MTB from NTM rapidly, which has good application value.

To investigate the clinical characteristics of metastatic hormone sensitive prostate cancer and explore the strategy of combination of new endocrine drugs.In April 2019, an 69-year-old man was admitted to the First People’s hospital of Changzhou with "gross hematuria" . Physical examination showed prostatic hyperplasia with an unsmooth hard surface. CT showed a mass in bladder and possible metastasis in right lung. Diagnostic TUR-Bt pathology showed prostatic acinar adenocarcinoma, and PET-CT showed malignant lesion of prostate with bladder invasion, multiple pelvic lymph node metastasis and lung metastasis. The diagnosis of mHSPC with lymphatic and lung metastasis was considered. The patient was treated with bicalutamide and then switched to goserelin plus acetate abiraterone with prednisone. Total prostate specific antigen (tPSA) decreased to 0.705 ng/ml after 1 month of ADT+ AAP treatment, and decreased to 0.007 ng/ml after 4 months, and then maintained at 0.003 ng/ml until January 2021. Serum testosterone decreased to 0ng/dl and maintained the whole follow-up period. After 3 months of treatment, the pulmonary metastasis was not obvious. Till the last follow-up at January 2021, the patient reported good quality of life with no serious adverse events. The efficacy of ADT combined with acetate abiraterone in the treatment of mHSPC with lung cancer was significant.

Objective:To study the distribution of pathogenic microorganisms in the ocular fluid of patients with acquired immunodeficiency syndrome (AIDS) and infectious uveitis.Methods:It was a retrospective case analysis. From June 2018 to December 2019, 31 AIDS patients with infectious uveitis who were hospitalized or outpatient at Shanghai Public Health Clinical Center were included in the study. Among them, there were 30 males and 1 female; the average age was 38.51±11.17 years. There were 20 cases of panuveitis, 10 cases of posterior uveitis, and 1 case of infectious endophthalmitis. Serum CD4 +T lymphocyte count (CD4 +TC) were 0 - 239/μl during the same period. The second-generation gene sequencing technology was used to detect the collected intraocular fluid. Among 31 specimens, aqueous humor and vitreous humor were 27 and 4 respectively. Results:Among 31 specimens, 18 samples (58.1%, 18/31) of cytomegalovirus (CMV) were detected; varicella-zoster virus (VZV) were detected in 5 samples (16.1%, 5/31); Epstein-Barr virus were detected in 9 samples (29.0%, 9/31); human beta herpes virus type 6 (HHV6) were detected in 3 samples (9.7%, 3/31), human papillary molluscum virus (HPV), human polyoma virus, type G hepatitis virus were separately detected in 1 sample (3.2%, 1/31), all coexisting with other microorganisms. Parvovirus were detedcted in 8 samples (25.8%, 8/31); treponema pallidum were detedcted in 5 samples (16.1%, 5/31); toxoplasma gondii and Harmon coccidia were detedcted in 1 sample (3.2%, 1/31); synitelium Polycarpum were detedcted in 1 sample (3.2%, 1/31); mycobacterium tuberculosis complex, fungi, and microbacteria coexist were detedcted in 1 sample (3.2%, 1/31). Among the 18 CMV specimens, the number of gene sequences was more than 1059 (50.0%), and 104-1055 (27.7%). Among the 5 specimens of VZV, the number of gene sequences was>1044 (80.0%). In one specimen, the mycobacterium tuberculosis complex, fungi, and microbacteria coexist, and the number of gene sequences were all <100. The number of gene sequences of HHV6, HPV, human polyoma virus, type G virus, and parvovirus in all specimens was small. Among 31 specimens, 15 (48.4%) of pathogenic microorganisms were detected at least 2 species.Conclusions:CMV and VZV are the main pathogenic microorganisms of infective uveitis in patients with serum CD4 +TC <100/μl; treponema pallidum, toxoplasma gondii or other protozoa, mycobacterium tuberculosis, and fungi cause more infectious uveitis which are common in AIDS patients with serum CD4 +TC >100/μl. The coexistence of two or more microorganisms can be detected in the intraocular fluid of AIDS patients with infectious uveitis.