Current Issue

2019 Vol.4 No.2 Published:30 June 2019

Guidelines and Consensus

Chinese guidelines for diagnosis and treatment of HIV/AIDS (2018) 2019, 4 (2):  65-84.  Abstract ( 719)    PDF (942KB) ( 433 )    Acquired immunodeficiency syndrome (AIDS) is an important public health problem in China. In 2005, the first edition of the guidelines for the diagnosis and treatment of AIDS was formulated by the AIDS Professional Group of Society of Infectious Diseases of Chinese Medical Association, which was updated in 2011 and 2015, respectively. The fourth edition of the guidelines in 2018 is revised on the basis of the third edition and updated according to national clinical practice and the latest research results. The new research progress in opportunistic infections and human immunodeficency virus(HIV) associated cancers, antiretroviral therapy, HIV post-exposure prophylaxis, and prevention of mother to child transmission were updated in these guidelines. In the 2018 edition, pre-exposure prophylaxis is mentioned for the first time. The strategy of whole course management of HIV infection is put forward and how to do the whole course management of HIV infection is explained in this version. These guidelines will be updated regularly according to the latest clinical evidence.

Forum of Specialist

The potential clinical value of Biktarvy® in HIV treatment in China WANG Hui 2019, 4 (2):  85-90.  Abstract ( 433)    PDF (837KB) ( 1029 )    Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide), a new integrase strand transfer inhibitor (INSTI)- based single tablet regimen (STR), has been recommended as a first-line antiretroviral therapy (ART) by European and American guidelines in 2018. It has also been recommended by American guidelines as one of the first-line options for rapid initiation of ART. Biktarvy® a good safety profile and a high resistance barrier in clinical trials is demonstrated non-inferior efficacy to existing first-line ART regimens, a good safety profile and a high resistance barrier in clinical trials. It has been approved and used clinically in the European Union (EU), the United States of America (USA) and some regions in Asia. This paper reviews the efficacy and safety data from Biktarvy’s pivotal trials, and discusses the potential clinical significance of this novel regimen for the treatment of Chinese patients with human immunodeficiency viruses (HIV) infection.

Original Articles

The role of CD4/CD8 ratio in predicting clinical outcomes in human immunodeficiency virus(HIV) infected patients WANG Si-yuan, SUN Li-qing, DUAN Si-qin, SONG Ying, RAO Man, ZHOU Yang 2019, 4 (2):  91-96.  Abstract ( 371)    PDF (960KB) ( 1406 )    Objcetive To investigate the role of CD4/CD8 ratio in predicting clinical outcomes in Human Immunodeficiency Virus(HIV) infected Patients with newly antiretroviral treatment(ART).Method Total of 11357 HIV infected patients with newly ART admitted during January 1982 to October 2018 in Shenzhen the Third People's Hospital were analyzed, retrospectively. 10,522 subjects were included in the study due to exclusion of subjects with incomplete information. The clinical characteristics and levels of CD4/CD8 ratio were collected. According to the tertiles of CD4/CD8 ratio [0-0.20, 0.20-0.40 (reference), >0.40], the patients were divided into three groups: CD4/CD8 ratio <0.2 group (3535 cases) , 0.2≤CD4/CD8 ratio <0.4 group (4410 cases)and CD4/CD8 rati≥0.4 group (2577 cases).Result s Of the 10522 subjects, mean age ± Standard Deviation(SD) was (33.64 ± 10.34) years ,mean CD4+T-cells ± SD was (246.96±160.26)cells/mm3,mean CD8+T-cells ± SD was (898.69 ± 523.28) cells/mm3 and mean CD4/CD8 ratio ± SD was (0.30 ± 0.24). Based on multivariate linear regression analysis, factors associated with the CD4/CD8 ratio were gender,（t-tests 4.135, 95% CI: 0.017~0.046, P<0.001）,opportunistic infections（t-tests -21.609, 95% CI: -0.103~-0.086, P<0.001）, clinical stages of HIV infection with the WHO classification（t-tests -38.782, 95% CI: -0.092~-0.083, P<0.001）,time between HIV diagnosis and ART initiation（t-tests -2.904, 95% CI: -0.022~-0.004, P<0.001） and HIVRNA loads（t-tests -16.385, 95% CI:-0.047~-0.037, P<0.001）. The CD4/CD8 ratio in multivariate analysis was not associated with age (t-tests -1.006, 95% CI: -0.001~-0.000, >0.05), body mass index (t-tests -1.161, 95%CI: -0.002~-0.001, >0.05), and deaths (t-value 0.058, 95% CI: -0.044-0.047, >0.05).Conclusions In this large cohort collaboration, the lower CD4/CD8 ratio in HIV-infected patients with newly ART was associatde with the longer time between HIV diagnosis and ART initiation ,the later clinical stages of HIV infection with the WHO classification and the higher HIVRNA loads,which indicated that more opportunistic infections. This large study showed the use of CD4/CD8 ratio can be used as a prognostic marker for clinical progression of opportunistic infections.

Comparison of amphotericin B deoxycholate, amphotericin B liposome and voriconazole as induction treatment on HIV-related cryptococcal meningitis TAO Ran, SHI Jin-chuan, GUO Yong-zheng, XU Li-jun, CHEN Ying, LOU Fang-yuan, HUANG Ying, XU Yan, ZHU Biao, CHEN Yao-kai, YU Jian-hua 2019, 4 (2):  97-102.  Abstract ( 430)    PDF (877KB) ( 809 )    Objective To compare clinical effects between amphotericin B deoxycholate (AmB) + 5 fluorocytosine (5FC) ± fluconazole (Flu), amphotericin B liposome (LipAmB) + 5FC and voriconazole (Vori) + 5FC as induction treatment on HIV-related cryptococcal meningitis.Methods A retrospective cohort study was performed to compare the side effects and 10-week cumulative survival rates in 85 HIV- related cryptococcal meningitis patients who treated with AmB + 5FC ± Flu, LipAmB + 5FC or Vori + 5FC as induction regimens from 2010 to 2017.Result sThe incidences of hypokalemia and creatinine elevation were higher in the AmB + 5FC ± Flu group than in Vori + 5FC group (P=0.016, P=0.047, respectively), but no statistical significance was found in LipAmB + 5FC group vs. Vori + 5FC group, and AmB + 5FC ± Flu vs. LipAmB+5FC group. The 10-week cumulative survival rate of patients was 96.6%, 85.5%, and 76.2% in LipAmB + 5FC group, AmB + 5FC ± Flu group and Vori + 5FC, respectively (Log-Rank P=0.093), and the 10-week cumulative survival rate of patients in LipAmB + 5FC group was higher than those in Vori + 5FC group (Log-Rank P=0.022).Conclusion The Vori + 5FC as induction therapy is not superior to the AmB + 5FC ± Flu or LipAmB + 5FC regimen, but related with less side effects. LipAmB + 5FC as induction therapy is not inferior to the AmB + 5FC ± Flu regimen.

Analysis of plasma efavirenz concentration and related factors in HIV/AIDS patients ZHAO Fang, LI Wei, ZHEN Yi, LIU Xiao-ning, ZHOU Yang, ZHANG Lu-kun, PENG Qiao-li, Wang Hui, He Yun 2019, 4 (2):  103-107.  Abstract ( 520)    PDF (1061KB) ( 1113 )    Objective To investigate the relationship between plasma drug concentration and adverse reactions after taking efavirenz (EFV) standard dose (600mg) in HIV/AIDS patients, and to explore the factors affecting drug concentration, so as to provid basis forrational dose adjustment of EFV.Methods Total of 333 HIV-infected outpatients in Shenzhen the third people's hospital were enrolled (receiving EFV>3 months and viral load <500copies/ml).General demographic and clinical information were collected by patient interview. The plasma concentration of EFV in the patient's plasma was measured by high performance liquid chromatography and the clinical information of the patient was collected. The concentration and adverse drug reactions of EFV and the associated factors were analyzed by SPSS.Result sThe median plasma EFV concentration in the Han population of Shenzhen was 3.3 mg/L, the interquartile range (Q1 2.5, Q3 4.3). Among them, 229 (68.4%) were in the optimal therapeutic concentration window (1~4mg/L), 4 (1.2%) were less than 1mg/L, and 100 (30.3%) were greater than 4mg/L. Multivariate analysis showed that weight ≤60Kg and BMI≤22 Kg/m2 were significantly associated with EFV plasma concentrations greater than 4 mg/L. Exception of the dizziness symptom, there was no significant association between other adverse events of EFV and the highplasma EFV concentration greater than 4 mg/L.Conclusion The plasma EFV concentration in the Han population of Shenzhen is high, and BMI and body weight can better reflect the blood concentration. Therefore, dose adjustment of EFV can be performed based on BMI or body weight..

A case report of suspected lung cancer associated with HIV infection and pulmonary nodule shadow and literature review MA Cai-hua, LV Wei 2019, 4 (2):  108-111.  Abstract ( 850)    PDF (1197KB) ( 1124 )    Objective To explore the importance of the clinical differential diagnosis of HIV infection with pulmonary nodules and other space-occupying lesions.Methods This paper reported the diagnosis and treatment of a patient with HIV infection complicated with pulmonary nodule shadow from suspected lung cancer to clinically confirmed pulmonary tuberculosis, and reviewed relevant literature.Result sA patient with confirmed HIV infection was admitted to the outpatient department due to fever. Subpleural nodules of the dorsal segment of the lower lobe of the left lung were observed on lung CT. PET-CT indicated a high possibility of malignant lesions, and biopsy of the lesion tissue suggested chronic inflammation. Clinical consideration of tuberculosis may be given empirical anti-tuberculosis treatment, anti-retrovirus treatment, and regular follow-up review of the chest CT. Visible nodule shadow smaller than before may be obserced. Patients were followed up for stable conditions.Conclusion Among patients with HIV infection complicated with pulmonary nodules, it is necessary to carefully identify benign and malignant lesions so as to make a correct judgment as early as possible and avoid misdiagnosis and treatment.

Experimental study on Clonorchis sinensis infection induced biliary duct injury and hepatic fibrosis FANG Jing, ZHOU Zhong-yang, LIAO Jin-yuan 2019, 4 (2):  112-116.  Abstract ( 272)    PDF (1809KB) ( 885 )    Objective To explore the difference of bile duct and hepatocyte damage caused by different doses of Clonorchis sinensis infection in rabbits, and to provide reference for the establishment of models.Methods The metacercarias of clonorchis sinensis were extracted by artificial digestion, collected and counted under microscope. 400, 600 and 800 metacercarias were given to 15 rabbits by oral in 3 groups named low-degree, medium-degree and high-degree infected group, normal saline was given to 5 rabbits which were served as control group. All rabbits were sacrificed after 90 days and the liver specimens were performed with pathological examination.Result sRabbits in 3 infected groups were all infected successfully. Egg positive rates in feces reached 100% in 4 weeks post infection. The highest adult Clonorchis sinensis recovery rate in low, medium and high infected-groups were 20.50%,15.17% and 23.38%. There was no statistical difference in the number of adults between the low and medium infection groups（P=0.24）,the comparison of number of adults between low and medium infected-groups with high infected-group showed significant differences（P<0.01）. The rabbit liver in the infected group was found that biliary ducts in the liver were thickened significantly, and a large number of live adult Clonorchis sinensis were found in the intrahepatic bile ducts and gallbladder; Observed with light microscope, the portal area was enlarged with collagen accumulation, the intrahepatic bile duct was thickened, the bile duct wall was thickened, the bile duct and surrounding tissues were inflamed, and low to high level intraepithelial neoplasia was observed in the endothelium of the bile duct. Masoon trichromic staining was observed and stage of fibrosis was quantified according to the Metavir scoring system -- liver fibrosis staging score. In the control group, 5 rabbits were all in the stage of F0 (no liver fibrosis), while in the infected group 2 were in the stage F1, 4 were in the stage F2, and 4 were in the stage F3, There was statistical difference in the stage of fibrosis between low and high infection groups（P<0.05）.Conclusions Infection for 90 days, the best recommended dose for Clonorchis sinensis infection model in rabbit is 600 metacercarias, it was suitable to the requirements for experimental model as biliary duct injury and hepatic fibrosis.

Development and validation of prognostic models for tuberculosis patients with drug-induced liver injury HE Jun-qi, ZHANG Li-min, GUO Yan-hong 2019, 4 (2):  117-120.  Abstract ( 251)    PDF (877KB) ( 801 )    Objective To develop and validate prognostic models for tuberculosis patients who had the fixed dose compound preparation with drug-induced liver injury.Methods The clinical data of 208 patients with drug-induced liver injury were collected to develop prognostic models．The patients were randomly divided into the modeling sampling group (n=156)and the validation sampling group (n=56). Modeling sampling were used for univariate and Logistic regression analysis to identify factors related with drug-induced liver injury. According to univariate and Logistic regression analysis results, a prognostic model was established. The validation sampling was used to compute the accuracy, sensitivity and specificity of the prognostic models.Result Logistic regression analysis revealed that living environment,working environment and the diagnose result were independent risk factors for drug-induced liver injury．The prognostic model based on the risk factors of admission had favorable performance (P>0.05 for Partial chi square test,0.884 for AUC). The accuracy of the prognostic model was 84.6%, sensitivity was 55.56% and specificity was 93.02%.Conclusion The established model,which is convenient to manage,can timely and accurately predict the prognosis of tuberculosis patients with drug- induced liver injury,and can help in decision-making in clinics.

Review

Post exposure prophylaxis for human immunodeficiency virus (HIV) WANG Fang, ZHANG Fu-jie 2019, 4 (2):  121-124.  Abstract ( 235)    PDF (872KB) ( 1072 )    Persons with exposure to blood, genital secretions, or other potentially infectious body fluids that might contain human immunodeficiency virus (HIV) in or outside health care settings may face the risk for HIV acquisition.Post exposure prophylaxis (PEP) is indicated for exposed persons without HIV infection. All persons offered PEP should be prescribed a 28-day course of a 3-drug antiretroviral regimen within 72 hours after exposure. Antiretrovirals that effectively suppress viral replication with good tolerance and convenience are recommended for PEP. 2NRTIs and 1INSTI are preferred. Evaluations including HIV Ag/Ab and monitor of safety or toxicities related to the regimen prescribed are required.

Education Fields（Video）

How should clinicians understand Chinese guidelines for diagnosis and treatment of HIV/AIDS (2018) HE Yun 2019, 4 (2):  125-128.  Abstract ( 410)    PDF (821KB) ( 749 )    In order to better improve the level of diagnosis and treatment of AIDS in China, standard diagnosis and treatment behavior, constantly update the " Chinese guidelines for diagnosis and treatment of HIV/AIDS" (hereinafter referred to as the "guidelines") is the main task of the HIV/AIDS and Hepatitis C group of the infectious diseases branch of the Chinese Medical Association. The first edition, written in 2005, has been updated four times. The "guideline”updated in 2018, combined with China's actual situation to a great extentandwith reference to international guidelines, fully provides clinical research of China's scientific research conclusions and evidence-based medical evidence.This guideline with Chinese characteristics is in line with international standards in the fields of laboratory diagnosis, clinical staging, antiviral treatment programs, special populations, prevention and prevention pre- and post-exposure, and comprehensive medical care for HIV/AIDS patients., At the same time, it reflects less completion time, more comprehensive content and more scientific concept and is the preferred reference guide for the first-line medical workers in China.