背景：

艾滋病，即获得性免疫缺陷综合征，目前在全世界约有3700万人感染人类免疫缺陷病毒（Human immunodeficiency virus ,HIV），约有2.57亿人群遭受慢性乙肝病毒(hepatitis B virus，HBV)感染，由于HIV和HBV有共同的感染途径，因此HIV和HBV常合并感染，共感染的患者有更高的风险进展为肝硬化、肝衰竭及肝细胞癌，共感染的研究对于疾病的防控具有重要的意义。目前HIV感染者合并HBV感染的患病率及其疾病特征的研究缺乏，国际上评价HIV/HBV共感染患者慢性HBV感染的治疗效果的研究甚少。

目的：

1. 计算北京地区HIV/HBV共感染的患病率；

2. 计算2013-2018年年新诊断HIV感染者中HBV的感染率，分析其变化趋势；

3. 通过Logistic逻辑回归模型分析HIV/HBV共感染患者的临床特征与共感染之间的相关性；

4. 研究HIV/HBV共感染者在不同ART方案下的HBsAg清除率及HBeAg抗原转换率。

对象和方法：

1.研究对象：2001年8月至2019年6月，在北京地区HIV/AIDS定点治疗医院（北京协和医院、首都医科大学附属地坛医院、首都医科大学附属佑安医院）长期随访及治疗，且年龄＞18岁的HIV感染患者。

2.研究方法：

Ÿ   流行病学调查研究：回顾性分析北京地区HIV/AIDS定点治疗医院的HIV感染者的临床资料，包括性别、年龄、婚姻状况、感染途径等，基线乙肝五项检测结果。

Ÿ   血标本采集及血清学检测：包括常规生化指标、T细胞亚群、HIV病毒载量、回顾性分析过去数年诊断的HIV感染者基线乙肝五项结果，明确每年新诊断HIV感染者中HIV/HBV共感染率及其年变化趋势。

Ÿ   明确北京地区HIV/HBV共感染的影响因素：根据患者的年龄、性别、婚姻状态、CD4+T细胞计数、所接受的抗病毒治疗方案分别做分层分析，明确不同因素对于新发感染的影响。

Ÿ   评价不同方案ART治疗对于HIV感染者慢性HBV感染的疗效分析：根据目前的队列中HIV/HBV共感染者ART方案中包含的抗HBV感染的药物不同，将患者分组单3TC组，3TC+TDF组，收集或检测不同组患者目前方案治疗1年时的HBsAg、HBeAg、HBV DNA载量结果，明确不同ART方案的HBsAg清除率、HBeAg抗原转换率以及HBV DNA抑制率。

Ÿ   统计分析：对数据进行整理后，应用SPSS(23.0)进行统计分析。

结果：

1.  在长期随访的13253例HIV/AIDS感染者中，11572例患者纳入研究，其中HIV/HBV共感染患者532例（4.6%）。在共感染患者的人群中85.9%为青壮年(28-49岁)男性，感染途径以同性性传播为主(74.8%)。

2.  2013-2018年，HIV/HBV共感染的年新增感染率呈波动性下降的趋势，年均增长率分别为 6.37%，4.55%，3.92%，4.68%，4.24%，2.74%。

3.  HIV/HBV共感染的主要影响因素为年龄（28-48岁与＜28岁比较，OR=2.807,95%CI:1.241-6.345）以及婚姻（已婚与未婚比较，OR=1.259, 95%CI:1.004-1.579）。

4.  87.4%的共感染患者基线治疗接受了包含拉米夫定(3TC)、替诺福韦(TDF)两种抗HBV药物的治疗。在共感染患者的治疗过程中，1年后3TC+TDF组的HBeAg抗原丢失率为46.4%（39/84），抗原转换率为39.3%。3TC+TDF组相较于3TC组趋于更高的抗原转换率，也有更高的病毒抑制率。

结论：

北京地区HIV/HBV共感染率为4.6%，比2016年全国的平均共感染率低；2013-2018年，HIV/HBV年新增共感染率呈波动性下降趋势。本研究所调查的多种临床危险因素，中青年（28-48岁）已婚的HIV患者有更高的风险合并HBV感染，未发现其他危险因素与共感染的相关性。3TC+TDF组相较于3TC组趋于更高的抗原转换率，也有更高的病毒抑制率。在共感染患者的诊治随访中，需进一步加强对肝肾功能、HBV抗原、HBV DNA的监测。

Background

AIDS, that is, acquired immunodeficiency syndrome, about 37 million people worldwide are infected by human immunodeficiency virus (Human immunodeficiency virus, HIV) currently.  At the same time, about 400 million people suffer from chronic hepatitis B virus (hepatitis B virus, HBV) infection.  Because HIV and HBV share a common route of infection, HIV and HBV are often co-infected.  Patients with HIV/HBV co-infection are more likely to develop liver cirrhosis and hepatocellular carcinoma.  It is an important issue in the prevention and control of infectious diseases.  At present, the research on the prevalence and disease characteristics of HIV infection co-infected with HBV is rare, and there are few international studies to evaluate the functional cure of chronic HBV infection in patients with HIV/HBV co-infection. The study of HIV/HBV co-infection is of great significance for the prevention and control of the disease.

Objective

Calculating the prevalence of HIV/HBV co-infection in Beijing distract.

Calculating the prevalence of HIV/HBV co-infection among newly diagnosed HIV infections from 2013 to 2018 and analyze the trend of annual rate.

Logistic regression model was used to analyze the correlation between clinical characteristics and co-infection in patients with HIV/HBV co-infection.

Analyzing the HBsAg clearance rate and HBeAg antigen conversion rate of HIV/HBV co-infected patients under different ART regimens.

Subjects and methods:

Subjects: patients with HIV infection were followed up and treated in Beijing HIV/AIDS designated treatment Hospital (Peking Union Medical College Hospital, Beijing Ditan Hospital and Beijing You' an Hospital) from 2001 to 2019.

Research methods:

Epidemiological investigation: We analysed retrospectively the clinical data of HIV infected persons in HIV/AIDS designated treatment hospitals in Beijing, including sex, age, marital status, route of infection, and the baseline results of tests for HBV replication (hepatitis B e antigen [HBeAg], antibody to HBeAg [anti-HBe], HBV DNA).

Collection of blood samples and Laboratory tests：including liver chemistry tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT]), T lymphocyte subsets, HIV virus load.  Besides, we analyzed retrospectively the tests for hepatitis B in HIV patients diagnosed in the past few years, and to determine the annual prevalence of HIV/HBV co-infection and its trend in newly diagnosed HIV infection.

Identifying the influencing factors of HIV/HBV co-infection in Beijing: stratified analysis was made according to the patient's age, sex, marital status, CD4+T cell count and antiviral treatment regimen to determine the impact of different factors on HIV/HBV co-infection.

Evaluating the efficacy of different ART regimens in the treatment of chronic HBV infection in patients with HIV infection: according to the different anti-HBV drugs included in the ART regimen for HIV/HBV co-infection in the cohort, the patients were divided into two groups: single 3TC group and 3TC+TDF group.  The results of HBsAg, HBeAg and HBV DNA load in different groups were collected or detected to determine the HBsAg clearance rate, HBeAg antigen conversion rate and HBV DNA inhibition rate of different ART regimens.

Statistical analysis: After sorting out the data, SPSS (23.0) was used for statistical analysis.

Results

In the long-term follow-up of 13253 cases of HIV/AIDS infection, 11572 patients were included in the study, of which 532 cases (4.60%) were co-infected with HIV/HBV.  85.9% of the coinfected patients were young and middle-aged (28-48 years old) male, and the main route of infection was homosexual transmission (74.8%).

From 2013 to 2018, the prevalence of HIV/HBV co-infection showed a fluctuating downward trend, with an average annual growth rate of 6.37%, 4.55%, 3.92%, 4.68%, 4.24% and 2.74%, respectively.

The main influencing factor of HIV/HBV co-infection was age (28-48 years old vs＜28 years old, OR=2.938, 95%CI:1.300-6.640) and marriage (married versus unmarried, OR=1.259, 95%CI:1.004-1.579).

87.4% of the patients with co-infection received baseline treatment with two anti-HBV drugs, lamivudine (3TC) and tenofovir (TDF). During the follow-up, the HBeAg antigen loss rate and antigen conversion rate in the 3TC+TDF group were 46.4% and 39.3% respectively at 1 year of treatment. Compared with 3TC group, 3TC+TDF group tends to have higher antigen conversion rate and higher virus inhibition rate.

Conclusion

The prevalence of HIV/HBV co-infection in Beijing was 4.6%, slightly lower than the prevalence of national average of 12 provinces in 2013; the prevalence of the HIV/HBV co-infection showed a fluctuating downward trend from 2016 to 2018. Among the many clinical risk factors investigated in this study, age (28-48 years old)and marriage had a higher risk of co-infection, and no correlation between other risk factors and co-infection was found.  Compared with 3TC group, 3TC+TDF group tends to have higher antigen conversion rate and higher virus inhibition rate.Attention should be paid to the high-risk population, early prevention and strengthening the monitoring of liver function.