Changes in blood lipid levels and influencing factors among treatment-naïve adult male HIV/AIDS patients following BIC/FTC/TAF vs . 3TC+EFV+TDF.

BACKGROUND: Antiretroviral therapy (ART) was often associated with dyslipidemia among human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients. This study aimed to assess treatment-naïve adult male patients with HIV/AIDS who initiated ART with either co-formulated bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) or lamivudine, efavirenz, and tenofovir disoproxil fumarate (3TC+EFV+TDF), monitoring at weeks 4, 12, 24, and 48. METHODS: A case-control retrospective study was conducted. The newly diagnosed HIV-infected individuals attending the sexual transmission disease (STD)/AIDS clinic of Beijing Youan Hospital, Capital Medical University, from January to December 2021. The patients were divided into BIC/FTC/TAF group or 3TC+EFV+TDF group. High-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and total cholesterol (TC) at different time points over 48 weeks between two groups were compared. A multivariate Cox regression model was used to identify relevant influencing factors for the population at high risk of increased LDL-C. RESULTS: A total of 870 participants, with 510 in BIC/FTC/TAF group and 360 in 3TC+EFV+TDF group. There were no statistically significant differences in median age, baseline CD4/CD8 ratio, median body mass index (BMI) between the two groups. In both two groups, levels of TG, TC, and LDL-C were higher at 4 weeks, 12 weeks, and 24 weeks of treatment (all P <0.05), and there were no statistically significant differences at 48 weeks compared to those at baseline (all P >0.05). In addition, the differences in average changes of the level of TG, TC, HDL-C, and LDL-C from weeks 4, 12, 24, and 48 to baseline between two groups were not statistically significant (all P >0.05). Multivariate Cox proportional risk model analysis showed that initiating ART with HIV RNA ≥10 5 copies/mL (compared with <10 5 copies/mL) was associated with an increased risk of elevated LDL-C (hazard ratio = 1.26, 95% confidence interval: 1.07-1.48, P  = 0.005). CONCLUSIONS: Transient elevations in blood lipid levels (TC, TG, HDL-C, and LDL-C) were observed in treatment-naïve adult male HIV/AIDS patients with BIC/FTC/TAF at 4 weeks, 12 weeks, and 24 weeks of treatment. However, these levels did not differ significantly from baseline after 48 weeks of treatment, regardless of whether patients were in the BIC/FTC/TAF or 3TC+EFV+TDF group.

Loss to follow-up among human immunodeficiency virus-positive postpartum women and its predictive factors: A retrospective study.

OBJECTIVES: Antiretroviral treatment (ART) is essential in preventing mother-to-child transmission of human immunodeficiency virus (HIV), and postpartum discontinuation of ART is associated with adverse outcomes. This study identified factors associated with postpartum follow-up of HIV-positive women. METHODS: This was a retrospective cohort study of 170 HIV-infected pregnant women who received regular obstetric examination and delivered successfully in Beijing between 2003 and 2020.The women's sociodemographic, clinical, treatment, obstetric, and gestational characteristics were analyzed. Cox proportional hazards models were used to estimate adjusted hazard ratios (AHRs) of loss to follow-up between levels of confounders. RESULTS: In the multivariable Cox proportional hazard models, women with a longer time from HIV diagnosis to delivery per year had a 1.4-timeshigher risk (AHR = 1.433, 95% CI: 0.897-2.229) and a higher rate of loss to follow-up than the other women. Perinatal health care (AHR = 0.003,95% CI: 0.000-0.105) and gestational age above 37 weeks at delivery (AHR = 0.294, 95% CI: 0.005-15.818) were associated with a longer follow-up of postpartum HIV-positive women, when compared to women who did not receive perinatal healthcare and who delivered before 37 weeks of gestation, respectively. CONCLUSIONS: The longer time from HIV diagnosis to delivery, access to perinatal care, and full-term gestation at delivery improved postpartum ART adherence and follow-up among HIV-positive women. Early initiation of ART, integration of adult ART into prevention of mother-to-child transmission, combination ART with maternal healthcare, and enhanced pregnancy care will improve ART adherence among HIV-positive women after delivery.

An open-label evaluation of safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide for post-exposure prophylaxis following potential exposure to human immunodeficiency virus-1.

BACKGROUND: Single-tablet regimen (STR) provides a convenient once-daily regimen for the prevention of human immunodeficiency virus (HIV) infection. Here, we investigated the safety and tolerability of coformulated bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as a three-drug, STR for post-exposure prophylaxis (PEP) in Chinese individuals. METHODS: This was a prospective, open-label, single-arm trial conducted in a sexually transmitted diseases and acquired immunodeficiency syndrome clinic of a tertiary hospital in Beijing, China. Adults requiring PEP were prescribed BIC/FTC/TAF one pill once a day for 28 days. Clinical and laboratory data were collected and analyzed at baseline, weeks 2, 4, 8, 12, and 24. RESULTS: Of 112 participants enrolled in the study, 109 (97.3%) were male and the mean age was 30 ±â€Š8 years. PEP completion was 96.4% (95% confidence interval: 91.1-99.0%). Two participants stopped PEP after 2 days because the source partner was identified as HIV uninfected. One participant was excluded due to hepatitis B virus infection according to the exclusion criteria. One discontinued due to the participant's decision. No participant acquired HIV through week 24. Adherence was 98.9% (standard deviation [SD]: 3.3%) by self-reporting and 98.5% (SD: 3.5%) by pill count. Only five participants experienced mild clinical adverse events attributed to the study drug (including headache, diarrhea, and nausea) and four participants had elevated serum creatinine (grade 1). CONCLUSIONS: A once daily, STR of BIC/FTC/TAF used as PEP was safe and well-tolerated with a high rate of completion and adherence in Chinese. BIC/FTC/TAF may be a good option for PEP. TRIAL REGISTRATION: ChiCTR.org.cn, ChiCTR2100048080.

Clinical characteristics, diagnosis, and predictors of neurosyphilis patients with human immunodeficiency virus co-infection: A retrospective study at infectious diseases hospitals in two cities of China.

ABSTRACT: This study aimed to compare between the clinical and laboratory characteristics of neurosyphilis and those of syphilis in human immunodeficiency virus (HIV) positive and explore the risk factors associated with the occurrence of neurosyphilis in the HIV infected.In-patients diagnosed with HIV and syphilis co-infection who underwent a lumbar puncture and completed cerebrospinal fluid (CSF) examination were divided into neurosyphilis group and syphilis group. The demographic characteristics, symptoms and signs, and laboratory tests of the 2 groups were comparatively analyzed. Logistic regression analysis was used to explore the risk factors associated with the occurrence of neurosyphilis.Among 81 patients, 33 patients were assigned to the neurosyphilis group, and 48 to the syphilis group. There were no significant differences in the age, gender, marital status, acquired immunodeficiency syndrome course, opportunistic infections, serum HIV viral load, and history of syphilis treatment. The difference in HIV transmission route between the 2 groups was statistically significant (P = .010), and the patients from the neurosyphilis group were mainly infected via heterosexual contact. The proportion of serum toludine red unheated serum test (TRUST) titer ≥1:16 in the neurosyphilis group were 78.8%, which was significantly higher compared to the syphilis group (48.9%). The level of CSF white blood cell count, CSF protein, and CSF HIV viral load in the neurosyphilis group were significantly higher than those of the syphilis group. The proportion of patients with neurological symptoms and signs in the neurosyphilis group was significantly higher compared to the syphilis group (P < .001). Multivariate logistic regression analysis showed that heterosexual contact transmission route, not received antiretroviral therapy, lower CD4 cell count and higher serum TRUST titer, untreated with syphilis, and neurological symptoms and signs were risk factors associated with the occurrence of neurosyphilis.The serum TRUST titer, CSF white blood cell count, CSF protein level, CSF HIV viral load, and the percentage of neurological symptoms and signs in the neurosyphilis group were higher. Heterosexual transmission route, not received antiretroviral therapy, and untreated with syphilis prompted the possibility of neurosyphilis occurrence.

Service acceptance of HIV non-occupational post-exposure prophylaxis(nPEP) among college students: a cross-sectional study in China.

BACKGROUND: College students were the key group we should pay more attention for acquired immune deficiency syndrome (AIDS) prevention and control in recent years in China. Few studies of HIV non-occupational post-exposure prophylaxis (nPEP) knowledge and service acceptance had been conducted among them in China. This study conducted a cross-sectional survey to understand the service acceptance of nPEP and its influencing factors among college students in the three cities of China. METHODS: A questionnaire survey was conducted to collect information on socio-demographic, behavioral characteristic, HIV/AIDS knowledge, nPEP knowledge, acceptance of nPEP services among the college students in Beijing, Shenzhen, and Kunming of China from March to April of 2019. Each participant completed an anonymous questionnaire on line by computer-assisted or mobile phone-assisted self-interview with informed consent. Multivariable logistic regression analyses identified predictors for service acceptance of nPEP. RESULTS: A total of 4698 students were surveyed with the average age of 20 years old. 98.0% (4605/4698) of them were undergraduates, 21.8%(1022/4698) had sexual intercourse; 48.6% (2282/4698) heard of nPEP, among which 4.95%(113/2282) received nPEP services. The awareness rate of HIV/AIDS knowledge was 85.6% (5495/4698) with the differences statistically significant between the three cities. The awareness rate of nPEP knowledge was 16.5% (774/4698). There were significant differences in receiving nPEP services among students of different ages, genders, sexual behaviors, and knowledge of HIV/AIDS by univariate analysis. Multivariable analyses indicated that age group of 18 and under (OR = 2.551, 95% CI = 1.153-5.646), male (OR = 3.131, 95% CI = 1.866-5.253), homosexual behavior (OR = 4.661,95%CI = 2.658-8.172), heterosexual behavior (OR = 1.676, 95% CI = 1.040-2.947), no awareness of AIDS knowledge (OR = 3.882, 95% CI = 2.371-6.356) and nPEP (OR = 4.788, 95% CI = 2.50-9.169) knowledge, were associated with the service acceptance of nPEP among the college students. CONCLUSION: The low acceptance of nPEP services was mainly affected by low level of nPEP knowledge among the college students. Further publicity and education of nPEP knowledge were necessary, as well as promotion of knowledge of HIV/AIDS prevention and treatment. More attention should be paid to the factors associated with acceptance of nPEP services.

Neuropsychiatric Adverse Events During 12 Months of Treatment With Efavirenz in Treatment-Naïve HIV-Infected Patients in China: A Prospective Cohort Study.

Background: Efavirenz (EFV) is widely used in antiretroviral therapy (ART), but the incidence and risk factors of neuropsychiatric adverse events (NPAEs) after EFV treatment have rarely been studied in Chinese ART naïve patients. Methods: This prospective cohort study assessed HIV-infected patients initiating antiretroviral treatment with EFV to determine prevalence of and factors associated with NPAEs over a 12-month follow-up period using the Hospital Anxiety and Depression Scale (HADS) and the Pittsburgh Sleep Quality Index (PSQI). Results: A total of 546 patients were enrolled. Prevalence of anxiety, depression, and sleep disturbances at baseline were 30.4, 22.7, and 68.1%, respectively. Six patients discontinued treatment due to drug related NPAEs. Treatment was associated with improvements in HADS-A, HADS-D, and PSQI scores over the 12-month follow-up, and the frequencies of patients with anxiety, depression, and sleep disturbances significantly decreased after 12 months. Abnormal baseline HADS-A, HADS-D, and PSQI scores and other factors, including high school education or lower income, unemployment, divorce, and WHO III/IV stages, were associated with severe neuropsychiatric disorders over the 12 months. Conclusions: These findings suggested EFV discontinuation due to NAPEs was low, and the HADS-A, HADS-D, and PSQI scores after 12 months of EFV treatment were associated with several risk factors. The clinicians should keep in mind and routinely screen for the risk factors associated with neuropsychiatric disorders in HIV-infected patients.

Effect of a multi-dimensional case management model on anti-retroviral therapy-related outcomes among people living with human immunodeficiency virus in Beijing, China.

BACKGROUND: This paper introduces a comprehensive case management model uniting doctors, nurses, and non-governmental organizations (NGOs) in order to shorten the time from HIV diagnosis to initiation of antiviral therapy, improve patients' adherence, and ameliorate antiretroviral treatment (ART)-related outcomes. METHODS: All newly diagnosed human immunodeficiency virus (HIV) cases at Beijing YouAn Hospital from January 2012 to December 2013 were selected as the control group, while all newly diagnosed HIV-infected patients from January 2015 to December 2016 were selected as the intervention group, receiving the comprehensive case management model. RESULTS: 4906 patients were enrolled, of which 1549 were in the control group and 3357 in the intervention group. The median time from confirming HIV infection to ART initiation in the intervention group was 35 (18-133) days, much shorter than the control group (56 (26-253) days, P < 0.001). Participants in the intervention group had better ART adherence compared to those in the control group (intervention: 95.3%; control: 89.2%; p < 0.001). During the 2 years' follow-up, those receiving case management were at decreased odds of experiencing virological failure (OR: 0.27, 95%CI: 0.17-0.42, P < 0.001). Observed mortality was 0.4 deaths per 100 patient-years of follow-up for patients in the control group compared with 0.2 deaths per 100 patient-years of follow-up in the intervention group. CONCLUSIONS: People living with HIV engaged in the comprehensive case management model were more likely to initiate ART sooner and maintained better treatment compliance and improved clinical outcomes compared to those who received routine care. A comprehensive case management program could be implemented in hospitals across China in order to reduce the HIV disease burden in the country.

Is PrEP necessary during natural conception in HIV-1-serodiscordant couples on ART with suppressed viral load? A retrospective cohort analysis.

BACKGROUND: Antiretroviral therapy (ART) demonstrates high efficacy in reducing the risk of HIV transmission to sexual partners. However, it is not clear if the use of pre-exposure prophylaxis (PrEP) in HIV-1-serodiscordant couples is necessary during natural conception when the HIV-positive partner exhibits a suppressed viral load. The purpose of this study was to assess the role of PrEP during natural conception in this population. METHODS: A retrospective, multicenter study was conducted in a cohort of HIV-1-serodiscordant couples (positive man, negative woman) with childbearing desires. HIV-positive male partners were treated with ART and achieved viral suppression for more than half a year. The HIV-negative female partners were either treated with PrEP or not treated with PrEP, and outcomes were compared between the two treatment groups. RESULTS: Of 246 HIV-1-serodiscordant couples in whom the HIV-positive partner achieved viral suppression, 104 seronegative women were treated with PrEP during natural conception and 142 seronegative women were not treated with PrEP. There were 410 condom-less sexual acts in couples treated with PrEP and 615 condom-less sexual acts in couples not treated with PrEP. We observed no instances of HIV transmission in HIV-1-serodiscordant couples with or without the use of PrEP during the process of natural conception. CONCLUSIONS: Our results show that PrEP had minimal influence in reducing the risk of HIV transmission during natural conception in HIV-1-serodiscordant couples with a stably suppressed viral load. Thus, it may be an acceptable option for HIV-negative partners to not use PrEP during the process of natural conception if the HIV-positive partner has achieved viral suppression for more than half a year.

Adverse events in Chinese human immunodeficiency virus (HIV) patients receiving first line antiretroviral therapy.

BACKGROUND: Although the global human immunodeficiency virus (HIV) epidemic has improved significantly due to antiretroviral treatment (ART), ART-related adverse events (AEs) remain an issue. Therefore, investigating the factors associated with ART-related AEs may provide vital information for monitoring risks. METHODS: A prospective cohort study was conducted among adult patients (aged 18 years or older) with HIV who received Tenofovir (TDF) + Lamivudine (3TC) + Efavirenz (EFV) as first-line ART regimens. All AEs during the first 12 months of therapy were recorded. Logistic regression analysis was used to identify variables associated with AEs. RESULTS: Four hundred seventy-four patients receiving TDF+ 3TC+ EFV ART regimens between March 2017 and October 2017 were included in the study analysis. Among them, 472 (99.6%) experienced at least one AE, 436 (92.0%) patients experienced at least one AE within 1 month of treatment, 33 (7.0%) between one and 3 months of treatment, and three (0.6%) patients after 3 months of treatment. The most commonly reported AE was nervous system (95.6%) related, followed by dyslipidemia (79.3%), and impaired liver function (48.1%). Patients with baseline body mass index (BMI) greater than 24 kg/m2 (adjusted OR 1.77, 95%CI 1.03-3.02), pre-existing multiple AEs (adjusted OR 2.72, 95%CI 1.59-4.64), and pre-existing severe AEs (adjusted OR 5.58, 95%CI 2.65-11.73) were at increased odds of developing a severe AE. Patients with baseline BMI greater than 24 kg/m2 (adjusted OR 2.72, 95%CI 1.25-5.89) were more likely to develop multiple AEs. CONCLUSION: The incidence of ART-related adverse events over a 12-month period in China was high. Baseline BMI greater than 24 kg/m2, pre-existing multiple AEs, and pre-existing severe AEs were shown to be independent risk factors for developing a severe AE.

Impact of Lopinavir/Ritonavir and Efavirenz-Based Antiretroviral Therapy on the Lipid Profile of Chinese HIV/AIDS Treatment-Naïve Patients in Beijing: A Retrospective Study.

BACKGROUND: Antiretroviral therapy (ART) is associated with lipid abnormalities that contribute to increased risk of cardiovascular (CV) events among patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Although disorders of lipid metabolism associated with ART have been described before in developed countries, data on lipid profile disorders associated with ART use in China are limited. This study aimed to examine the changes in lipid profile among patients with HIV/AIDS who initiated lopinavir/ritonavir LPV/r or efavirenz (EFV)-based antiretroviral treatment regimens, which continue to be widely used China and other developing countries. METHODS: This is a retrospective, matched case-control study of HIV-positive patients initiating either LPV/r or EFV regimens at the Beijing You'an Hospital, Capital Medical University between July 2012 and January 2017. Generalized estimating equations were used to compare the differences in total cholesterol [TC], triglycerides [TG], low-density lipoprotein-cholesterol [LDL-C], and highdensity lipoprotein-cholesterol [HDL-C] at baseline and up to 24-months after ART initiation between the two treatment arms. RESULTS: Baseline characteristics, including age, sex, CD4 cell count, viral load, and serum lipids, which were comparable between the two groups. The LPV/r-based regimen group had increased TC, TG, HDL-C, and LDL-C after 24-months of treatment. In the EFV-regimen group, TC, HDL-C, and LDL-C were increased compared to baseline, while the TC/HDL-C ratio decreased, and TG did not change significantly. After 24-months of treatment, the percentage of patients with dyslipidemia in the LPV/r group was much higher than in the EFV group (84.0% vs. 52.6%, P<0.001), and 17(10%) patients on LPV/r-based regimens had severe dyslipidemia. Patients on LPV/r-based regimens were at increased odds of hypercholesterolemia (odds ratio [OR]=1.709, P=0.038), hypertriglyceridemia (OR=4.315, P<0.001), and high TC/HDL-C ratio (OR=1.951, P=0.003). However, no significant difference was found in HDL-C (OR=1.246, P=0.186) or LDL-C (OR=1.253, P=0.410) between the treatment groups. CONCLUSION: Both LPV/r or EFV treatment regimens impacted patients' lipid profiles. Compared to EFV-based regimens, patients on LPV/r-based regimens had increased odds of dyslipidemia, such as hypercholesterolemia, hypertriglyceridemia, or high TC/HDL-C ratio; however, there was no obvious effect on LDL-C, which is more relevant to the development of the cardiovascular disease.

Natural Conception May Be an Acceptable Option in HIV-Serodiscordant Couples in Resource Limited Settings.

Many HIV serodiscordant couples have a strong desire to have their own biological children. Natural conception may be the only choice in some resource limited settings but data about natural conception is limited. Here, we reported our findings of natural conception in HIV serodiscordant couples. Between January 2008 and June 2014, we retrospectively collected data on 91 HIV serodiscordant couples presenting to Beijing Youan Hospital with childbearing desires. HIV counseling, effective ART on HIV infected partners, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) in negative female partners and timed intercourse were used to maximally reduce the risk of HIV transmission. Of the 91 HIV serodiscordant couples, 43 were positive in male partners and 48 were positive in female partners. There were 196 unprotected vaginal intercourses, 100 natural conception and 97 newborns. There were no cases of HIV seroconversion in uninfected sexual partners. Natural conception may be an acceptable option in HIV-serodiscordant couples in resource limited settings if HIV-positive individuals have undetectable viremia on HAART, combined with HIV counseling, PrEP, PEP and timed intercourse.