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1.
Molecules ; 27(1)2022 Jan 04.
Article in English | MEDLINE | ID: covidwho-1613911

ABSTRACT

When developing drugs against SARS-CoV-2, it is important to consider the characteristics of patients with different co-morbidities. People infected with HIV-1 are a particularly vulnerable group, as they may be at a higher risk than the general population of contracting COVID-19 with clinical complications. For such patients, drugs with a broad spectrum of antiviral activity are of paramount importance. Glycyrrhizinic acid (Glyc) and its derivatives are promising biologically active compounds for the development of such broad-spectrum antiviral agents. In this work, derivatives of Glyc obtained by acylation with nicotinic acid were investigated. The resulting preparation, Glycyvir, is a multi-component mixture containing mainly mono-, di-, tri- and tetranicotinates. The composition of Glycyvir was characterized by HPLC-MS/MS and its toxicity assessed in cell culture. Antiviral activity against three strains of SARS-CoV-2 was tested in vitro on Vero E6 cells by MTT assay. Glycyvir was shown to inhibit SARS-CoV-2 replication in vitro (IC502-8 µM) with an antiviral activity comparable to the control drug Remdesivir. In addition, Glycyvir exhibited marked inhibitory activity against HIV pseudoviruses of subtypes B, A6 and the recombinant form CRF63_02A (IC50 range 3.9-27.5 µM). The time-dependence of Glycyvir inhibitory activity on HIV pseudovirus infection of TZM-bl cells suggested that the compound interfered with virus entry into the target cell. Glycyvir is a promising candidate as an agent with low toxicity and a broad spectrum of antiviral action.


Subject(s)
Antiviral Agents/pharmacology , COVID-19/drug therapy , Glycyrrhizic Acid/chemistry , HIV Infections/drug therapy , HIV-1/drug effects , SARS-CoV-2/drug effects , Virus Replication , Animals , Antiviral Agents/chemical synthesis , COVID-19/virology , Chlorocebus aethiops , HIV Infections/virology , HeLa Cells , Humans , In Vitro Techniques , Vero Cells
2.
BMJ Open ; 12(1): e056009, 2022 01 03.
Article in English | MEDLINE | ID: covidwho-1608870

ABSTRACT

OBJECTIVES: This study aims to identify levels of adherence to antiretroviral therapy (ART) drugs and factors associated with them in Northwest Ethiopia. We hypothesise that in the era of COVID-19, there would be suboptimal adherence to ART drugs. DESIGN: An observational cross-sectional study was conducted. Factors associated with the level of adherence were selected for multiple logistic regressions at a p value of less than 0.2 in the analysis. Statistically significant associated factors were identified at a p value less than 0.05 and adjusted OR with a 95% CI. SETTING: The study was conducted in one specialised hospital and three district hospitals found in the South Gondar zone, Northwest Ethiopia. PARTICIPANTS: About 432 people living with HIV/AIDS receiving highly active ART in South Gondar zone public hospitals and who have been on treatment for more than a 3-month period participated in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: Levels of adherence to ART drugs and their associated factors. RESULTS: Among 432 study participants, 81.5% (95% CI: 78% to 85.2%) of participants were optimally adherent to ART drugs. Determinants of a low level of adherence: stigma or discrimination (OR=0.4, p=0.016), missed scheduled clinical visit (OR=0.45, p=0.034), being on tuberculosis treatment (OR=0.45, p=0.01), recent CD4 cell count less than 500 cells/mm3 (OR=0.3, p=0.023) and patients who had been on WHO clinical stage III at the time of ART initiation (OR=0.24, p=0.027) were factors significantly associated with adherence to ART drugs. CONCLUSIONS: Level of adherence was relatively low compared with some local studies. The intervention targeted to reduce discrimination, counselling before initiation of treatment and awareness regarding compliance is advised to improve adherence to antiretroviral regimens.


Subject(s)
COVID-19 , HIV Infections , Cross-Sectional Studies , Ethiopia , HIV Infections/drug therapy , Humans , Medication Adherence , SARS-CoV-2
4.
Glob Health Sci Pract ; 9(4): 978-989, 2021 12 31.
Article in English | MEDLINE | ID: covidwho-1594125

ABSTRACT

INTRODUCTION: Faced with the coronavirus disease (COVID-19) pandemic, governments worldwide instituted lockdowns to curtail virus spread. Health facility closures and travel restrictions disrupted access to antiretroviral (ARV) therapy for people living with HIV. This report describes how HIV programs in Indonesia, Laos, Nepal, and Nigeria supported treatment continuation by introducing home delivery of ARVs. METHODS: Staff supporting the programs provided accounts of when and how decisions were taken to support ARV home delivery. They captured programmatic information about home delivery implementation using an intervention documentation tool. The 4 country experiences revealed lessons learned about factors favoring successful expansion of ARV home delivery. RESULTS: Three of the countries relied on existing networks of community health workers for ARV delivery; the fourth country, Indonesia, relied on a private sector courier service. Across the 4 countries, between 19% and 51% of eligible clients were served by home delivery. The experiences showed that ARV home delivery is feasible and acceptable to health service providers, clients, and other stakeholders. Essential to success was rapid mobilization of stakeholders who led the design of the home delivery mechanisms and provided leadership support of the service innovations. Timely service adaptation was made possible by pre-existing differentiated models of care supportive of community-based ARV provision by outreach workers. Home delivery models prioritized protection of client confidentiality and prevention measures for COVID-19. Sustainability of the innovation depends on reinforcement of the commodity management infrastructure and investment in financing mechanisms. CONCLUSION: Home delivery of ARVs is a feasible client-centered approach to be included among the options for decentralized drug distribution. It serves as a measure for expanding access to care both when access to health services is disrupted and under routine circumstances.


Subject(s)
COVID-19 , HIV Infections , Pharmaceutical Preparations , Communicable Disease Control , HIV Infections/drug therapy , Humans , Indonesia , Laos , Nepal , Nigeria , SARS-CoV-2
5.
J Int AIDS Soc ; 24(12): e25846, 2021 12.
Article in English | MEDLINE | ID: covidwho-1591262

ABSTRACT

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.


Subject(s)
Acquired Immunodeficiency Syndrome , Biomedical Research , Coinfection , HIV Infections , Child , Female , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans , Pregnancy , Stakeholder Participation
6.
AIDS ; 36(2): 161-168, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1583938

ABSTRACT

The relative susceptibility of people with HIV (PWH) to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is debated. Numerous studies have been published with apparently contradictory findings, but comparisons are difficult because they have been conducted in populations with different characteristics (e.g. age, prevalence comorbidities) and have used different comparison groups (e.g. HIV-negative cohorts, coronavirus disease 2019 (COVID-19) hospitalized patients, general population), and because of challenges to measure the most important confounders. Here, we review the evidence regarding risk and severity of SARS-CoV-2 infection in PWH compared with persons without HIV. Publications originate largely from high-income settings where the majority of the PWH are on antiretroviral therapy (ART). Despite early evidence supporting higher frequency of SARS-CoV-2 testing in PWH on ART, HIV infection is not associated with SARS-CoV-2 infection, once confounding by socioeconomic characteristic is taken into account. Most publications identify increased COVID-19 severity in PWH compared with people without HIV from the general population or compared with COVID-19 hospitalized patients. The only study with an adequate comparison group to reduce confounding, has not identified differences in COVID-19 disease severity by HIV. Publications consistently identify that COVID-19 severity in PWH is not homogeneous and increases with age and baseline comorbidities. As PWH have a higher prevalence of comorbidities than people without HIV, examining their respective contribution to poor health outcomes is not straight forward as comorbidities could mediate the effect of HIV on COVID-19 outcomes.


Subject(s)
COVID-19 , HIV Infections , Anti-Retroviral Agents/therapeutic use , COVID-19 Testing , HIV Infections/complications , HIV Infections/drug therapy , Humans , SARS-CoV-2
7.
J Acquir Immune Defic Syndr ; 88(3): 299-304, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1574388

ABSTRACT

BACKGROUND: We assessed the impact of the coronavirus disease 2019 (COVID-19) pandemic on HIV suppression rates in people living with HIV (PLWH) attending a large Italian HIV clinic. SETTING: The HIV outpatient clinic of the Infectious Diseases Department of Luigi Sacco Hospital, Milan, Italy, which serves more than 5000 PLWH per year. METHODS: A before and after quasi-experimental study design was used to make a retrospective assessment of the monthly trend of HIV-RNA determinations of ≥50 among the PLWH attending our clinic, with "before" being the period from January 1, 2016 to February 20, 2020, and "after" being the period from February 21, 2020 to December 31, 2020 (the COVID-19 period). Interrupted time series analysis was used to evaluate any changes in the trend. RESULTS: During the study period, 70,349 HIV-RNA viral load determinations were made, and the percentage of HIV-RNA viral load determinations of <50 copies/mL increased from 88.4% in 2016 to 93.2% in 2020 (P < 0.0001). There was a significant monthly trend toward a decrease in the number of HIV-RNA determinations of ≥50 copies/mL before the pandemic (ß -0.084; standard error 0.015; P < 0.001), and this did not significantly change after it started (ß -0.039, standard error 0.161; P = 0.811). CONCLUSIONS: A high prevalence of viral suppression was maintained among the PLWH referring to our clinic, despite the structural barriers raised by the COVID-19 pandemic. The use of simplified methods of delivering care (such as teleconsultations and multiple antiretroviral treatment prescriptions) may have contributed to preserving this continuum.


Subject(s)
Anti-HIV Agents/therapeutic use , COVID-19/complications , COVID-19/epidemiology , HIV Infections/complications , HIV Infections/epidemiology , Ambulatory Care Facilities , Anti-HIV Agents/administration & dosage , Delivery of Health Care/methods , HIV Infections/drug therapy , HIV-1 , Humans , Italy/epidemiology , RNA, Viral/blood , SARS-CoV-2 , Viral Load/drug effects
8.
J Acquir Immune Defic Syndr ; 89(1): 1-8, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1561815

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) symptoms among people living with HIV (PLWH) are not well described. SETTING: Longitudinal survey within the MACS/WIHS Combined Cohort Study (MWCCS) of PLWH compared with similar HIV-seronegative (SN) individuals. METHODS: Telephone-administered survey of MWCCS participants at 13 clinical research sites across the United States addressing COVID-19 symptoms, SARS-CoV-2 testing, and pandemic impact on social distancing and antiretroviral therapy (ART) use. Primary data collection occurred during May (wave 1), June-July (wave 2), and August-September, 2020 (wave 3). RESULTS: One-third of MWCCS participants were tested for SARS-CoV-2 infection; 10% was tested ≥2 times. Similar proportions of PLWH and SN participants were tested, but SARS-CoV-2 positivity was higher among PLWH than among SN individuals (9.4% vs 4.8%, P = 0.003). Odds of SARS-CoV-2 positivity remained higher among PLWH after adjusting for age, sex, race/ethnicity, and study site (adjusted odds ratio = 2.0, 95% confidence interval = 1.2 to 3.2). SARS-CoV-2 positivity was not associated with CD4 cell counts among PLWH. Among SARS-CoV-2 positive participants, 9% had no symptoms, 7% had 1-2 mild symptoms, and 84% had ≥3 symptoms. Most of the (98%) participants reported physical distancing during all survey waves; self-reported ART adherence among PLWH was not adversely affected during the pandemic compared with the previous year (similar adherence in 89% of participants, improved in 9% of participants, and decreased in 2% of participants). CONCLUSIONS: Despite similar SARS-CoV-2 testing and physical distancing profiles by HIV serostatus among MWCCS participants, PLWH who reported SARS-CoV-2 testing were more likely to have a positive test result. Additional studies are needed to determine whether and why PLWH are at increased risk of SARS-CoV-2 infection.


Subject(s)
COVID-19/diagnosis , Fever/etiology , HIV Infections/complications , Pharyngitis/etiology , SARS-CoV-2/isolation & purification , Aged , CD4 Lymphocyte Count , COVID-19/epidemiology , COVID-19 Testing , Cohort Studies , Cough , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Longitudinal Studies , Male , Middle Aged , Prevalence
9.
Lancet HIV ; 8(11): e661-e662, 2021 11.
Article in English | MEDLINE | ID: covidwho-1541052
10.
Lancet HIV ; 8(11): e701-e710, 2021 11.
Article in English | MEDLINE | ID: covidwho-1541051

ABSTRACT

BACKGROUND: Factors affecting outcomes of SARS-CoV-2 infection in people living with HIV are unclear. We assessed the factors associated with SARS-CoV-2 diagnosis and severe outcomes among people living with HIV. METHODS: We did a retrospective cohort study using data from the PISCIS cohort of people with HIV in Catalonia (Spain) between March 1 and Dec 15, 2020. We linked PISCIS data with integrated health-care, clinical, and surveillance registries through the Public Data Analysis for Health Research and Innovation Program of Catalonia (PADRIS) to obtain data on SARS-CoV-2 diagnosis, chronic comorbidities, as well as clinical and mortality outcomes. Participants were aged at least 16 years in care at 16 hospitals in Catalonia. Factors associated with SARS-CoV-2 diagnoses and severe outcomes were assessed using univariable and multivariable Cox regression models. We estimated the effect of immunosuppression on severe outcomes (hospital admission for >24 h with dyspnoea, tachypnoea, hypoxaemia, asphyxia, or hyperventilation; or death) using Kaplan-Meier survival analysis. FINDINGS: We linked 20 847 (72·8%) of 28 666 participants in the PISCIS cohort with PADRIS data; 13 142 people had HIV. 749 (5·7%) people with HIV were diagnosed with SARS-CoV-2: their median age was 43·5 years (IQR 37·0-52·7), 131 (17·5%) were female, and 618 (82·5%) were male. 103 people with HIV (13·8%) were hospitalised, seven (0·9%) admitted to intensive care, and 13 (1·7%) died. SARS-CoV-2 diagnosis was more common among migrants (adjusted hazard ratio 1·55, 95% CI 1·31-1·83), men who have sex with men (1·42, 1·09-1·86), and those with four or more chronic comorbidities (1·46, 1·09-1·97). Age at least 75 years (5·2, 1·8-15·3), non-Spanish origin (2·1, 1·3-3·4), and neuropsychiatric (1·69, 1·07-2·69), autoimmune disease (1·92, 1·14-3·23), respiratory disease (1·84, 1·09-3·09), and metabolic disease (2·59, 1·59-4·23) chronic comorbidities were associated with increased risk of severe outcomes. A Kaplan-Meier estimator showed differences in the risk of severe outcomes according to CD4 cell count in patients with detectable HIV RNA (p=0·039) but no differences were observed in patients with undetectable HIV RNA (p=0·15). INTERPRETATION: People living with HIV with detectable HIV viraemia, chronic comorbidities, and some subpopulations could be at increased risk of severe outcomes from COVID-19. These groups should be prioritised in clinical management and SARS-CoV-2 vaccination programmes. FUNDING: Fundació "la Caixa". TRANSLATIONS: For the Catalan, Spanish and Russian translations of the Summary see Supplementary Materials section.


Subject(s)
COVID-19/immunology , COVID-19/mortality , HIV Infections/complications , HIV Infections/immunology , Immunoglobulin G/blood , SARS-CoV-2/immunology , Adult , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/epidemiology , COVID-19 Testing , COVID-19 Vaccines , Cohort Studies , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Immunologic Factors , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , Socioeconomic Factors , Spain/epidemiology
12.
Ann Intern Med ; 174(9): 1311-1312, 2021 09.
Article in English | MEDLINE | ID: covidwho-1527000
14.
AIDS Res Ther ; 18(1): 87, 2021 11 19.
Article in English | MEDLINE | ID: covidwho-1526645

ABSTRACT

BACKGROUND: Events associated with the COVID-19 pandemic, such as physical distancing, closure of community services, postponement of health appointments, and loss of employment can lead to social isolation, financial uncertainty, and interruption of antiretroviral adherence, resulting in additional health-related challenges (disability) experienced among adults living with chronic illness such as HIV. 'Living strategies' is a concept derived from the perspectives of people living with HIV, defined as behaviors, attitudes and beliefs adopted by people living with HIV to help deal with disability associated with HIV and multi-morbidity. Our aim was to describe disability among adults living with HIV and self-care living strategies used during the COVID-19 pandemic. METHODS: Adults living with HIV in Toronto, Ontario, Canada, including some with pre-pandemic HIV Disability Questionnaire (HDQ) data, completed a cross-sectional web-based survey between June-August 2020. The survey included the HDQ and questions about self-care living strategy use during the pandemic. We compared disability (HDQ) scores prior to versus during the pandemic using paired t-tests. We reported the proportion of participants who engaged in various living strategies at least 'a few times a week' or 'everyday' during the pandemic. RESULTS: Of the 63 respondents, 84% were men, median age 57 years, and 62% lived alone. During the pandemic the greatest disability severity was in the uncertainty [median 30; Interquartile range (IQR): 16, 43] and mental-emotional (25; IQR: 14, 41) domains. Among the 51 participants with pre-pandemic data, HDQ severity scores were significantly greater (worse) during the pandemic (vs prior) in all domains. Greatest change from prior to during the pandemic was in the mental-emotional domain for presence (17.7; p < 0.001), severity (11.4; p < 0.001), and episodic nature (9.3; p < 0.05) of disability. Most participants (> 60%) reported engaging a 'few times a week' or 'everyday' in self-care strategies associated with maintaining sense of control and adopting positive attitudes and beliefs. CONCLUSIONS: People living with HIV reported high levels of uncertainty and mental-emotional health challenges during the pandemic. Disability increased across all HDQ dimensions, with the greatest worsening in the mental-emotional health domain. Results provide an understanding of disability and self-care strategy use during the COVID-19 pandemic.


Subject(s)
COVID-19 , HIV Infections , Adult , Cross-Sectional Studies , Disability Evaluation , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2 , Self Care , Surveys and Questionnaires
15.
Lancet ; 397(10279): 1127-1138, 2021 03 20.
Article in English | MEDLINE | ID: covidwho-1525996

ABSTRACT

In 2010, the US health insurance system underwent one of its most substantial transformations with the passage of the Affordable Care Act, which increased coverage for millions of people in the USA, including those with and at risk of HIV. Even so, the system of HIV care and prevention services in the USA is a complex patchwork of payers, providers, and financing mechanisms. People with HIV are primarily covered by Medicaid, Medicare, private insurance, or a combination of these; many get care through other programmes, particularly the Ryan White HIV/AIDS Program, which serves as the nation's safety net for people with HIV who remain uninsured or underinsured but offers modest to no support for prevention services. While uninsurance has drastically declined over the past decade, the USA trails other high-income countries in key HIV-specific metrics, including rates of viral suppression. In this paper in the Series, we provide an overview of the coverage and financing landscape for HIV treatment and prevention in the USA, discuss how the Affordable Care Act has changed the domestic health-care system, examine the major programmes that provide coverage and services, and identify remaining challenges.


Subject(s)
Acquired Immunodeficiency Syndrome/epidemiology , COVID-19/economics , HIV Infections/drug therapy , HIV Infections/prevention & control , Insurance Coverage/legislation & jurisprudence , Insurance, Health/legislation & jurisprudence , Acquired Immunodeficiency Syndrome/drug therapy , Adult , Aged , Anti-Retroviral Agents/therapeutic use , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , Female , Gender Identity , HIV Infections/economics , HIV Infections/epidemiology , Humans , Incidence , Male , Medicaid/statistics & numerical data , Medically Uninsured/statistics & numerical data , Medicare/statistics & numerical data , Middle Aged , Patient Protection and Affordable Care Act , Risk Assessment , SARS-CoV-2/genetics , United States/epidemiology
16.
J Int AIDS Soc ; 24 Suppl 7: e25829, 2021 11.
Article in English | MEDLINE | ID: covidwho-1525467

ABSTRACT

INTRODUCTION: The last 12 years have seen remarkable progress in the isolation and characterization of at least five different epitope classes of HIV-specific broadly neutralizing antibodies (bnAbs). Detailed analyses of these bnAb lineages, maturation pathways and epitopes have created new opportunities for vaccine development. In addition, interest exists in passive administration of monoclonal antibodies as a viable option for HIV prevention. DISCUSSION: Recently, two antibody-mediated prevention (AMP) trials of a passively administered monoclonal antibody targeting the HIV envelope CD4 binding site, called VRC01, provided proof-of-concept that monoclonal antibody infusion could offer protection against HIV acquisition. While the trials failed to show overall protection against HIV acquisition, sub-analyses revealed that VRC01 infusion provided a 75% prevention efficacy against HIV strains that were susceptible to the antibody. The study also demonstrated that in vitro neutralizing activity, measured by the TZM-bl/pseudovirus assay, was able to predict HIV prevention efficacy in humans. In addition, the AMP trials defined a threshold protective concentration, or neutralization titer, for the VRC01 class of bnAbs, explaining the observed low overall efficacy and serving as a benchmark for the clinical testing of new bnAbs, bnAb cocktails and neutralizing antibody-inducing vaccines. Newer bnAbs that exhibit greater potency and breadth of neutralization in vitro than VRC01 are available for clinical testing. Combinations of best-in-class bnAbs with complementary magnitude, breadth and extent of complete neutralization are predicted to far exceed the prevention efficacy of VRC01. Some engineered bi- and trispecific mAbs exhibit similar desirable neutralizing activity and afford advantages for manufacturing and delivery. Modifications that prolong the serum half-life and improve genital tissue persistence offer additional advantages. CONCLUSIONS: Iterative phase 1 trials are acquiring safety and pharmacokinetic data on dual and triple bnAbs and bi- and trispecific antibodies in preparation for future AMP studies that seek to translate findings from the VRC01 efficacy trials and achieve acceptable levels of overall prevention efficacy.


Subject(s)
HIV Infections , HIV-1 , Antibodies, Monoclonal/therapeutic use , Broadly Neutralizing Antibodies , HIV Antibodies , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans
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