Human Immunodeficiency Virus Medications Research Articles

HIV-TB Coinfection: Current Therapeutic Approaches and Drug Interactions.

The co-occurrence of human immunodeficiency virus (HIV) and tuberculosis (TB) infection poses a significant global health challenge. Treatment of HIV and TB co-infection often necessitates combination therapy involving antiretroviral therapy (ART) for HIV and anti-TB medications, which introduces the potential for drug-drug interactions (DDIs). These interactions can significantly impact treatment outcomes, the efficacy of treatment, safety, and overall patient well-being. This review aims to provide a comprehensive analysis of the DDIs between anti-HIV and anti-TB drugs as well as potential adverse effects resulting from the concomitant use of these medications. Furthermore, such findings may be used to develop personalized therapeutic strategies, dose adjustments, or alternative drug choices to minimize the risk of adverse outcomes and ensure the effective management of HIV and TB co-infection.

Evaluating elimination of mother-to-child transmission of HIV in Suriname: a mixed method study.

To evaluate the cascade of care for the elimination of mother-to-child-transmission of human immunodeficiency virus (HIV) in Suriname and identify sociodemographic and clinical factors preventing transmission to exposed infants. A mixed-methods study design was used. Antenatal care data from the 2018 cross-sectional multi-indicator cluster survey on 1 026 women aged 15-49 years who had had a live birth in the previous 2 years were used. Furthermore, national data on a cohort of 279 mothers with HIV and their 317 infants born from 2016 to 2018 were evaluated. Additionally, 13 cases of mother-to-child-transmission of HIV were reviewed. In 89.3% of cases, no mother-to-child HIV transmission occurred. Early cascade steps show that 28.4% of women had unmet family planning needs, 15% had no antenatal visits, 8% delivered outside a health facility, and 71.5% received an HIV test during antenatal care. Of the pregnant women with HIV, 84.2% received antiretroviral therapy, while 95.5% of their infants received HIV prophylactic treatment. Receiving antiretroviral therapy for the mother (odds ratio (OR) 45.4, 95% confidence interval (CI) 9.6-215.3) and the child (OR 145.7, 95% CI 14.4-1477.4) significantly increased the odds of a negative HIV test result in infants. Conversely, living in the interior decreased the odds (OR 0.2, 95% CI 0.4-0.7) compared with urban living. HIV medication for mothers with HIV and their infants remains key in the prevention of mother-to-child-transmission of HIV. Early prenatal care with follow-up should be strengthened in Suriname.

Acute HIV Diagnosis After Initiation of Pre-exposure Prophylaxis in a Young Adult Patient: A Case Report

Oral pre-exposure prophylaxis (PrEP) in the prevention of human immunodeficiency virus (HIV) infection is highly effective, yet the majority of sexually active adolescents and young adults (AYAs) at highest risk for HIV infection, particularly AYA males who have sex with males, have not been prescribed this medication. Provider hesitancy in prescribing PrEP to at-risk AYA patients is often associated with concerns about patient nonadherence and its effect on inducing HIV medication resistance. This case report has two aims. First, to outline the clinical course for an AYA patient prescribed PrEP for 3 months and then found to have HIV with an M184V resistance mutation and subsequently started on HIV treatment. And second, to illustrate how the benefits of PrEP initiation outweigh its risks by presenting clinical data on resistance patterns to PrEP medications. The patient eventually achieved viral suppression within 5 months of starting HIV treatment which has been sustained up to 2 years. This case illustrates that M184V resistance mutations, although rarely associated with PrEP, are unlikely to impact options for HIV treatment. Providers should recommend and prescribe oral PrEP to AYA patients at risk for HIV infection without concern for nonadherence leading to HIV medication resistance.

Examining Cash Expenditures and Associated HIV-Related Behaviors Using Financial Diaries in Women Employed by Sex Work in Rural Uganda: Findings from the Kyaterekera Study.

Women employed by sex work (WESW) have a high risk of human immunodeficiency virus (HIV) infection and experience economic barriers in accessing care. However, few studies have described their financial lives and the relationship between expenditures and HIV-related behaviors. This exploratory study used financial diaries to collect expenditure and income data from WESW in Uganda over 6 months. Data were collected as part of a larger trial that tested the efficacy of an HIV prevention intervention method. Descriptive statistics were used to quantify women's income, relative expenditures, and negative cash balances. Bivariate and multivariate logistic regressions were used to examine the odds of sexual risk behavior or use of HIV medications for several cash scenarios. A total of 163 WESW were enrolled; the participants mean age was 32 years old. Sex work was the sole source of employment for most WESW (99%); their average monthly income was $62.32. Food accounted for the highest proportion of spending (44%) followed by sex work (20%) and housing expenditures (11%). WESW spent the least on health care (5%). Expenditures accounted for a large but variable proportion of these women's income (56% to 101%). Most WESW (74%) experienced a negative cash balance. Some also reported high sex work (28%), health care (24%), and education (28%) costs. The prevalence of condomless sex (77%) and sex with drugs/alcohol (70%) was high compared to use of ART/PrEP (Antiretroviral therapy/Pre-exposure prophylaxis) medications (45%). Women's cash expenditures were not statistically significantly associated with HIV-related behaviors. However, the exploratory study observed a consistent null trend of lower odds of condomless sex (adjusted odds ratio (AOR) = 0.70, 95% confidence interval (CI): 0.28-1.70), sex with drugs/alcohol (AOR = 0.93, 95% CI: 0.42-2.05), and use of ART/PrEP (AOR = 0.80, 95% CI: 0.39-1.67) among women who experienced a negative cash balance versus those who did not. Similar trends were observed for other cash scenarios. Financial diaries are a feasible tool to assess the economic lives of vulnerable women. Despite having paid work, most WESW encountered a myriad of financial challenges with limited spending on HIV prevention. Financial protections and additional income-generating activities may improve their status. More robust research is needed to understand the potentially complex relationship between income, expenditures, and HIV risk among vulnerable sex workers.

Exploring Current Practice, Knowledge, and Challenges of Sexually Transmitted Infection/HIV Management and Pre-Exposure Prophylaxis Among Japanese Health Care Professionals: A Cross-Sectional Web Survey.

We conducted a web-based survey targeting physicians in specialties of treating sexually transmitted infection (STI) and/or human immunodeficiency virus (HIV) patients to understand the current STI/HIV care practices and their acceptability of and barriers to the prescription of pre-exposure prophylaxis (PrEP) in Japan. A descriptive analysis was used to summarize survey responses. Univariate and multivariable logistic regression were performed to identify factors associated with willingness to prescribe PrEP. Of 316 survey respondents, 57 were specialized in HIV, 90 STI/Urology/Proctology, 55 Obstetrics/Gynecology, and 114 General Practice/Internal Medicine/Dermatology. Proportion of HIV-specialized physicians who interview the patients about risk behaviors tended to be higher than other physician groups (84.2% vs. 54.8%, 47.3%, and 50.9%, respectively), and 53 - 75% of non-HIV-specialized physicians reported that they were incapable of making decisions on HIV medications. Higher PrEP knowledge enhanced the willingness to recommend and prescribe PrEP drugs (odds ratio: 2.31, 95% confidence interval: 1.30-4.10, p = 0.0044), and 45.4% physicians with no PrEP knowledge raised the concern of incapability to respond and manage when an individual is infected with HIV. Educational opportunities on management and prevention measures for both STI and HIV may encourage non-HIV-specialized physicians to be involved in HIV care and to enhance initiation of HIV tests and adoption of PrEP.

Fake drugs, real concerns: Counterfeit HIV medications and community trust.

Counterfeit medications infiltrate drug supply chains at various entry points. While scientific advancements continue to deter counterfeit medications, these imitation therapies still manage to circumvent national and international regulations to reach unsuspecting consumers. Certain manufacturers of human immunodeficiency virus (HIV) prevention and treatment medications within the United States recently encountered counterfeit versions of their therapies that in some instances contained antipsychotic and pain reliever products. People on HIV treatment or those taking HIV prevention therapies who consume counterfeit medications are at risk of having their HIV management strategies compromised or seroconverting from an HIV negative to an HIV positive status, respectively. The implicated manufacturers reportedly took legal actions against the discovered counterfeiters, alerted impacted pharmacies, and assisted them with removal of illegitimate drugs. However, communities' gradual awareness or lack thereof in regards to counterfeit HIV prevention and treatment medications is likely to result in speculation about how many consumers took real versus fake medications, contributing to consumer distrust. This commentary provides details of a stakeholder meeting that took place with one of the leading manufacturers of HIV treatment and prevention medications to query its responses to counterfeit medications identified among its available product supplies in pharmacies. This manuscript also recommends to manufacturers ways to augment their communication strategies to communities if similar medicinal breaches occurred in the future.

395 Hindering Generic Antiretroviral Treatment Competition for Human Immunodeficiency Virus: Anti-Competitive Agreements and HIV Disease Management Concerns

OBJECTIVES/GOALS: To understand the implications of minimal HIV generic drug availability on long-term HIV disease management, including anti-competitive agreements and patent strategies that hinder (ART) competition and ART medication safety and efficacy improvement. METHODS/STUDY POPULATION: Individuals living with Human Immunodeficiency Virus (HIV) require sustained ART treatment. Despite excessive ART costs, the treatments use active ingredients known to be toxic, causing bone and renal impairments. A review of pharmaceutical legal cases examined the role of strategic patenting–product hopping–and anti-competitive agreements, which prevent generic competition and contribute to minimal ART improvement. A literature review explored the long-term safety effects of ART medications on HIV patients and disease management. A cost analysis of HIV disease management assessed the implications of using treatments with known toxins and their contribution to comorbidities and their effect on the cost of overall HIV disease management. RESULTS/ANTICIPATED RESULTS: Ongoing lawsuits of major ART medication manufacturers demonstrate the intentional agreements made to hinder generic competition, which is an inherently anti-competitive strategy. Thus, prices for ART medications remained high, causing treatment costs to be a significant barrier to treatment access. Further, the entry of a new ART, Tenofovir Alafenamide Fumarate (TAF), was delayed despite knowing the key active ingredient in Tenofovir Disoproxil Fumarate (TDF) was toxic to patients long-term. As a result, patients were more likely to experience comorbidities, significantly increasing the cost of HIV care. The average cost of HIV care without comorbidities is $30,312. However, HIV care is $46,000 for two comorbidities and about $219,000 for people with 11 or more. DISCUSSION/SIGNIFICANCE: Abuse of patent rights prevents more effective HIV medication and generic option development. Thus, HIV disease management is inhibited. The only method of HIV disease management is patient adherence to ARTs. Patients taking less effective medications increase the development of comorbidities from toxic treatments, magnifying the cost of HIV care.

Student perceptions of PrEP in an advanced HIV elective

Background: The United States (U.S.) Centres for Disease Control and Prevention estimated that over one million U.S. adults could benefit from human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), but only 90,000 PrEP prescriptions are being filled annually. Pharmacists are well-positioned to offer PrEP, but a lack of awareness and knowledge about HIV PrEP has been a limitation. This study was designed to evaluate the knowledge, confidence, and perceptions of pharmacy students towards the use of HIV PrEP in high-risk populations before and after receiving a PrEP and PEP module in a two-credit hour Advanced HIV Elective course. Methods: Faculty in an Advanced HIV Elective course implemented a PrEP module and evaluated the impact on pharmacy student knowledge, confidence, and attitudes in 2020. Results: Participation led to a significant increase in student pharmacist confidence in offering patient education regarding the use of PrEP, risk mitigation counselling, accurately ordering labs, monitoring patients taking PrEP, and HIV medication therapy management. Additionally, HIV education shows decreased stigma and negative attitudes towards high-risk individuals. Conclusion: Integration of a PrEP module increased student pharmacist knowledge and confidence in providing PrEP services while reducing stigma towards those with HIV.

'They can stigmatize you': a qualitative assessment of the influence of school factors on engagement in care and medication adherence among adolescents with HIV in Western Kenya.

School-related factors may influence retention in care and adherence to antiretroviral therapy (ART) among adolescents with human immunodeficiency virus (HIV). We analyzed data from in-depth interviews with 40 adolescents with HIV (aged 14 -19 years), 40 caregivers of adolescents with HIV, and 4 focus group discussions with healthcare workers to evaluate contextual factors affecting adherence to ART and clinic attendance among adolescents, with a focus on the school environment. Informed by Anderson's Model of Health Services Utilization, transcripts were systematically coded and synthesized to identify school-related themes. All groups identified the school environment as a critical barrier to engagement in HIV care and medication adherence for adolescents with HIV. Adolescent participants reported inflexible school schedules and disclosure to school staff as the biggest challenges adhering to clinic appointments and ART. Adolescents described experiencing stigma and discrimination by peers and school staff and would adjust when, where and how often they took ART to avoid inadvertent disclosure. Boarding school students faced challenges because they had limited private space or time. Caregivers were often instrumental in navigating school permissions, including identifying a treatment supporter among school staff. Additional research engaging school staff may guide interventions for schools to reduce stigma and improve adherence and retention.

Effect of alcohol exposure on the efficacy and safety of tenofovir alafenamide fumarate, a major medicine against human immunodeficiency virus

Human immunodeficiency virus (HIV) continues to be a major health concern. AIDS-related deaths (acquired immunodeficiency syndrome) have decreased recently, but chronic liver disease is now a major cause of mortality among HIV patients. Widespread alcohol use is recognized to be a major contributing factor. Tenofovir alafenamide fumarate (TAF), one of the most used HIV drugs, requires hydrolysis followed by phosphorylation to produce tenofovir diphosphate, the ultimate anti-HIV metabolite. Carboxylesterase-1 (CES1), established to hydrolyze TAF, is known to catalyze transesterification in the presence of ethanol. The aim of the study was to test the hypothesis that metabolism-based interactions between TAF and ethanol negatively impact both efficacy and safety of TAF. To test this hypothesis, the metabolism of TAF was determined in human primary hepatocytes and with a large number of human liver samples (S9 fractions) in the presence or absence of ethanol. The metabolism was monitored by LC-MS/MS (liquid chromatography with tandem mass spectrometry) and the level of CES1 or CES2 was determined by Western blotting. Consistent with the hypothesis, TAF underwent transesterification in the presence of ethanol accompanied by decreased hydrolysis. The formation of tenofovir diphosphate (the therapeutically active metabolite) was significantly decreased. In addition, TAF but not its hydrolytic metabolite, was found to increase intracellular lipid retention, and the increase was enhanced by ethanol. These findings conclude that alcohol consumption, beyond commonly accepted poor adherence to HIV medications, directly impacts the efficacy and safety of TAF.

376 The Role of Antiretroviral Treatment Patenting on Consumer Pricing: Declining Viral Suppression and Treatment Non-Adherence Among HIV Patients in Los Angeles County

OBJECTIVES/GOALS: Antiretroviral treatments (ART) suppress retroviruses, like the human immunodeficiency virus (HIV). The goal is to understand how antiretroviral drug patents contribute to overpriced HIV medications, thereby causing cost-related treatment non-adherence and inhibiting viral suppression. METHODS/STUDY POPULATION: Currently, HIV affects 57,700 individuals in Los Angeles County (LAC). Data was compiled from Centers for Disease Control and Prevention (CDC), hiv.gov, lacounty.HIV, publichealth.lacounty.gov, and the U.S. Patent and Trade Office. A review of existing literature examined the role of ART patents on cost-related non-adherence and declining viral suppression on individuals living with HIV in LAC. Lastly, a comparison of HIV medication prices of expired and non-expired patents was conducted, indicating the effects of undue extensions of market exclusivity on ART regimen pricing, and how this affects treatment adherence. RESULTS/ANTICIPATED RESULTS: Of the ten ARTs examined, four had expired patents and six had active patents. Those with active patents cost more than those with inactive patents because active patent status prevents price reductions. Patent strategies–pay-for-delay settlements and patent evergreening–unduly extend market exclusivity, keeping ART at prohibitive costs and preventing generic competition. Individuals facing cost-related non-adherence were less virally suppressed at their last viral load test (64%) and at all tests during the year (54%). Thus, over-patented ARTs increase treatment prices, causing cost-related non-adherence to ART regimens. The implications include disease progression and less viral suppression. DISCUSSION/SIGNIFICANCE: The U.S. has the highest ART prices, yet the lowest rate of HIV viral suppression (54%) among all well-resourced countries. Undue extensions of market exclusivity cause ARTs to remain at prohibitive costs, preventing some patients from affording ART treatments, minimizing their viral suppression.

Hearing Loss, Congenital HIV, and Medulloblastoma: A Case Report

Hearing Loss, Congenital HIV, and Medulloblastoma: A Case Report

Relationship of sleep disorders with long-term complications and health-related quality of life in people with well-controlled human immunodeficiency virus.

Although sleep disorders are common in patients with human immunodeficiency virus (HIV) infection, they have not been adequately evaluated under currently advanced treatments, mainly with integrase strand transfer inhibitors. However, the relationship of sleep disorders with long-term complications and quality of life (QOL) status in patients infected with HIV is still poorly understood. Such associations are important in the management of outpatients with HIV. Hence, this study aimed to evaluate these associations.This cross-sectional observational study assessed the QOL changes of patients with HIV before and after the treatment regimen change. Male patients with well-controlled HIV who attended our hospital and changed HIV medications for reasons other than treatment failure between October 2019 and September 2021 were included. At the time of regimen change, sleep disorder status was assessed according to the Pittsburgh sleep quality index (PSQI), and health-related QOL (HRQOL) was assessed using the medical outcomes study 8-item short form health survey. In addition, we collected information on age, blood tests, and long-term comorbid conditions present during the evaluation. The HIV treatment regimen was also reviewed.Out of 45 male Japanese patients with HIV that were included in this study, 24 (53.3%) and 21 (46.7%) were classified into the sleep disorder group and nonsleep disorder group, respectively, according to their PSQI scores. The sleep disorder group had a significantly lower HRQOL mental component summary (P = .0222) than the nonsleep disorder group. The prevalence rates of hypertension, dyslipidemia, and diabetes mellitus were not significantly different between the 2 groups. In addition, a significant correlation was observed between PSQI scores and the HRQOL status (mental component summary, P = .0450; physical component summary, P = .0350).Sleep disorders remain common in patients with well-controlled HIV infection receiving current treatment. Sleep disorder is significantly associated with a low HRQOL in these patients. Hence, sleep status evaluation is necessary to improve HIV management.

Preexposure Prophylaxis Acceptability Among Pregnant Individuals and Implications for Human Immunodeficiency Virus Prevention.

To understand perspectives on and preferences for preexposure prophylaxis (PrEP) for pregnant individuals who are at risk for human immunodeficiency virus (HIV) infection. In this qualitative study, we purposively sampled and conducted in-depth interviews with pregnant participants at risk of HIV infection (indicated by a recent sexually transmitted infection [STI]) from a U.S. urban obstetrics clinic. Interview questions focused on perceived HIV risk, knowledge and perceptions of PrEP, and preferences for different PrEP formulations. We coded data using deductive and inductive codes, created matrices to explore patterns in findings, and wrote memos to interpret emergent themes. Twenty patients were enrolled. Median age of the participants was 24 years (interquartile range 19-26 years), 95.0% were African American, 65.0% were high school graduates, and 70.0% had unplanned pregnancies. Participants had low knowledge of PrEP and most saw themselves at low to no risk of HIV acquisition, despite their recent STI. Further, participants' low HIV risk perception and medication safety concerns reduced PrEP acceptability. Moreover, very few had discussed PrEP with their obstetrician-gynecologists (ob-gyns) during antenatal care, which further affected perceived acceptability. However, participants who did discuss PrEP with their ob-gyns had favorable perceptions of it. These participants indicated that they would choose a formulation based on individual preferences, which were largely shaped by perceived ease of use, acceptability, and prior experience with other medication regimens. Obstetrician-gynecologists may play an important role in increasing pregnant individuals' knowledge of and access to PrEP during pregnancy among those who are at risk of HIV acquisition. To maximize uptake and adherence during this time, PrEP formulations should be tailored to individual preferences. Prevention of HIV during this critical life transition is important not only for the long-term health and well-being of pregnant individuals and their infants, but to the plan to end the HIV epidemic in the United States by 2030.

Individual and Community Level Factors Related to HIV Diagnosis, Treatment, and Stigma in Kumasi, Ghana: A Field Report

The human immunodeficiency virus (HIV) is a public health issue globally and in Ghana. While efforts are underway to reduce HIV prevalence in Ghana, there are still some HIV-related issues (duration lived with HIV, mode of HIV diagnosis, HIV status disclosure, HIV treatment, HIV knowledge, and HIV prevention and stigma) that need to be addressed. The purpose of the field study was to examine individual and community level factors related to HIV diagnosis, treatment, and stigma in Kumasi, Ghana. Specifically, we conducted a field-based comparison of HIV-related issues in Kumasi and the US to determine areas of similarities and differences. Since our focus was the Kumasi district in general, and the Suntreso Government Hospital in particular, we used convenient sampling. Thus, study results are not generalizable to the entire population of Ghana. Given the short duration of the entire field study (three weeks) and the fact that most information on the HIV-related issues focused in Ghana are available in the US, secondary data from various sources were used for the US comparison. Results from the study showed that 29.2% of participants in Kumasi had lived with HIV for seven or more years, while data from the US showed that people generally live with HIV for 20 years or more after testing positive for the disease. Most of the study participants in Kumasi (68.5%) stated that they were diagnosed with HIV through a laboratory blood sample test, while rapid antibody and ELISA (enzyme-linked immunosorbent assay) tests were found to be the most commonly used methods in HIV diagnosis in the US. The majority of participants living with HIV in Kumasi (71.7%) and the US (67%) were concerned about their friends and family knowing of their HIV status. Unlike the US where patient assisted programs administered by pharmaceutical companies offer free to lowly priced HIV medication to low-income people living with HIV (PLWH), 92.7% of PLWH in Kumasi had free access to HIV medication. HIV-related stigma was an issue in both Kumasi and the US. Copyright © 2022 Mosley et al. Published by Global Health and Education Projects, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY 4.0.

Pathogenesis of obstructive sleep apnea in people living with HIV.

Obstructive sleep apnea (OSA) is highly prevalent in people living with human immunodeficiency virus (HIV) (PLWH), and it might contribute to frequently reported symptoms and comorbidities. Traditional risk factors for OSA are often absent in PLWH, suggesting that HIV or HIV medications might predispose to OSA. Therefore, we measured the anatomical and nonanatomical traits important for OSA pathogenesis in those with and without HIV. We recruited virally suppressed PLWH who had been previously diagnosed with OSA (PLWH + OSA) adherent to positive airway pressure (PAP) therapy, along with age-, sex-, and body mass index (BMI)-matched OSA controls. All participants underwent a baseline polysomnogram to assess OSA severity and a second overnight research sleep study during which the airway pressure was adjusted slowly or rapidly to measure the OSA traits. Seventeen PLWH + OSA and 17 OSA control participants were studied [median age = 58 (IQR = 54-65) yr, BMI = 30.7 (28.4-31.8) kg/m2, apnea-hypopnea index = 46 (24-74)/h]. The groups were similar, although PLWH + OSA demonstrated greater sleepiness (despite PAP) and worse sleep efficiency on baseline polysomnography. On physiological testing during sleep, there were no statistically significant differences in OSA traits (including Veupnea, Varousal, Vpassive, Vactive, and loop gain) between PLWH + OSA and OSA controls, using mixed-effects modeling to account for age, sex, and BMI and incorporating each repeated measurement (range = 72-334 measures/trait). Our data suggest that well-treated HIV does not substantially impact the pathogenesis of OSA. Given similar underlying physiology, existing available therapeutic approaches are likely to be adequate to manage OSA in PLWH, which might improve symptoms and comorbidities.NEW & NOTEWORTHY Clinical data suggest an increased risk of obstructive sleep apnea (OSA) in people living with HIV (PLWH), while OSA might account for chronic health issues in this population. We characterized the anatomical and nonanatomical OSA traits in PLWH + OSA compared with OSA controls, using detailed physiological measurements obtained during sleep. Our data suggest against a major impact of HIV on OSA pathogenesis. Available OSA management strategies should be effective to address this potentially important comorbidity in PLWH.

Optimizing Identification of People Living with HIV from Electronic Medical Records: Computable Phenotype Development and Validation.

Electronic health record (EHR)-based computable phenotype algorithms allow researchers to efficiently identify a large virtual cohort of Human Immunodeficiency Virus (HIV) patients. Built upon existing algorithms, we refined, improved, and validated an HIV phenotype algorithm using data from the OneFlorida Data Trust, a repository of linked claims data and EHRs from its clinical partners, which provide care to over 15 million patients across all 67 counties in Florida. Our computable phenotype examined information from multiple EHR domains, including clinical encounters with diagnoses, prescription medications, and laboratory tests. To identify an HIV case, the algorithm requires the patient to have at least one diagnostic code for HIV and meet one of the following criteria: have 1+ positive HIV laboratory, have been prescribed with HIV medications, or have 3+ visits with HIV diagnostic codes. The computable phenotype was validated against a subset of clinical notes. Among the 15+ million patients from OneFlorida, we identified 61,313 patients with confirmed HIV diagnosis. Among them, 8.05% met all four inclusion criteria, 69.7% met the 3+ HIV encounters criteria in addition to having HIV diagnostic code, and 8.1% met all criteria except for having positive laboratories. Our algorithm achieved higher sensitivity (98.9%) and comparable specificity (97.6%) relative to existing algorithms (77-83% sensitivity, 86-100% specificity). The mean age of the sample was 42.7 years, 58% male, and about half were Black African American. Patients' average follow-up period (the time between the first and last encounter in the EHRs) was approximately 4.6 years. The median number of all encounters and HIV-related encounters were 79 and 21, respectively. By leveraging EHR data from multiple clinical partners and domains, with a considerably diverse population, our algorithm allows more flexible criteria for identifying patients with incomplete laboratory test results and medication prescribing history compared with prior studies.

Designing HIV Testing and Self-Testing Services for Young People in Nigeria: A Discrete Choice Experiment

A third of new human immunodeficiency virus (HIV) infections occur among young people and the majority of young people living with HIV are in sub-Saharan Africa. We examined the strength of Nigerian youth preferences related to HIV testing and HIV self-testing (HIVST). Discrete choice experiments were conducted among Nigerian youth (age 14-24 years). Participants completed one of two discrete choice experiments: (1) preferred qualities of HIV testing (cost, location of test, type of test, person who conducts the test, and availability of HIV medicine at the testing site) and (2) preferred qualities of HIVST kits (cost, test quality, type of test, extra items, and support if tested positive). A random parameter logit model measured the strength of preferences. A total of 504 youth participated: mean age 21 years (standard deviation 2 years), 38% male, and 35% had a higher than secondary school education. There was a strong preference overall to test given the scenarios presented, although male individuals were less likely to test for HIV or use HIVST kits. Youth preferred HIV testing services (with attributes in order of importance) that are free, blood-based testing, available in private/public hospitals or home, for HIV medications to be available in the same location as testing, and a doctor conducts the test. Participants preferred HIVST kits (with attributes in order of importance) that are available from community health centers, free, approved by the World Health Organization, include other sexually transmitted infection testing, have the option of an online chat, and oral-based HIVST. The HIV home testing was equally preferred to testing in a hospital, suggesting a viable market for HIVST if kits account for youth preferences. Male youth were less likely to choose to test for HIV or use HIVST kits, underscoring the need for further efforts to encourage HIV testing among young male individuals.

Wie wirken Generikaquoten? Eine Analyse am Beispiel der HIV-Infektion

ZusammenfassungHintergrundDie Steuerungsinstrumente der Arzneimittelversorgung in der gesetzlichen Krankenversicherung (GKV) sind schon länger Bestandteil der gesundheitspolitischen Reformdebatte. Über die Jahre hat sich eine Gemengelage sehr verschiedener Werkzeuge herausgebildet, die zumeist auf eine Kontrolle der Arzneimittelausgaben zielen. Die Instrumente der regionalen Verordnungssteuerung fokussieren vor allem auf eine Verhaltenssteuerung des verordnenden Arztes. Zu erwähnen ist nicht zuletzt der verstärkte Einsatz von indikationsbezogenen Quoten, vorrangig Leitsubstanzen und/oder Generika/Biosimilars. Diese gibt es mittlerweile auch im Bereich des Humanen Immundefizienz-Virus (HIV), etwa die seit 2020 in Bayern und Berlin eingeführten Generikaquoten für HIV-Therapeutika.ZielstellungZiel des vorliegenden Beitrages ist es, auf Grundlage von GKV-Apothekenabrechnungsdaten das Potenzial sowie Grenzen von Generikaquotenlösungen in der HIV-Versorgung zu analysieren und Handlungsempfehlungen zu skizzieren.ErgebnisseEs zeigte sich, dass das Quotenpotenzial für Generika im patentfreien Bereich in der HIV-Versorgung bereits weitgehend ausgeschöpft wird. Dieser Umstand ist vor allem darauf zurückzuführen, dass die HIV-Verordner den Austausch durch Verzicht auf Aut-idem-Kreuze auf dem Kassenrezept unterstützen.DiskussionDas steuerungspolitische Optimum ist fast erreicht. Dies ist auf das geeignete Instrumentarium zurückzuführen, das aus dem Rahmenvertrag zur Arzneimittelversorgung und einer leitliniengerechten Wirkstoffverordnung durch den Arzt besteht – in Verbindung mit dem AMNOG(Arzneimittelmarktneuordnungsgesetz)-Verfahren und Festbeträgen. Leitlinienkonformität und (existierende) Eintablettenregime müssen beibehalten werden, damit die gute Versorgungsqualität gewährleistet bleibt.

Quality of systematic reviews in HIV: The case of clinical outcomes associated with patient medication adherence

Use of systematic reviews (SRs) as first-level evidence for guideline recommendations hinges on review quality. In particular, US guidelines for adherence-related recommendations in the treatment of human immunodeficiency virus (HIV) are not based on available SRs of adherence-outcome relationships; it is unclear why. No published studies report on the quality of SRs on HIV adherence and outcomes, which may be driving the lack of use. We describe the quality of this body of literature. Literature searches were conducted in Ovid MEDLINE, EMBASE, CINAHL, PubMed Central, the Cochrane Library, Science Citation Index, Web of Science, ScIELO Citation Index, and Ovid Emcare. Screening and quality assessments were performed in duplicate using AMSTAR 2. Funding sources and impact factors of publishing journals were also extracted, and correlations between quality rankings and numbers of critical weaknesses versus impact factors were assessed using Spearman's rank correlation coefficient. Nine SRs of 1141 records met eligibility criteria. Overall confidence in the results was critically low for most (78%) SRs. Underperformance was found across all AMSTAR 2 domains. Impact factor (a surrogate or journal reputation) did not correlate with quality. SRs do not necessarily comprise top-level evidence despite the availability of quality appraisal tools and reporting guidance, which could explain the lack of SR evidence in US HIV medication adherence-related guideline recommendations. All parties to evidence synthesis publication should require quality assessment of studies.