B/F/TAF forgiveness to non-adherence.

BACKGROUND: ART forgiveness is the ability of a regimen to maintain HIV-RNA suppression despite a documented imperfect adherence. We explored forgiveness of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). METHODS: In this retrospective cohort study pharmacy drug refills were used to calculate the proportion of days covered (PDC) as a proxy of adherence. Forgiveness was defined as the possibility to achieve a selected HIV-RNA threshold by a given level of imperfect adherence. A logistic model was applied to verify the impact of baseline variables and adherence on the virologic outcomes. RESULTS: We enrolled 420 adults. From them, 787 one-year time-periods were derived for a median cohort follow-up of 873 person/years.Most of them were males (73.1%); the most frequent risk factor for HIV infection was heterosexual contacts (49.5% of cases), followed by 22.5% MSM and 22.5% intravenous drug users. The median age of enrolled persons with HIV was 51 years (IQR 45-57 years); the median duration of HIV infection was 7.9 years (IQR 4-18 years) and the median nadir of CD4 cells was 277 cells/mcL (IQR 100-513 cells/mcL).Adherence showed a median of 0.97 (IQR 0.91-1.00), consequently only 17 time-periods (2.2%) in 17 different individuals (4.0%) showed HIV-RNA blood levels above 200 copies/ml.A PDC of 0.75 was sufficient to obtain in > 90% of cases the virologic outcome for both 200 copies/ml or 50 copies/ml. An adherence value of 0.85 obtained a positive response in virtually all subjects either for a cut-off of 50 or 200 copies/ml. CONCLUSIONS: Long-term success of ART needs effective, well tolerated, friendly regimens. Adherence remains a crucial determinant of long-term success, but suboptimal adherence levels are relatively common. Given this, an elevated forgiveness plays a relevant role to further improve long-term outcomes and should be considered a fundamental characteristic of any antiretroviral regimen. B/F/TAF has been proved to have all of these characteristics.

Impact of interrupting antiretroviral therapy started during primary HIV-1 infection on plasma neurofilament light chain protein, a marker of neuronal injury: The SPARTAC trial.

Objective: Antiretroviral therapy (ART)-conferred suppression of HIV replication limits neuronal injury and inflammation. ART interruption tests efficacy in HIV cure trials and viral rebound after ART interruption may induce neuronal injury. We investigated the impact of protocol-defined ART interruption, commenced during primary HIV-1 infection (PHI) on a biomarker of neuro-axonal injury (neurofilament light protein (NfL)), and its associations with inflammation (D-dimer and interleukin-6 (IL-6)) and HIV-1 reservoir size (total HIV-1 DNA). Design: Retrospective study measuring plasma NfL in 83 participants enrolled in SPARTAC randomised to receive 48-weeks ART initiated during PHI, followed by ART interruption. Methods: NfL (Simoa immunoassay, Quanterix™) was measured before ART, after 48 weeks on ART, and 12 weeks after stopping ART. Plasma D-dimer and IL-6, and total HIV-1 DNA in peripheral CD4+ T-cells results were available in a subset of participants. Longitudinal NfL changes were assessed using mixed models, and associations with clinical and laboratory parameters using linear regression. Results: NfL decreased following 48-weeks ART (geometric mean 6.9 to 5.8 pg/mL, p = 0.006) with no further significant change up to 12-weeks post-stopping ART despite viral rebound in the majority of participants (median 1.7 to 3.9 plasma HIV-1 RNA log10 copies/mL). Higher baseline NfL was independently associated with higher plasma HIV-1 RNA (p = 0.020) and older age (p = 0.002). While NfL was positively associated with D-dimer (n = 48; p = 0.002), there was no significant association with IL-6 (n = 48) or total HIV-1 DNA (n = 51). Conclusions: Using plasma NfL as a surrogate marker, a decrease in neuro-axonal injury was observed in a cohort of participants following ART initiation during PHI, with no evidence of neuro-axonal injury rebound following ART interruption for up to 12 weeks, despite viral rebound in the majority of participants.

An update on drug-drug interactions in older adults living with human immunodeficiency virus (HIV).

INTRODUCTION: People with HIV are living longer due to advances in antiretroviral therapy. With improved life expectancy comes an increased lifetime risk of comorbid conditions - such as cardiovascular disease and cancer - and polypharmacy. Older adults, particularly those living with HIV, are more vulnerable to drug interactions and adverse effects, resulting in negative health outcomes. AREA COVERED: Antiretrovirals are involved in many potential drug interactions with medications used to treat common comorbidities and geriatric conditions in an aging population of people with HIV. We review the mechanisms and management of significant drug-drug interactions involving antiretroviral medications and non-antiretroviral medications commonly used among older people living with HIV. The management of these interactions may require dose adjustments, medication switches to alternatives, enhanced monitoring, and considerations of patient- and disease-specific factors. EXPERT OPINION: Clinicians managing comorbid conditions among older people with HIV must be particularly vigilant to side effect profiles, drug-drug interactions, pill burden, and cost when optimizing treatment. To support healthier aging among people living with HIV, there is a growing need for antiretroviral stewardship, multidisciplinary care models, and advances that promote insight into the correlations between an individual, their conditions, and their medications.

Guideline No. 450: Care of Pregnant Women Living with HIV and Interventions to Reduce Perinatal Transmission.

OBJECTIVE: This guideline provides an update on the care of pregnant women living with HIV and the prevention of perinatal HIV transmission. This guideline is a revision of the previous guideline, No. 310 Guidelines for the Care of Pregnant Women Living With HIV and Interventions to Reduce Perinatal Transmission, and includes an updated review of the literature with contemporary recommendations. TARGET POPULATION: Pregnant women newly diagnosed with HIV during antenatal screening and women living with HIV who become pregnant. This guideline does not include specific guidance for girls/women of reproductive age living with HIV who are not pregnant. OUTCOMES: Prevention of perinatal HIV transmission is a key indicator of the success of a health care system and requires multidisciplinary care of pregnant women living with HIV. Intended outcomes include guidance on best practice in perinatal management for Canadian health care providers for pregnant women living with HIV; reduction of perinatal transmission of HIV toward a target of eradication of perinatal transmission; provision of optimal antenatal care for pregnant women to ensure the best maternal health outcomes and HIV suppression; and evidence-based support and recommendations for pregnant women living with HIV, maintaining awareness and consideration of the complex psychosocial impacts of living with HIV. BENEFITS, HARMS, AND COSTS: The perinatal transmission of HIV has significant morbidity and mortality implications for the child, with associated lifelong health care costs. Pregnancy presents an emotionally and physically vulnerable time for pregnant women as well as an opportunity to engage them in health promotion. This guidance does not include recommendations with additional costs to health care facilities compared with the previous guideline. Application of the recommendations is aimed at health benefits to both mother and child by optimizing maternal health and preventing perinatal HIV transmission. EVIDENCE: Published and unpublished literature was reviewed with a focus on publications post-2013. OVID-Medline, Embase, PubMed and the Cochrane Library databases were searched for relevant publications available in English or French for each section of this guideline. Results included systematic reviews, randomized controlled trials, and observational studies published from 2012 to 2022. Searches were updated on a regular basis and incorporated in the guideline until May 2023. Unpublished literature, protocols, and international guidelines were identified by accessing the websites of health-related agencies, clinical practice guideline collections, and national and international medical specialty societies. VALIDATION METHODS: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional recommendations). INTENDED AUDIENCE: The intended users of this guideline include obstetric care providers and infectious disease clinicians who provide care for pregnant women living with HIV. SOCIAL MEDIA SUMMARY: Updated Canadian HIV in pregnancy guideline informed by global research and tailored to Canadian healthcare needs and goals for pregnant women living with HIV and their families. SUMMARY STATEMENTS: RECOMMENDATIONS.

Cardiovascular risk factors and carotid intima-media thickness with neurocognitive dysfunction in people living with HIV on stable combination anti-retroviral therapy.

The goal of this clinical research was to determine the relationship between carotid intima-media thickness (cIMT), cardiovascular risk factors, and neuro-cognitive function in people living with HIV (PLHIV) and were on stable combination anti-retroviral therapy (cART). This is a cross-sectional study performed at a single center, including 149 patients who visited the anti-retroviral therapy center of our tertiary care hospital. Among the PLHIV of our research, 62.4% had at least one associated cardiovascular risk factor, and 61.1% of them had abnormally high cIMT (≥ 0.9 mm on any one side, p = 0.035). These factors and being the male gender (p = 0.028) were associated with a greater Framingham 10-year risk percentage. Hypercholesterolemia was observed in 30.9% of the PLHIV and a higher body mass index (≥ 25 kg/m2) was found in 26.8% of them. The cognitive impairment was milder in 71.8% of cases and moderate in 9.4% of PLHIV. The Chi-square test revealed that a higher proportion of participants who had lower HDL-C levels (p = 0.045), smokers (p = 0.029), systolic blood pressure ≥ 140 mmHg (p = 0.012), and lower educational status (p = 0.017) had a poorer cognitive performance. In our sample population, a higher prevalence of elevated cIMT, cardiovascular risk factors, and mild and moderate cognitive deficiency was observed in PLHIV, who were on stable cART. However, routine assessment of the neuropsychological functions and management of modifiable risk factors are not performed in our patients. Further exploration of the relationship between cardiovascular risks, cIMT, and cognitive impairment in PLHIV is essential to formulate the guidelines and delay the onset of neurocognitive disorders in these patients.

Perspectives of people with HIV and HIV clinicians on characteristics of antiretroviral treatment and HIV-related symptoms.

OBJECTIVES: We aimed to assess HIV symptoms from the perspective of both patients and HIV specialists and the impact of discontinuing antiretroviral treatment (ART) on symptomology. We gathered opinions from HIV specialists and people living with HIV about ideal ART parameters and treatment satisfaction. METHODS: Ex post-facto cross-sectional surveys were administered to 502 people living with HIV and 101 HIV clinicians in Spain (18 sites). RESULTS: The median age of participants with HIV was 43.2 years, 74.5% were male, and 91.6% had an undetectable viral load. The mean time since initiation of ART was 10.2 years. Between 54% and 67% of people living with HIV reported experiencing nervousness or anxiety, sadness, fatigue, sleep problems, or muscle/joint pain during the preceding 4 weeks. However, only 22%-27% of specialists acknowledged the presence of these symptoms. The most bothersome symptoms were related to mental health or the central nervous system. There were significant differences between the burden of symptoms reported by people living with HIV and those acknowledged by specialists. The symptoms that more frequently caused ART discontinuation were depression, dizziness, and sleep problems. Both people living with HIV and specialists prioritized ART efficacy and low toxicity, but their importance ratings differed for 5 of the 11 ART characteristics assessed. People living with HIV rated their satisfaction with ART at a mean (± standard deviation) of 8.9 ± 1.5 out of 10, whereas HIV specialists rated it lower, at 8.3 ± 0.7 (p < 0.001). CONCLUSIONS: Despite advances in HIV care and treatment, a large proportion of patients still experience symptoms. HIV specialists may not be fully aware of these. People living with HIV and HIV specialists are, overall, satisfied with ART. However, the importance they place on different ART characteristics may vary.

Prevalence of acquired and transmitted HIV drug resistance in Iran: a systematic review and meta-analysis.

BACKGROUND: There is no systematic review on the prevalence of HIV drug resistance (HIVDR) in Iran. We aimed to estimate the prevalence of HIVDR among people living with HIV (PLHIV) in Iran. We assessed HIVDR prevalence in antiretroviral therapy (ART) naïve PLHIV (i.e., those without a history of ART) and PLHIV receiving ART. METHOD: We systematically searched Scopus, PubMed, Web of Science, Embase, Iranian databases (Iranian Medical Research Information System, Magiran, and Scientific Information Database), the references of studies, and Google Scholar until March 2023. A random-effects model was used to calculate a point estimate and 95% confidence interval (95% CI) for the prevalence of HIVDR in PLHIV. RESULTS: Among 461 potential publications, 22 studies were included in the meta-analysis. The pooled prevalence of acquired HIVDR in PLHIV receiving ART was 34% (95% CI: 19, 50) for nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), 27% (95% CI: 15, 41) for non-nucleoside reverse transcriptase inhibitors (NNRTIs), and 9% (95% CI: 3, 18) for protease inhibitors (PIs). The pooled prevalence of acquired HIVDR in treatment failure PLHIV was 50% (95% CI: 31, 69) for NRTIs, 49% (95% CI: 29, 69) for NNRTIs, 11% (95% CI: 2, 24) for PIs, and 1% (95% CI: 0, 4) for integrase inhibitors (INIs). The pooled prevalence of transmitted HIVDR in ART-naïve people was 3% (95% CI; 1, 6) for NRTIs, 5% (95% CI: 2, 9) for NNRTIs, and 0 for PIs and INIs. CONCLUSION: The prevalence of HIVDR was relatively high in both ART-naïve PLHIV and those receiving ART. Without universal pretreatment HIVDR testing and more frequent routine HIV viral load testing among PLHIV who are on ART, the HIVDR prevalence might increase in PLHIV in Iran.

Antiretroviral Therapy Concealment Behaviors and their Association with Antiretroviral Therapy Adherence among People with HIV: Findings from the Florida Cohort Study.

Little is known about HIV medication concealment behaviors and the effect of medication concealment on antiretroviral therapy (ART) adherence among people with HIV (PWH). This study aims to (1) to describe medication concealment behaviors and factors associated with these behaviors, and (2) assess the association between medication concealment and suboptimal ART adherence. The Florida Cohort Study enrolled adult PWH from community-based clinics around the state from October 2020 to September 2022 (n = 416, 62% aged 50+, 56% male, 44% non-Hispanic Black, 18% Hispanic). Participants responded to questions about sociodemographics, stigma, ART adherence (≥ 85%), symptoms of depression, social networks and disclosure to their networks, and actions to conceal ART to avoid inadvertent disclosure of their HIV status. Analyses were conducted using multivariable logistic regressions models. The most common concealment behavior was hiding ART while having guests over (32%), followed by removing ART labels (26%), and putting ART into a different bottle (16%). Overall, 43% reported ≥ 1 behavior. In multivariable models, depressive symptoms, incomplete disclosure of HIV to close social networks, and not having a close social network were associated with ART concealment. After adjusting for risk factors for suboptimal ART adherence, endorsing hiding medication while having guests was associated with suboptimal ART adherence (aOR 2.87, 95% CI 1.15-7.55). Taking any action and other individual behaviors were not associated. ART concealment behaviors were common but did not consistently negatively influence adherence when accounting for other factors. PWH may want to receive ART medications in ways that ensure privacy and reduce the risk of inadvertent disclosure.

Mortality After Acute Coronary Syndrome in Human Immunodeficiency Virus Infection with Optimal Adherence: A Nationwide Study.

BACKGROUND: There have been few studies on the outcome of acute coronary syndrome (ACS) in human immunodeficiency virus (HIV) infection in the era when antiretroviral therapy (ART) is generalized and most of them have achieved viral suppression. Using claims data, we aimed to assess the mortality after atherosclerotic cardiovascular events in people with HIV (PWH) who maintain optimal adherence to ART. MATERIALS AND METHODS: We used claims data from the National Health Insurance of the Korea to confirm newly diagnosed PWH from 2009 to 2019, and measured ART adherence. ACS and mortality were confirmed in PWH who showed optimal adherence to ART. RESULTS: Among 7,100 PWH with optimal adherence and during 27,387 person-year of follow-up duration, ACS was confirmed in 140 (2.0%) cases, which was 1.3 times greater than statistics of the Korean general population (511.0 vs. 383.1 per 100,000). Acquired immunodeficiency syndrome, hypertension, dyslipidemia, and diabetes mellitus were associated with the development of ACS in PWH with optimal adherence. Mortality was confirmed in 10 cases, which is 7.1% overall and 2.9% when limited to myocardial infarction. It was comparable with the mortality rate of the Korean general population after myocardial infarction (8.9%). CONCLUSION: ACS prevalence was higher in PWH even when optimal adherence was maintained. However, mortality after ACS was comparable to that in the HIV-negative population.

Differential Diagnosis or Etiology: A Case Report on Amyotrophic Lateral Sclerosis-like Neuropathy Associated with HIV Infection.

BACKGROUND: Retroviruses are described as a risk factor for chronic neuropathy. However, it is still unknown if they can work as amyotrophic lateral sclerosis triggers. Over the years, some cases of this association have been described with heterogenous disclosures. CASE REPRESENTATION: This study aimed to report a case of HIV and ALS-like neuropathy and briefly discuss peculiarities of clinical aspects, such as physiopathology and treatment options. The patient underwent neurological examination associated with blood tests, electromyography, analysis of cerebrospinal fluid, and imaging studies. DISCUSSION: A non-systematic review was performed in major databases regarding the topic. The case presented mixed upper and lower motor neuron signs and was framed as a probable case of ALS following the present criteria. CONCLUSION: After a short follow-up and viral load cleansing, neurological stabilization was achieved.

HIV Pre-Exposure Prophylaxis, Blood Donor Deferral, Occult Infection, and Risk of HIV Transmission by Transfusion: A Fine Balance Between Evidence-Based Donor Selection Criteria and Transfusion Safety.

Pre- and postexposure prophylaxis for human immunodeficiency virus (HIV) are key to reducing the transmission of this virus. Furthermore, low-toxicity, long-acting formulations provide additional clinical benefits, in particular easier adherence to treatment and prevention. However, breakthrough HIV infections can occur despite the use of pre-exposure prophylaxis (PrEP), mainly due to suboptimal adherence or multi-drug resistant HIV strains. Albeit rare, PrEP breakthrough infections have also been reported in fully adherent patients. Should such breakthrough infection occur in an eligible blood donor, PrEP might suppress viremia and delay antibody seroconversion, thereby masking the infection and increasing the risk of transfusion transmission. This possibility has raised concerns in the blood transfusion community but remains little documented. Therefore, a literature search was performed to assess the state of knowledge on the risk of PrEP breakthrough infection, with a particular focus on the risk of HIV entering the blood supply. Evidently, PrEP breakthrough infections are rare, although the risk is not zero. Moreover, a fraction of individuals - including blood donors - do not disclose PrEP use according to various surveys and measurements of HIV PrEP analytes. Additionally, viremia and seroconversion may remain undetectable or close to the limit of detection for a long time after cessation of PrEP, particularly with long-acting antiretrovirals. Therefore, current recommendations to defer donors for at least 3 months after the last dose of oral PrEP or 2 years for long-acting PrEP appear justified, as they safeguard the blood supply and public trust toward the system. These recommendations help to safeguard blood safety and public trust in the blood supply.

ART-related medication errors in hospitalized people with HIV in the INSTI-era: analysis from 2 health systems in South Georgia, U.S.

ABSTRACTART-related medication errors occur at high rates in hospitalized people with HIV (PWH), but few studies included modern regimens. As such, we evaluated ART-related medication errors in hospitalized PWH in an era where use of INSTI-based regimens dominate. This multi-center, retrospective cohort included PWH at least 18 years hospitalized in South Georgia, U.S. between March 2016 and March 2018. Of those eligible for inclusion, 400 were randomly selected and included. Three hundred sixty-three inpatient ART-related medication errors occurred in 203 patients during the study period due to incorrect scheduling (44%), an incorrect or incomplete regimen (27%), and drug-drug interactions (27%). Approximately 25% of errors persisted to discharge. Medication errors were more likely to occur in patients receiving NNRTI- or PI-containing multi-tablet regimens, whereas those receiving INSTI-containing multi-tablet regimens were less likely to experience a medication error. ART-related medication errors are less likely in patients receiving INSTI-containing multi-tablet regimens. Ensuring appropriate transition of ART throughout hospitalization remains an area in need of significant improvement.

Adherence to HIV post-exposure prophylaxis in a specialized service in São Paulo, Brazil.

INTRODUCTION: The effectiveness of human immunodeficiency virus (HIV) post-exposure prophylaxis (PEP) depends on adherence to the protocol, which includes taking antiretrovirals (ARVs) and attending visits. We examined the adherence rate to antiretroviral agents and follow-up visits identifying the associated characteristics of adherence and the reasons for not attending HIV PEP consultations in a specialized service in São Paulo, Brazil. METHODOLOGY: This was a cross-sectional study with health service users who had an indication for PEP due to sexual exposure in an HIV/AIDS service from April to October 2019. The health service users were followed-up throughout the prophylaxis cycle. Adherence was determined through self-reports on antiretroviral agent use and attendance to follow-up consultations. RESULTS: Association measures were employed to identify adherence-related characteristics. The sample analyzed included 91 users. The mean age was 32.5 years old (SD = 9.8). The largest share was white-skinned (49.5%), men who have sex with other men (62.2%), male (86.8%), and undergraduate/graduate students (65.9%). Adherence totaled 56.7% and health insurance was the associated characteristic (p = 0.039). Work (55.9%), using a private service (15.2%), forgetfulness (11.8%) and considering follow-up unnecessary (11.8%) were the main reasons for not attending the follow-up appointments. CONCLUSIONS: Few users do attend HIV PEP consultations. The users without health insurance had the highest adherence percentage whereas work was mentioned as a reason for not attending HIV PEP consultations.

Government spending on antiretrovirals in Brazil and its main determinants / Gastos governamentais com antirretrovirais no Brasil e seus principais determinantes

The construction of public policies for the prevention and treatment of HIV/AIDS in Brazil is a history of struggle that unites sanitarians, researchers and activists since the 1980s. An important part of this path is linked to the production and distribution of antiretroviral drugs (ARV), initiatives to reduce the price of ARVs and civil society mobilizations for the guarantee of rights, which contributed to create one of the most successful programs to combat the disease in the country. world. Based on this history, this study aimed to analyze government spending on the acquisition of selected ARVs in the period between 2005 and 2020, making a comparison with international prices, in the light of determinants related to patent disputes, voluntary licensing, PDPs and ARV price reduction initiatives. Among other results, it was possible to observe that there was no immediate relationship between the end of the patent concession and the reduction of prices. Filings of other patent applications and the lack of nationally registered competitors, even after patent expiration, can be significant factors in maintaining high prices.

A construção de políticas públicas para a prevenção e tratamento do HIV/Aids no Brasil é uma história de luta que une sanitaristas, pesquisadores e ativistas desde os anos 1980. Parte importante desse caminho está ligado à produção e distribuição de medicamentos antirretrovirais (ARV), iniciativas de redução do preço dos ARV e mobilizações da sociedade civil pela garantia de direitos, que contribuíram para criar um dos programas mais bem-sucedidos de combate à doença no mundo. Com base nesse histórico, este trabalho teve por objetivo analisar os gastos governamentais na aquisição de ARV selecionados no período entre 2005 e 2020, fazendo uma comparação com preços internacionais, à luz dos determinantes relacionados às disputas patentárias, ao licenciamento voluntário, às PDPs e às iniciativas para redução de preços de ARVs. Entre outros resultados, foi possível observar que não houve uma relação imediata entre o fim da concessão patentária e a redução de preços. Depósitos de outros pedidos de patente e a inexistência de concorrentes registrados nacionalmente, mesmo após a expiração da patente, podem ser fatores significativos para a manutenção de altos preços.

A Korean Post-Marketing Study of Abacavir/Dolutegravir/Lamivudine in Patients with HIV-1.

BACKGROUND: Abacavir/dolutegravir/lamivudine has been indicated in Korea since 2015 for treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination. This regulatory post-marketing surveillance (PMS) study evaluated the real-life safety and effectiveness of abacavir/dolutegravir/lamivudine in patients with HIV-1 in clinical practice in Korea. MATERIALS AND METHODS: This open-label post-marketing surveillance examined data from consecutive patients (aged ≥12 years) with HIV-1 infection receiving abacavir/dolutegravir/lamivudine according to locally approved prescribing information; treatment-naïve and treatment-experienced patients were permitted. Data regarding patient demographics, medical history, clinical characteristics, medications (HIV-1 related and concomitant), resource utilization and comorbidities were extracted from patient records over a 1-year treatment period. Outcomes included safety of abacavir/dolutegravir/lamivudine (primary endpoint) and real-life effectiveness according to physician's global assessment and the proportion of patients with plasma HIV-1 RNA count <50 copies/mL at 48 weeks. RESULTS: Of 663 patients treated with abacavir/dolutegravir/lamivudine at 27 centers in Korea (June 2015 - June 2021), 656 were eligible for the safety analyses and 484 for effectiveness analyses. Patients were mostly male (94.8%) mean age was 42.2 ± 14.0 years and mean weight was 68.1 ± 11.0 kg. Adverse events (AEs, n = 656 in total) were mostly mild in severity, with the most common being nasopharyngitis (7.9%), retching (7.5%), headache (4.9%). Of 121 adverse drug reactions (ADRs), the most frequent were retching (4.4%), headache (1.8%) and dizziness (1.7%). Of 55 serious AEs, the most frequent were anogenital warts (1.1%). Of 2 serious ADRs, nothing was unexpected, and both resolved. The risk of experiencing an AE while receiving abacavir/dolutegravir/lamivudine appeared to be especially increased in patients receiving concomitant medications for other conditions. Abacavir/dolutegravir/lamivudine effectively suppressed HIV-1 (96.1% of patients had plasma HIV-1 RNA <50 copies/mL), and 99.0% of patients showed symptom improvement based on physician assessment. CONCLUSION: Results of this PMS study showed that abacavir/dolutegravir/lamivudine administered as highly active antiretroviral therapy was well tolerated and effective in patients with HIV-1 infection.

Interrelación entre Anatomía Patológica y Dermatología ilustrada mediante un caso clínico de sarcoma de Kaposi / Illustrating the relationship between Pathological Anatomy and Dermatology by means of a clinical case of Kaposi's Sarcoma

Se presenta el caso clínico de un paciente asistido en el servicio de Dermatología por tener lesión tumoral gigante en calcáneo derecho de instauración progresiva. La biopsia incisional muestra sarcoma de Kaposi endémico sin afectación visceral. El estadio tan avanzado de la enfermedad propició la evolución tórpida del paciente. El estudio histopatológico estableció el diagnóstico certero de la lesión tumoral; la biopsia fue el método auxiliar que estableció el vínculo necesario entre el examen macroscópico y microscópico de la piel, y la interrelación básico-clínica entre dos disciplinas: Anatomía Patológica y Dermatología.

We present a clinical case of a patient seen in the Dermatology service due to a progressive giant cell tumour in the right calcaneus. Incisional biopsy shows endemic Kaposi's sarcoma without visceral involvement. The advanced stage of the disease led to the torpid evolution of the patient. The histopathological study established the accurate diagnosis of the tumour lesion, the biopsy was the auxiliary method that established the necessary link between the macroscopic and microscopic examination of the skin and the basic and clinical relationship between two disciplines: Pathological Anatomy and Dermatology.

Experiences of initiating rapid antiretroviral therapy among people newly diagnosed with HIV in East London: a qualitative study.

OBJECTIVES: We aimed to explore the experiences of people who initiated rapid antiretroviral therapy (ART) within 7 days of HIV diagnosis, as part of routine care in London. METHODS: Using purposive sampling, 18 in-depth, semistructured interviews were conducted between December 2020 and September 2021 with people who started rapid ART at Barts Health NHS Trust. Participants aged 22-69 years included 15 cisgender men and three cisgender women. Five identified as heterosexual and 13 as gay and bisexual and other men who have sex with men. Ethnic identities: six White Non-UK, five White UK, three Black Caribbean, two South Asian and two East Asian. Interviews explored feelings about the new HIV diagnosis, attitudes to rapid ART including barriers to and facilitators of starting. Thematic analysis of transcribed interviews was undertaken. RESULTS: Four themes were identified: (1) being offered rapid ART is acceptable; (2) it is a way of taking control of their health; (3) the need for information and support and (4) an individualised approach to care. Reasons for starting included getting well, staying well and reducing the likelihood of passing on HIV. Facilitators included being given comprehensive information about treatment and managing potential side-effects and a supportive clinical team. Support specified included a non-judgemental attitude, approachability, reassurance, encouragement and information about peer support. Most participants expressed they could not understand why people would not begin treatment, but suggested needing more time to decide and denial of diagnosis as possible barriers. CONCLUSIONS: To our knowledge, this is the first qualitative study exploring the experiences of people initiating rapid ART in the UK. It was deemed acceptable to an ethnically diverse, predominantly male sample of people newly diagnosed with HIV. Future research should include strategies to recruit a more gender diverse sample and those who declined or stopped rapid ART.

Motivations for blood donation by HIV-positive individuals on antiretrovirals in South Africa: A qualitative study.

OBJECTIVES: We performed a mixed-methods study to explore the motivations associated with blood donation by donors with known, but undisclosed HIV-positive status and ARV use (HIV+/ARV+), seeking potential strategies to reduce such donations and mitigate risk for blood recipients. Here, we report predominantly the qualitative component. BACKGROUND: A safe and sustainable blood supply is dependent in part, on effective pre-donation donor assessment. We previously described failure by HIV+/ARV+ blood donors to disclose their status. Such donations may lead to transfusion-transmitted HIV. METHODS: The social ecological model provided the conceptual framework for this study. Previously identified HIV+/ARV+ donors were invited to complete a survey (including a validated stigma scale) and qualitative interview, which underwent inductive and deductive thematic analysis. RESULTS: We uncovered two primary motivational paths to HIV+/ARV+ blood donations: privacy and altruism. The latter included a motivation not previously reported in the literature: donating specifically for other people living with HIV (PLWH). The other primary factor was a lack of privacy. These accounts often included donors encountering donation opportunities when accompanied by people to whom they had not and did not plan to disclose their HIV status. Most were highly confident their donations would be identified as HIV-positive and discarded. CONCLUSION: We demonstrated a complex interaction between individual, social, cultural, and structural/policy factors in blood donations by PLWH who take ARV. Recommendations to limit HIV + ARV+ donations include: (1) Targeted communication strategies to increase knowledge among PLWH of their deferral from blood donation-without increasing stigma, and (2) development of procedures to assist those who feel unable to opt-out of donation due to privacy concerns.

Clinical significance of human endogenous retrovirus K (HERV-K) in multiple myeloma progression.

Human endogenous retroviruses (HERVs) are retrotransposons that infect human germline cells and occupy 5-8% of the human genome. Their expression, though inhibited by mutation, deletion, and epigenetic mechanisms under normal conditions, is associated with diseases including cancer. This study aimed to clarify the association between HERVs and multiple myeloma (MM) progression. We found that HERV-K envelope (env) and long-term repeat (LTR) expression was statistically significantly higher within plasma cells in MM than in monoclonal gammopathy of undetermined significance or controls. HERV-K env knockdown increased proliferation in the MM.1S cell line and decreased the expression of the tumor suppressor genes TP53 and CDKN1A. TP53 and CDKN1A were highly expressed in MM, and their expression was correlated with HERV-K expression. HERV-K knockdown reduced apolipoprotein B mRNA editing enzyme catalytic polypeptide-like 3F, 3G, and 3H expression by 10-20% in MM.1S cells. The anti-retroviral agents nevirapine and nelfinavir suppressed proliferation and increased HERV-K expression in MM cell lines. Our results suggest that HERV-K is involved in MM progression, but its role is likely to go beyond promoting cell proliferation. Clarifying the role of HERV-K in MM will lead to the discovery of novel treatment strategies and supply new insights into MM pathogenesis.

Cytogenetic changes in oral mucosa cells from individuals submitted to oral human immunodeficiency virus pre-exposure prophylaxis use

SUMMARY OBJECTIVE: The objective of this study was to evaluate cytogenetic changes in individuals submitted to oral human immunodeficiency virus pre-exposure prophylaxis use through the micronucleus test in oral mucosa. METHODS: This study consisted of 37 individuals, of whom 17 comprised the pre-exposure prophylaxis group and 20 comprised the control group. A total of 2,000 cells per slide were analyzed for the determination of micronuclei, binucleation, nuclear buds, and cytotoxicity parameters: pyknosis, karyolysis, and karyorrhexis (KR), in a double-blind manner. The repair index was also evaluated in this setting. RESULTS: In the mutagenicity parameters, the pre-exposure prophylaxis group showed increased frequencies of micronuclei (p=0.0001), binucleation (p=0.001), and nuclear buds (p=0.07). Regarding the cytotoxicity parameters, there was an increase with a statistical difference (p≤0.05) in the karyorrhexis frequency (p=0.001). Additionally, the repair system efficiency decreased in the pre-exposure prophylaxis group. CONCLUSION: These results indicate that individuals undergoing pre-exposure prophylaxis use have geno- and cytotoxicity in oral mucosal cells.