Gender Affirming Hormones Do Not Affect the Exposure and Efficacy of F/TDF or F/TAF for HIV Preexposure Prophylaxis: A Subgroup Analysis from the DISCOVER Trial.

Purpose: Transgender women are disproportionately affected by HIV and are underutilizing preexposure prophylaxis (PrEP). The lower uptake of PrEP by transgender women may be, in part, owing to the perception that taking PrEP may lower the efficacy of gender-affirming hormone therapy (GAHT) or to provider concerns that GAHT may lower the efficacy of PrEP. Methods: DISCOVER was a randomized, double-blind, noninferiority trial comparing emtricitabine (FTC, F) and tenofovir alafenamide (F/TAF) versus emtricitabine and tenofovir disoproxil fumarate (F/TDF) as PrEP among transgender women and cisgender men who have sex with men (MSM). This nested substudy of the DISCOVER trial compared the exposure of the active intracellular metabolites of FTC and tenofovir (TFV), FTC triphosphate (FTC-TP) and TFV diphosphate (TFV-DP), in peripheral blood mononuclear cells (PBMC) among transgender women receiving GAHT versus MSM within the F/TAF and F/TDF groups. Results: Our results demonstrate that TFV-DP and FTC-TP levels in PBMC were comparable between transgender women on GAHT and MSM receiving F/TAF, and between transgender women on GAHT and MSM receiving F/TDF. TFV-DP concentrations remained above the EC90 of 40 fmol/106 cells across all groups. No clinically significant drug-drug interactions of GAHT were observed with either F/TAF or F/TDF in this subanalysis. Conclusions: These findings are consistent with the clinical pharmacology of GAHT, FTC, TDF, and TAF reported in previous studies, and support the continued use of F/TAF and F/TDF for PrEP in transgender women.Clinicaltrials.gov registration number: NCT02842086.

Evaluation of an HIV Pre-Exposure Prophylaxis Referral System: From Sexual Health Center to Federally Qualified Health Center Pre-Exposure Prophylaxis Clinic.

Innovative delivery strategies are needed to facilitate access to HIV pre-exposure prophylaxis (PrEP). The objective of this study was to evaluate a navigator-facilitated PrEP referral process from a sexual health center (SHC) to a co-located PrEP clinic as an alternative delivery model. Electronic health record (EHR) data were used to calculate the number of clients seen at the SHC in 2019. Charts were manually reviewed to determine whether a PrEP clinic referral was made and document type of referral method: face-to-face appointment scheduling with the navigator (warm handoff), EHR messaging to navigator to schedule the appointment at a later time (EHR message), or provision of navigator's contact information to the client (card only). In 2019, 2481 unique potentially PrEP-eligible clients were seen at the SHC; 220 (9%) received a PrEP referral. Of referred clients, median age was 30 years (interquartile range, 24-34), 182 (83%) were male, 89 (40%) were non-Hispanic Black, and 24 (11%) were Latinx. In total, 94/220 (43%) referred clients attended an initial PrEP visit with a provider, and the proportion attending by referral method was 81%, 36%, and 27% for warm handoff, EHR message, and card only, respectively (p < 0.0001). Despite co-location of these two clinics, there were significant drop-offs along the PrEP care continuum for this referral system. Warm handoff was the most effective referral method, but further efforts are needed to understand barriers to referral. Implementation of same-day PrEP services at SHCs is one potential solution to engaging additional clients.

The Vital Role of a Federally Qualified Community Health Center in New Orleans, Louisiana, During the COVID-19 Pandemic.

Federally qualified health centers (FQHCs) are on the front lines of the COVID-19 pandemic. Their mission of providing essential medical care to underserved populations is now even more vital. CrescentCare, an FQHC in New Orleans, evaluated and tested 3366 patients between March 16 and July 2, with an overall rate of 12% SARS-CoV-2 positivity. The clinic's experience demonstrates how to effectively and rapidly integrate COVID-19 programing, while preserving essential health services. Strategies include developing a walk-in COVID-19 testing site, ensuring appropriate clinical evaluation, providing accurate public health information, and advocating for job safety on behalf of our patients.

Race, Heart Rate, and Temperature Are Strongly Associated With COVID-19 at a Community-based Clinic in New Orleans.

Federally qualified health centers are on the frontlines of the coronavirus disease 2019 (COVID-19) pandemic in the United States. It is essential to develop the workflows necessary to evaluate patients, perform appropriate diagnostics, make clinical recommendations, and provide public health messaging. This brief report presents findings from our COVID-19 response and compares the characteristics between the 345 patients screened between March 16 and April 10, 2020. One hundred seventeen patients tested positive for COVID-19, an overall rate of 33.9%; and Black race, increased heart rate, elevated temperature, and the use of antipyretic agents were associated with positive results.

A Care Continuum of Immediate ART for Newly Diagnosed Patients and Patients Presenting Later to Care at a Federally Qualified Health Center in New Orleans.

Rapid-start, immediate antiretroviral therapy (ART) initiation is a novel intervention that leads to earlier viral suppression. Longer-term data is essential before supporting this strategy more widely. CrescentCare, a federally qualified health center in New Orleans, followed 195 patients who received same-day ART; here we present a continuum of care for immediate ART intervention.

Early HIV Diagnosis Leads to Significantly Decreased Costs in the First 2 Years of HIV Care in an Urban Charity Hospital in New Orleans.

We undertook a retrospective cohort study of patients with a positive HIV test in the emergency department who were then linked to care. Inpatient, outpatient, and emergency costs were collected for the first 2 years after HIV diagnosis. Fifty-six patients met the inclusion criteria; they were predominantly uninsured (73%) and African American (89%). The median total cost for a newly diagnosed patient over the first 2 years was US$36 808, driven predominantly by outpatient costs of US$17 512. Median inpatient and total costs were significantly different between the lowest (<200 cells/mm3) and highest (>499 cells/mm3) CD4 count categories (US$21 878 vs US$6607, P <.05; US$61 378 vs US$18 837, P <.05, respectively). Total costs were significantly different between viral load categories <100 000 HIV-RNA copies/mL and ≥100 000 HIV-RNA copies/mL (US$28 219 vs US$49 482, P <.05). Costs were significantly lower among patients diagnosed earlier in their disease. Decreased cost is another factor supporting early diagnosis and linkage to care for patients with HIV.

Laboratory markers slightly overestimate retention in HIV care among newly diagnosed individuals.

Patients who are retained in HIV care have a higher likelihood of viral suppression and increased survival. Lab markers have been used as surrogate markers for clinical visits to estimate retention, but the accuracy of these markers at predicting retention in care has not been validated. A retrospective cohort study was conducted using patients newly diagnosed with HIV in the Emergency Department of Interim Louisiana Public Hospital (ILPH). Retention in care was defined as two clinical visits to an HIV provider separated by at least three months within a one-year period as per the Health Resources and Services Administration (HRSA) definition. Retention by lab markers was defined as two documented labs, either a CD4 count or an HIV viral load, separated by at least three months within the same one-year period. Ninety-nine patients were newly diagnosed with HIV; 36 patients (36%) were retained at 1 year using the HRSA definition and 40 patients (40%) using lab markers. The sensitivity and specificity of using lab markers among the newly diagnosed were 100% and 93.7%, respectively. The positive predictive value (PPV) and negative predictive value (NPV) were 90% and 100%, respectively. Among the 99 patients, 56 were linked to the HIV clinic associated with our hospital, of which 63% (36) were retained at year 1 using the HRSA definition and 70% (39) using lab markers. The sensitivity and specificity of using lab markers among linked patients were 100% and 85%, respectively. The PPV and NPV were 92% and 100%, respectively. Lab markers slightly overestimate currently accepted definitions of retention. While lab markers may be the easiest way to estimate retention at the population level, further study should be done before lab markers are accepted as the gold standard surrogate measure for retention.

Toxicity and disease-related outcomes after radiotherapy for head and neck cancer in human immunodeficiency virus-positive patients.

BACKGROUND: Human immunodeficiency virus (HIV) seropositivity may be associated with higher risk of local recurrence and poor survival in multiple malignancies. However, long-term disease control in HIV-positive patients with head and neck cancer (HNC) is not well described. The purpose of this study is to review the disease-related outcomes of HIV-positive patients who underwent radiotherapy (RT) or chemoradiotherapy (CRT) at our institution. METHODS: We retrospectively reviewed 24 HIV-positive patients who underwent RT for HNC between 2004 and 2013. Patient characteristics, treatment details, and outcomes were collected. Overall survival (OS) and local recurrence-free survival (LRFS) were investigated. Kaplan-Meier estimated survival was calculated. RESULTS: Median follow-up was 21 months. All patients were treated with curative intent. Eighty-three percent had stage III-IV. Primary sites of disease included oropharynx (n = 12), larynx (n = 6), oral cavity (n = 2), unknown primary (n = 2), nasal cavity (n = 1), and paranasal sinuses (n = 1). Four patients (17%) had definitive RT alone and nine had definitive CRT (38%; eight cisplatin and one cetuximab). Eleven (46%) were treated in the adjuvant setting after surgical resection; six with RT alone and five with concurrent cisplatin. Eight patients had acute Grade 3 toxicity with no acute Grade 4 or 5 toxicities. Fifteen patients (63%) were alive and disease-free. Two- and 5-year OS was 67 and 59%, respectively. LRFS at 2-years was 82%. Median OS was 83 months. CONCLUSION: In this cohort, HIV-positive patients treated aggressively with curative intent had excellent OS and local control following RT or CRT for HNC compared to historical controls. Treatment was relatively well tolerated. This group of patients should be managed aggressively with intent to cure.

Acute human immunodeficiency virus infection.

The clinical spectrum of acute human immunodeficiency virus (HIV) infection, a common clinical syndrome, may range from asymptomatic to a severe illness. The purpose of this review is to increase awareness of this syndrome, which is rarely suspected and often missed in clinical care settings, and provide an informative reference for primary care providers. The diagnosis of acute HIV infection is important for both patient care and public health concerns. In this article, the epidemiology, pathophysiology, clinical presentation, diagnosis and treatment of acute HIV infection are reviewed.

The modern day masquerader: a rare case of acute HIV infection with neurologic complications and a review of the literature.

Our case demonstrates a rare presentation of acute HIV infection (AHI) with myoclonus, rhabdomyolysis, and aseptic meningitis. It is imperative for primary care physicians to consider AHI. In this patient, laboratory findings demonstrated infection three to four months before presentation. The diagnosis of AHI is critical for early intervention and for decreasing transmission. We review the CNS manifestations of AHI, the laboratory stages of AHI, and discuss treatment options.