Week 96 Results of Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV Treatment in People With Substance Use Disorders.

Background: The BASE study (NCT03998176), a phase 4, 48-week (W), single-arm, prospective trial, revealed that the use of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with HIV and substance use disorders (PWH/SUD) was safe and effective without emergent antiretroviral resistance despite incomplete adherence. Here, we present the W96 results.

Methods: A retrospective analysis of all participants enrolled in the BASE study was completed from W48 to W96.

Doxycycline as Post-Exposure Prophylaxis: Awareness, Beliefs, and Interest Among Patients with and at Risk for HIV.

Recent studies have demonstrated the efficacy of doxycycline as post-exposure prophylaxis (doxy-PEP) for sexually transmitted infection (STI) prevention, but little is known regarding patient beliefs and interest in doxy-PEP. We conducted a cross-sectional survey of adults (≥ 19 years) receiving care for HIV treatment (PWH) or prevention (pre-exposure prophylaxis, PrEP) between May-October 2023. The 32-question survey was organized into three parts: doxy-PEP awareness/beliefs/interest/concerns, sexual history, and demographics.

Long-Acting Cabotegravir/Rilpivirine Concentrations in Combination With Intravenous Rifampin: A Case Report.

As antiretroviral therapy advancements focus on long-acting medications, there is a need to assess the potential impact of drug-drug interactions. We present a real-world case of long-acting cabotegravir/rilpivirine co-administered with intravenous rifampin. The combination resulted in both cabotegravir and rilpivirine concentrations falling below 4 times the protein-adjusted IC.

Acceptability, Feasibility, and Appropriateness of Implementation of Long-acting Injectable Antiretrovirals: A National Survey of Ryan White Clinics in the United States.

Background: The approval of long-acting injectable cabotegravir/rilpivirine (LAI CAB/RPV) heightened the urgency of ensuring effective implementation. Our study assesses readiness and barriers to implement LAI CAB/RPV across Ryan White-funded clinics in the United States.

Methods: We conducted a cross-sectional survey between December 2020 and January 2021 using validated 4-item measures: acceptability of intervention measure (AIM), intervention appropriateness measure (IAM), and feasibility of intervention measure (FIM).

Patient perspectives of antiretroviral pharmacy services: A cross-sectional cohort study.

Background: Adherence to antiretroviral therapy (ART) remains the main predictor of sustained HIV virologic suppression for people with HIV (PWH). Mail-order pharmacy services are often offered to patients as an alternative option to traditional pharmacy services. Some payers mandate ART to be dispensed from specific mail-order pharmacies regardless of patient choice complicating ART adherence for patients affected by social disparities.

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Patients With HIV-1 Infection and Ongoing Substance Use Disorder: The BASE Study.

Background: People with human immunodeficiency virus (HIV) and substance use disorder (PWH/SUD) are at higher risk of nonadherence to antiretroviral therapy. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) exhibits high rates of efficacy with a favorable adverse event profile. The BASE study (NCT03998176) is a phase 4, single-arm study evaluating the effectiveness and safety of B/F/TAF among PWH/SUD.

Antiretroviral Refill Histories as a Predictor of Future Human Immunodeficiency Virus Viremia.

Background: The use of adherence measures as markers for virologic failure (VF) has been studied. Yet, there is currently no single adherence metric recommended for VF. Antiretroviral prescription refill histories, for people living with human immunodeficiency virus (HIV), are readily accessible and can be easily quantified to an estimated adherence level.

Successful application of pharmacogenomic testing in the evaluation and management of a patient with human immunodeficiency virus and disseminated histoplasmosis.

Objectives: To demonstrate the successful use of pharmacogenomic testing to specifically tailor antifungal treatment to the phenotype of a patient with human immunodeficiency virus (HIV) and disseminated histoplasmosis who had clinical progression while on itraconazole and subsequently had insufficient therapeutic drug levels of voriconazole.

Case Summary: We present the case of a patient with HIV and disseminated histoplasmosis with a persistently elevated serum Histoplasma capsulatum antigen and subtherapeutic levels of voriconazole. Pharmacogenomic testing revealed he was a CYP2C19 rapid metabolizer, thus explaining his persistent, subtherapeutic levels of voriconazole and prompting a change in therapy.

Acute Weight Gain After Switch to Emtricitabine/Tenofovir Alafenamide for Human Immunodeficiency Virus Pre-Exposure Prophylaxis.

We report a case of acute weight gain after switching from emtricitabine/tenofovir disoproxil to emtricitabine/tenofovir alafenamide for human immunodeficiency virus pre-exposure prophylaxis.

Impact of Pharmacy Type on HIV Viral Suppression: A Retrospective Cross-Sectional Cohort Study.

Background: People with HIV (PWH) use various pharmacy types beyond traditional local pharmacies. Some specialized pharmacies offer additive adherence services such as refill reminders, expedited delivery, and adherence packaging.

Methods: This single-center, retrospective cohort study evaluated the impact of pharmacy type on the gain or loss of HIV viral suppression (VS; HIV RNA ≤50 copies/mL).

HIV-1 Integrase Inhibitors: A Comparative Review of Efficacy and Safety.

The newest class of antiretrovirals for all persons living with HIV are the integrase strand transfer inhibitors (INSTIs). Since 2007, five INSTIs have been introduced: raltegravir, elvitegravir, dolutegravir, bictegravir, and cabotegravir. The INSTIs have favorable pharmacokinetic and pharmacodynamic properties, which contribute to both their effectiveness and their ease of use.

Sustained Virologic Suppression After 4 Weeks of Ledipasvir/Sofosbuvir in Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Co-Infection.

BACKGROUND Short-course hepatitis C (HCV) treatment with direct-acting antivirals (DAA) under 8 weeks in duration has resulted in variable efficacy rates in HCV mono-infection. Further, DAA courses under 8 weeks in duration have not been studied in HIV/HCV co-infection. We present a case report of 12-week sustained virologic suppression after treatment interruption of ledipasvir/sofosbuvir at 4 weeks in a patient with HIV/HCV co-infection.

Plasma and intracellular pharmacokinetics of tenofovir disoproxil fumarate and emtricitabine in transgender women receiving feminizing hormone therapy.

Background: Transwomen have an increased risk of HIV acquisition compared with other adults. Drug-drug interactions between pre-exposure prophylaxis (PrEP) and gender-affirming therapy are cited as a reason for poor PrEP uptake among transwomen. We evaluated plasma tenofovir and emtricitabine pharmacokinetics and their active intracellular anabolites, tenofovir-diphosphate and emtricitabine-triphosphate, in transwomen receiving feminizing hormones.

Clinical Pharmacokinetics and Pharmacodynamics of Etravirine: An Updated Review.

Etravirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of human immunodeficiency virus type 1 infection. It is a potent inhibitor of HIV reverse transcriptase and retains activity against wild-type and most NNRTI-resistant HIV. The pharmacokinetic profile of etravirine and clinical data support twice-daily dosing, although once-daily dosing has been investigated in treatment-naïve and treatment-experienced persons.

Acceptability and feasibility of a pharmacist-led HIV pre-exposure prophylaxis (PrEP) program in the Midwestern United States.

Background: HIV pre-exposure prophylaxis (PrEP) substantially reduces the risk of HIV acquisition, yet significant barriers exist to its prescription and use. Incorporating pharmacists in the PrEP care process may help increase access to PrEP services.

Methods: Our pharmacist-led PrEP program (P-PrEP) included pharmacists from a university-based HIV clinic, a community pharmacy, and two community-based clinics.

Midwest pharmacists' familiarity, experience, and willingness to provide pre-exposure prophylaxis (PrEP) for HIV.

Introduction: Pharmacist provision of pre-exposure prophylaxis (PrEP) through collaborative practice agreements with physicians could expand access to people at risk for HIV. We characterized pharmacists' familiarity with and willingness to provide PrEP services in Nebraska and Iowa.

Methods: An invitation to complete an 18-question survey was emailed to 1,140 pharmacists in Nebraska and Iowa in June and July of 2016.

A pharmacist-led medication switch protocol in an academic HIV clinic: patient knowledge and satisfaction.

Background: Tenofovir alafenamide (TAF) is associated with less renal and bone toxicity compared with tenofovir disoproxil (TDF). TAF's recent FDA approval has spurred HIV providers to consider switching antiretroviral therapy (ART) regimens containing TDF to TAF to minimize long term risks. Patient views on the process of such medication switches have not been explored.

Plasma and intracellular pharmacokinetics of tenofovir in patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide.

Objectives: The aim of the study was to compare the intraindividual plasma and intracellular peripheral blood mononuclear cell (PBMC) pharmacokinetics of tenofovir (TFV) and its intracellular metabolite, TFV-diphosphate (TFV-DP) in patients switched from a fixed-dose combination (FDC) tablet of TFV disoproxil fumarate (TDF)/emtricitabine (FTC)/elvitegravir (EVG)/cobicistat (COBI) to a FDC containing TFV alafenamide (TAF)/FTC/EVG/COBI.

Design: A single-arm, prospective, nonrandomized, cross-over, pharmacokinetic study in patients receiving a TDF-containing regimen (TDF 300 mg/FTC 200 mg/EVG 150 mg/COBI 150 mg) switched to a TAF-containing FDC regimen (TAF 10 mg/FTC 200 mg/EVG 150 mg/COBI 150 mg).

Methods: Single, sparse plasma and PBMC samples were collected during TDF therapy and 4-8 weeks post-switch to the TAF-containing regimen.