Protocol for the development of a consensus practice guideline To address clinical and regulatory barriers to buprenorphine dispensing in community pharmacy.

BACKGROUND: Less than half of community pharmacies in the United States stock buprenorphine products indicated for the treatment of opioid use disorder. This lack of access to buprenorphine in community pharmacies is a significant barrier to care. To address this issue, this protocol outlines a comprehensive approach to develop a practice guideline aimed at improving access to safe and effective opioid use disorder treatment in community pharmacies. METHODS: The guideline development process will proceed in three phases, following a technique closely aligned with the Institute of Medicine's guidance on guideline development. The first phase will involve conducting qualitative interviews with pharmacists in three states to identify their beliefs toward buprenorphine dispensing. As limitations on buprenorphine supply are related to constraints at all levels of the drug supply and regulatory system, the second phase, we will recruit representatives from regulatory agencies, pharmacy organizations, the Drug Enforcement Administration, pharmaceutical wholesalers as well as addiction medicine physicians and psychiatric pharmacists to develop consensus recommendations through a modified Delphi design. This will be followed by a public comment period and external expert review of the recommendations led by the National Association of Boards of Pharmacy. Finally, in the third phase, a national, mixed media dissemination campaign will be led by the National Community Pharmacists Association (NCPA) to convey recommendations to practicing pharmacists. DISCUSSION: The guideline development process aims to incorporate the perspectives of multiple stakeholders and emphasize the importance of addressing the regulatory and pharmacy-specific aspects of care in addition to clinical evidence and guidance. The development of this guideline will provide targeted, multidisciplinary guidance for pharmacists, improving access to safe and effective opioid use disorder treatment in the community setting. PREREGISTRATION: This protocol was registered with the Open Science Framework in March of 2023. Registration may be found at: https://doi.org/10.17605/OSF.IO/6S9DY .

Case Series of People With HIV on the Long-Acting Combination of Lenacapavir and Cabotegravir: Call for a Trial.

Background: Injectable cabotegravir (CAB)/rilpivirine (RPV) is the only combination long-acting (LA) antiretroviral regimen approved for HIV. RPV may not be effective among individuals with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance, which has >10% prevalence in many countries. Lenacapavir (LEN) is an LA capsid inhibitor given every 6 months, but has not been studied in combination with other LA agents. Methods: We assembled a case series from 4 US academic medical centers where patients with adherence challenges were prescribed LEN subcutaneously every 26 weeks/CAB (+/- RPV) intramuscularly every 4 or 8 weeks. Descriptive statistics, including viral load (VL) outcomes, were summarized. Results: All patients (n = 34: 76% male; 24% cis/trans female; 41% Black; 38% Latino/a; median age [range], 47 [28-75] years; 29% and 71% on CAB every 4 or 8 weeks) reported challenges adhering to oral ART. The reasons for using LEN/CAB with or without RPV were documented or suspected NNRTI mutations (n = 21, 59%), integrase mutations (n = 5, 15%), high VL (n = 6, 18%), or continued viremia on CAB/RPV alone (n = 4, 12%). Injection site reactions on LA LEN were reported in 44% (32% grade I, 12% grade 2). All patients but 2 (32/34; 94%) were suppressed (VL <75 copies/mL) after starting LEN at a median (range) of 8 (4-16) weeks, with 16/34 (47%) suppressed at baseline. Conclusions: In this case series of 34 patients on LEN/CAB, high rates of virologic suppression (94%) were observed. Reasons for using LEN/CAB included adherence challenges and underlying resistance, mostly to NNRTIs. These data support a clinical trial of LEN/CAB among persons with NNRTI resistance.

GLP-1 Receptor Agonists Promote Weight Loss Among People with HIV.

BACKGROUND: Weight gain and associated metabolic complications are increasingly prevalent among people with HIV (PWH). Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are incretin-based therapies for diabetes and weight management that have been shown to result in substantial weight loss; however, studies of their effects in PWH are limited. METHODS: A retrospective single-center cohort study was conducted among PWH who were taking GLP-1RAs at UC San Diego Owen Clinic between 2/1/2021 to 2/1/2023. Baseline clinical data were collected and changes in weight, body mass index (BMI), and hemoglobin A1C (A1C) before starting GLP-1RAs compared to the most recent clinic visit were calculated (with a minimum of 3 months follow-up time required). Logistic regression was performed to identify variables associated with >5% of total body weight loss. RESULTS: A total of 225 patients received on average 13 months of GLP-1RA therapy, with 85 (37.8%) achieving the maximum GLP-1RA dose. GLP-1RA therapy resulted, on average, in a loss of 5.4 kg, decrease in BMI by 1.8 kg/m2, and decrease in A1C by 0.6%. In the multivariable analysis, higher baseline BMI [OR 1.10 (1.03-1.16)], treatment duration of GLP-1RA therapy greater than 6 months [OR 3.12 (1.49-6.49], and use of tirzepatide [OR 5.46 (1.44-20.76)] were significantly more likely to be associated with >5% weight loss. CONCLUSIONS: Use of GLP-1RAs led to declines in weight, BMI, and hemoglobin A1C among PWH and offers an additional strategy to address weight gain and diabetes.

Relationships Between Stigma, Risk Tolerance, and Buprenorphine Dispensing Intentions Among Community-Based Pharmacists: Results From a National Sample.

BACKGROUND: Concerns have been raised that pharmacists sometimes act as barriers to patients with opioid use disorder (OUD) accessing buprenorphine treatment. The present research explores how community pharmacists' endorsement (vs non-endorsement) of stigmatizing beliefs about patients taking buprenorphine relate to intentions, comfort, and decisions regarding dispensing buprenorphine for OUD. In addition, we assessed attitudes toward risk in pharmacy practice as a novel correlate of dispensing intentions and decisions. METHODS: A sample of 207 active community-based pharmacists practicing in the United States responded to survey items measuring stigma, risk tolerance, and intentions to dispense buprenorphine. The survey included 2 vignettes in which patients presented to the pharmacy with a prescription for buprenorphine, and respondents rated their comfort with dispensing and decisions regarding dispensing in the vignette. RESULTS: Results suggest that both stigma toward patients taking buprenorphine to treat OUD and tolerance for risk in pharmacy settings are related to differences in pharmacists' intentions to and willingness to dispense buprenorphine for OUD. CONCLUSIONS: Findings support the need for interventions to reduce stigma associated with buprenorphine use among pharmacists and suggest that risk tolerance is an important determinant of pharmacists' behavior that merits further study.

Effects of a hospital discharge clinic among people with HIV: Lack of early follow-up is associated with 30-day hospital readmission and decreased retention in care.

BACKGROUND: The transition between inpatient and outpatient care for hospitalized people with HIV represents an opportunity for linkage and re-engagement in care. We evaluated whether attendance at a post-hospitalization visit ('discharge clinic') within 1-2 weeks of discharge would reduce readmissions and improve retention in care (RIC) among people with HIV in San Diego, California, USA. METHODS: This was a retrospective cohort study of people with HIV hospitalized between June 2020 and November 2021. Our primary outcome was 30-day readmissions among people with HIV who did or did not attend a discharge clinic visit. Secondary outcomes included the effect of discharge clinic attendance on RIC, along with the impact of attendance at any HIV clinic visit within 30 days of discharge on readmissions and RIC. RESULTS: We evaluated 114 people with HIV, of whom 77 (67.5%) and 90 (78.9%) attended a discharge clinic visit or any HIV clinic visit within 30 days of discharge, respectively. Active substance use disorder (SUD) was associated with failing to attend a discharge clinic visit (odds ratio 0.31; 95% confidence interval 0.13-0.77). We observed no significant differences in readmissions between people with HIV who did or did not attend a discharge clinic visit; however, the former had significantly higher 6-month RIC (79.2% vs. 35.1%, p < 0.001). People with HIV attending any HIV clinic visit within 30 days of discharge had significantly fewer 30-day readmissions (8.9% vs. 29.2%, p = 0.02) and better 6-month RIC (75.6% vs. 25%, p < 0.001) than those who did not attend. CONCLUSION: Early hospital follow-up care was associated with a reduction in readmissions among people with HIV. Active SUD was a significant barrier to linkage to outpatient follow-up and RIC.

Predictors of Post-switch Viremia in People With HIV on Injectable Cabotegravir/Rilpivirine.

BACKGROUND: Predictors of virologic failure in those receiving long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) have been evaluated; however, factors associated with low-level viremia, including blips and persistent low-level viremia (pLLV), are not well-described. METHODS: A retrospective cohort study was performed using data from April 2021 through December 2022. Inclusion criteria included treatment with CAB/RPV for at least 3 months, availability of pre- and postswitch HIV RNA values, HIV RNA value of <200 copies/mL (cpm) at the time of switch to CAB/RPV, and at least 1 postswitch HIV RNA collected >21 days after the start of CAB/RPV. Outcomes included incidence of HIV RNA ≥20, ≥50, and ≥200 cpm after switch and factors associated with detectable HIV RNA after switch. RESULTS: The median duration of follow-up among 144 participants was 287 days. After switching to CAB/RPV, occurrences of at least 1 HIV RNA ≥20, ≥50, and ≥200 cpm after switch were 34.7%, 15.3%, and 2.8%, respectively. Those with pLLV before switch were significantly more likely to have detectable HIV RNA after switch [hazard ratio 24.39 (8.71-68.34)], and 44.4% of those with pLLV before switch continued with pLLV after switch to LAI CAB/RPV. Body mass index, late injection, and monthly versus every two-month dosing were not associated with detectable viremia after switch. CONCLUSIONS: Despite virologic suppression at the time of switch and the perceived adherence benefits, participants still experienced blips or pLLV after switch to LAI CAB/RPV. Having detectable HIV RNA on oral therapy before switch was associated with detectable HIV RNA after switching.

Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy.

In the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD. The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes. Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.

The Impact of Number of Medications on Falls in Aging Persons with Human Immunodeficiency Virus.

We aimed to evaluate the impact of polypharmacy on the risk of having a fall in older persons with HIV (PWH). PWH at least 50 years of age who were seen at our institution from September 2012 to August 2017 were included. Unique participants were selected for either a case or control cohort depending on the presence of a documented fall during the study time period. Demographics, HIV-related measures, VACS score, number of medications, as well as the impact of taking benzodiazepines and opioids were compared between the two cohorts. Fall was documented for 637 patients compared to 1534 without a fall during the same time period. Multivariable logistic regression revealed that the total number of medications, having a higher VACS score, taking an opioid, being female sex assigned at birth, and having a lower nadir CD4 count were significantly associated with higher odds of having a fall. In this cohort of older PWH, taking a higher number of non-ARV medications significantly increased the odds of having a fall. In addition, taking an opioid resulted in the highest odds of having a fall. These results suggest the importance of deprescribing and addressing opioid use in reducing the risk of having a fall in older PWH.

Reducing the harms of xylazine: clinical approaches, research deficits, and public health context.

OBJECTIVES: Xylazine has emerged as a consistent part of the unregulated drug supply in recent months. We discuss major domains of xylazine's harm, current knowledge deficits, clinical and harm reduction strategies for minimizing harm, and xylazine's public health and policy context. As an interdisciplinary team from across the USA, we have pooled our knowledge to provide an overview of xylazine's current and emerging contexts. METHODS: To inform this essay, the pertinent literature was reviewed, clinical knowledge and protocols were shared by multiple clinicians with direct expertise, and policy and public health context were added by expert authors. RESULTS: We describe xylazine's major harm domains-acute poisoning, extended sedation, and wounds, along with anemia and hyperglycemia, which have been reported anecdotally but lack as clear of a connection to xylazine. Current successful practices for xylazine wound care are detailed. Understanding xylazine's epidemiology will also require greater investment in drug checking and surveillance. Finally, approaches to community-based wound care are discussed, along with an orientation to the larger policy and public health context. CONCLUSIONS: Addressing the harms of xylazine requires interdisciplinary participation, investment in community-based harm reduction strategies, and improved drug supply surveillance. The relatively unique context of xylazine demands buy-in from public health professionals, harm reduction professionals, clinicians, basic science researchers, policymakers and more.

"We do it ourselves": strengths and opportunities for improving the practice of harm reduction.

BACKGROUND: Unprecedented increases in substance-related overdose fatalities have been observed in Texas and the U.S. since the onset of the COVID-19 pandemic and have made clear there is considerable need to reduce harms associated with drug use. At the federal level, initiatives have called for widespread dissemination and implementation of evidence-based harm reduction practices to reduce overdose deaths. Implementation of harm reduction strategies is challenging in Texas. There is a paucity of literature on understanding current harm reduction practices in Texas. As such, this qualitative study aims to understand harm reduction practices among people who use drugs (PWUD), harm reductionists, and emergency responders across four counties in Texas. This work would inform future efforts to scale and spread harm reduction in Texas. METHODS: Semi-structured qualitative interviews were conducted with N = 69 key stakeholders (25 harm reductionists; 24 PWUD; 20 emergency responders). Interviews were transcribed verbatim, coded for emergent themes, and analyzed using Applied Thematic Analysis with Nvivo 12. A community advisory board defined the research questions, reviewed the emergent themes, and assisted with interpretation of the data. RESULTS: Emergent themes highlighted barriers to harm reduction at micro and macro levels, from the individual experience of PWUD and harm reductionists to systemic issues in healthcare and the emergency medical response system. Specifically, (1) Texas has existing strengths in overdose prevention and response efforts on which to build, (2) PWUD are fearful of interacting with healthcare and 911 systems, (3) harm reductionists are in increasing need of support for reaching all PWUD communities, and (4) state-level policies may hinder widespread implementation and adoption of evidence-based harm reduction practices. CONCLUSIONS: Perspectives from harm reduction stakeholders highlighted existing strengths, avenues for improvement, and specific barriers that currently exist to harm reduction practices in Texas.

Predictors of PrEP retention in at risk patients seen at a HIV primary care clinic in San Diego.

BACKGROUND: Adherence to medication and retention in care are key contributors to the efficacy of pre-exposure prophylaxis (PrEP) for prevention of HIV. Therefore, it is important to understand factors that may impact retention in various settings that prescribe PrEP. METHODS: We evaluated factors associated with retention in care 3 and 12 months after PrEP initiation at a primary care HIV clinic in San Diego. Retention was defined as having an office/virtual visit within 1 month from the 3- or 12-months time point or interacting with the clinic leading to medication being refilled. RESULTS: A total of 199 patients were included. Retention rates were 74.4% and 52.8% at 3 and 12 months respectively. In the multivariate analysis, reporting depression or anxiety was associated with being retained in care (p = 0.004) and identifying as cisgender female was associated with lack of retention (p = 0.04) at 3 months. Testing positive for a sexually transmitted infection was associated with 12-months retention (p = 0.004); however, this was likely influenced by difference in the frequency of testing in those retained versus not retained. CONCLUSION: Ongoing efforts to determine the optimal method for provision of PrEP care that supports retention for different populations at risk for HIV, are needed.

Independent community pharmacists' attitudes and intentions toward dispensing buprenorphine/naloxone for opioid use disorder.

BACKGROUND: Buprenorphine/naloxone (BUP/NX) for opioid use disorder (OUD) is associated with positive health outcomes; however, challenges accessing prescribed BUP/NX at community pharmacies have been identified. OBJECTIVE: The theory of planned behavior was applied to determine whether independent community pharmacists' attitudes toward dispensing BUP/NX for OUD predict intentions to dispense. METHODS: A 40-item survey was administered to 185 Texas Community Pharmacy Enhanced Services Network pharmacists. The survey assessed intentions to dispense BUP/NX (3 items), attitudes toward BUP/NX (24 items), current barriers to dispensing BUP/NX (2 items), and demographics (10 items). Inferential statistics determined associations among pharmacists' attitudes, practice setting characteristics, and intentions to dispense BUP/NX. Regression analysis determined whether attitude predicted intention to dispense BUP/NX, controlling for practice setting and demographic characteristics. RESULTS: Responses were obtained from 82 community independent pharmacists (response rate = 44%). Respondents were predominantly non-Hispanic white (45.8%) and women (56.6%) and practiced in pharmacies with an average 1129.1 (± 1034.5) dispensed prescriptions/week. Pharmacists had positive intentions (6.2 ± 3.5) and attitudes (14.4 ± 24.9) toward dispensing BUP/NX and attitudes did not predict intentions to dispense (P = 0.330). Positive drivers of attitude were related to improving patient outcomes, fulfilling a community need, and absence of conflicts with pharmacists' personal and religious beliefs. A negative driver of attitude was financial reimbursement/loss. Pharmacists dispensing 2000 or more prescriptions/week had higher intentions (b = 3.22, P = 0.014) to dispense than those dispensing less than 500 prescriptions/week. The most common barrier to dispense BUP/NX was "refill was too soon" (54.8%). CONCLUSION: Community independent pharmacists had positive attitudes toward and intentions of dispensing BUP/NX for OUD. However, attitudes did not predict intentions to dispense. Negative drivers of attitudes were related to factors not within pharmacists' control, such as time to refill or financial reimbursement.Future studies focused on community pharmacy-based access to BUP/NX are warranted to elucidate issues that are impactful in improving pharmacists' dispensing intentions and behavior.

Addressing buprenorphine bottlenecks in the context of MAT Act implementation: A shared responsibility.

Medications for opioid use disorder (OUD) such as buprenorphine reduce overdose mortality and other opioid related acute health events but have historically been highly regulated. The recent Mainstreaming Addiction Treatment (MAT) Act ended the requirement clinicians complete a specified training and apply for a DATA 2000 ("X") waiver on their Drug Enforcement Administration (DEA) number, to prescribe buprenorphine. With the MAT Act, any practitioner with Schedule III prescribing authority (a regular DEA number) can now prescribe buprenorphine for OUD. While this has potential to improve OUD treatment access, the impact will depend on implementation. Though the MAT Act may facilitate increased buprenorphine prescribing, ensuring adequate buprenorphine dispensing is also critical to improving Medications for opioid use disorder. Recognized buprenorphine bottlenecks arise from a complex convergence of factors in community pharmacies, threatening to undercut the benefits of the MAT Act. If prescribing increases but is not matched by increased dispensing, bottlenecks may worsen. Any worsening of buprenorphine bottlenecks could have a disproportionate impact in rural areas where residents may rely on fewer pharmacies to fill prescriptions for people in larger geographic area and where larger prescribing-dispensing gaps already exist such as in Southern states. Rigorous research will be needed to document the overall impact of the MAT Act on community pharmacists and their patients. At the federal level, pharmacists and their professional organizations should lobby the DEA to de-schedule or re-schedule buprenorphine. The DEA should announce a moratorium on enforcement actions against wholesalers and pharmacies related to buprenorphine distribution and dispensing. More supports should be offered to community pharmacies by state pharmacy boards and associations including continuing pharmacy education and technical assistance for advocating with wholesalers to increase buprenorphine order sizes, and to more effectively communicate with prescribers. Pharmacies should not have to face these challenges alone. Regulators, wholesalers, and researchers must join together with community pharmacies to further reduce regulatory barriers to dispensing, provide evidence-based interventions where needed to support pharmacy dispensing efforts, conduct rigorous implementation research, and be constantly vigilant in identifying and addressing multi-level buprenorphine bottlenecks in the wake of the MAT Act.

Hepatitis C Virus Micro-elimination Among People With HIV in San Diego: Are We on Track?

Background: Rising incidence of hepatitis C virus (HCV) among people with HIV (PWH) in San Diego County (SDC) was reported. In 2018, the University of California San Diego (UCSD) launched a micro-elimination initiative among PWH, and in 2020 SDC launched an initiative to reduce HCV incidence by 80% across 2015-2030. We model the impact of observed treatment scale-up on HCV micro-elimination among PWH in SDC. Methods: A model of HCV transmission among people who inject drugs (PWID) and men who have sex with men (MSM) was calibrated to SDC. The model was additionally stratified by age, gender, and HIV status. The model was calibrated to HCV viremia prevalence among PWH in 2010, 2018, and 2021 (42.1%, 18.5%, and 8.5%, respectively), and HCV seroprevalence among PWID aged 18-39 years, MSM, and MSM with HIV in 2015. We simulate treatment among PWH, weighted by UCSD Owen Clinic (reaching 26% of HCV-infected PWH) and non-UCSD treatment, calibrated to achieve the observed HCV viremia prevalence. We simulated HCV incidence with observed and further treatment scale-up (+/- risk reductions) among PWH. Results: Observed treatment scale-up from 2018 to 2021 will reduce HCV incidence among PWH in SDC from a mean of 429 infections/year in 2015 to 159 infections/year in 2030. County-wide scale-up to the maximum treatment rate achieved at UCSD Owen Clinic (in 2021) will reduce incidence by 69%, missing the 80% incidence reduction target by 2030 unless accompanied by behavioral risk reductions. Conclusions: As SDC progresses toward HCV micro-elimination among PWH, a comprehensive treatment and risk reduction approach is necessary to reach 2030 targets.

Prescribing Syringes to People Who Inject Drugs: Advancing Harm Reduction in Primary Care.

Access to new syringes can reduce the risk of HIV and hepatitis C transmission, skin and soft tissue infections, and infectious endocarditis for people who inject drugs (PWID). Syringe service programs (SSPs) and other harm reduction programs are a good source of syringes. However, they are sometimes not accessible due to limited hours, geographic barriers, and other factors. In this perspective, we argue that when PWID faces barriers to syringes physicians and other providers should prescribe, and pharmacists should dispense, syringes to decrease health risks associated with syringe re-use. This strategy is endorsed by professional organizations and is legally permissible in most states. Such prescribing has numerous benefits, including insurance coverage of the cost of syringes and the sense of legitimacy conveyed by a prescription. We discuss these benefits as well as the legality of prescribing and dispensing syringes and address practical considerations such as type of syringe, quantity, and relevant diagnostic codes, if required. In the face of an unprecedented overdose crisis with many associated health harms, we also make the case for advocacy to change state and federal laws to make access to prescribed syringes uniform, smooth, and universal as part of a suite of harm reduction efforts.

The impact of the mainstreaming addiction treatment act and associated legislative action on pharmacy practice.

The recent passage of the Mainstreaming Addiction Treatment (MAT) Act will expand access to treatment for opioid use disorder (OUD) by eliminating prescriber registration requirements introduced as part of the Drug Abuse Treatment Act (DATA) of 2000. Without the X-Waiver, and Drug Enforcement Administration (DEA) registered prescriber can now prescribe buprenorphine. Eliminating DATA-2000 registration is the first step in improving access to buprenorphine, but additional barriers, including unclear restrictions on wholesale buprenorphine supply and insurance coverage, remain. Recently, the DEA formally clarified that suspicious order monitoring programs were managed entirely by wholesalers and manufacturers and that DEA does not set suspicious order monitoring limits. In this commentary, we address the somewhat conflicting implications of the MAT Act and recent DEA guidance on buprenorphine dispensing in community pharmacies. We also discuss innovative practice models that leverage pharmacists' cognitive skills to manage pharmacotherapy for persons with OUD. Recent policy changes and emerging evidence suggest that pharmacists are better positioned than ever to provide low-barrier access to treatment for OUD and to show their value in this practice area by actively engaging patients with prescribed buprenorphine.

Successful treatment of hepatitis C virus infection in patients on anti-epileptics or mood stabilizers using pharmacokinetic enhancers.

Co-administration of hepatitis C virus (HCV) direct-acting antivirals (DAAs) with anti-epileptics or mood stabilizers with cytochrome P450 (CYP) and/or drug transport-inducing properties is contraindicated due to concerns of subtherapeutic DAA levels that can lead to treatment failure and viral resistance. The recommended strategy is to change the interacting medication to a different agent that does not have inducing properties, but this is not always possible depending on the clinical scenario. We report on three patients who received DAAs for their HCV infection while remaining on the contraindicated anti-epileptic or mood stabilizer by utilizing CYP and drug transport inhibitors as pharmacokinetic enhancers to attempt to overcome the induction effects and maximize chances of achieving sustained virologic response (SVR). All patients achieved SVR despite the drug-drug interactions and there were no safety concerns. In patients facing this unique clinical quandary, the use of CYP and drug transport inhibitors appears to be a safe and possible strategy.

Single-center experience evaluating and initiating people with HIV on long-acting cabotegravir/rilpivirine.

OBJECTIVE: To describe our experience evaluating and initiating individuals on long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) and evaluate factors associated with starting LAI CAB/RPV and reasons for not starting. DESIGN: We conducted a retrospective single-center study at the UC San Diego Owen Clinic. METHODS: We included all individuals who expressed interest in treatment with LAI CAB/RPV between April 2021 and June 2022 who had a definitive decision made on starting LAI CAB/RPV. RESULTS: In total, 383 individuals were included with 201 (52.5%) initiating LAI CAB/RPV. Those who initiated LAI CAB/RPV were younger ( P  = 0.02) and were more likely to be on a two-drug regimen or first-generation integrase inhibitor regimen and less likely to be on a protease inhibitor or multiclass regimen. The most common reasons for not starting LAI CAB/RPV were inconsistent clinic attendance or difficulty being contacted and patient choice not to start. Of those who had a proviral DNA resistance test as workup for LAI CAB/RPV ( n  = 135), 18.5% had a resistance mutation identified that may have impacted the activity of LAI CAB/RPV. CONCLUSION: Despite novel challenges over half of our cohort initiated LAI CAB/RPV. Evaluating for potential non-nucleoside reverse transcriptase inhibitor resistance is an important part of the workup for LAI CAB/RPV and proviral DNA resistance testing can be an additional tool to identify potential resistance.