Implementing Long-Acting Antiretroviral therapy in Clinic Sharing Our Experience

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IMPLEMENTING LONG-ACTING ANTIRETROVIRAL THERAPY IN CLINIC: SHARING OUR EXPERIENCE Midwest AIDS Training + Education Center of Kansas and Nebraska (MATEC-KS/NE) Omaha HIV Program Omaha, Nebraska June 22, 2021 1 Disclaimer "This program is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $3,994,961 with 0 percentage financed with nongovernmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government." 2 Disclosures Speakers: Susan Swindells, MBBS Receives research grants from ViiV Healthcare paid to the University of Nebraska Medical Center Christine D. Tran, DNP, APRN No disclosures Josh Havens, PharmD Received research grant from Gilead Sciences, Inc. paid to the University of Nebraska Medical Center Maureen Kubat, RN No disclosures Planners Sara Bares, MD Received research grants to the University of Nebraska Medical Center from Gilead Sciences, ViiV Healthcare, and Jannsen Nikki Regan, APRN, Deanna Hansen, Susan Tusher, LMSW have no disclosures 3 Learning Objectives Recall processes and data from long-acting antiretroviral clinical trials Discuss why patients may desire long-acting antiretroviral therapy Identify patients who are best candidates for long-acting antiretroviral therapy in commercial use Discuss cost and process for obtaining access to long-acting antiretroviral therapy through a variety of medical and pharmacy benefit programs Begin to formulate an implementation process for long-acting antiretroviral therapy for patients in our clinics 4 BACKGROUND:Clinical Trial Review and What Patients Want Susan Swindells, MBBS Professor of Medicine University of Nebraska Medical Center 5 How to define "long-acting"? Route of delivery Oral Parenteral Implant / Device Dosing frequency 1 week 1month 6months Owen and Rannard. ADDR. 2016 Technology for Drug Delivery Long-acting depot injections Subdermal implant Vaginal rings Microneedle drug patch Wearable infusion pump Novel oral formulations Thanks to Kim Scarsi 7 Long-Acting Antiretroviral Therapy:Potential Opportunities and Challenges OPPORTUNITIES Less frequent dosing Avoidance of "pill fatigue" Oral dosing by-passed; bioavailability ~100% Less adverse events Less drug-drug interactions Protection of health privacy Avoidance of HIV-related stigma Improved adherence? CHALLENGES Large injection volumes Need for oral lead in Management of missed doses Coverage of the "tail" Development of drug resistance Management of drug-drug interactions Management of serious adverse events Unknown dosing for children & pregnant women LA ARVs in Development or Clinical Use 9 ARV Class Agent Formulation Development Stage NRTI MK-8591 Implant Preclinical TAF Implant Preclinical (Px) GS-9131 Implant Preclinical NNRTI Rilpivirine Injectable Phase III/NDA Elsulfavirine Injectable Preclinical PI Atazanavir Injectable Preclinical Ritonavir Injectable Preclinical INSTI Cabotegravir Injectable Phase III/NDA, Phase II/III (Px) Raltegravir Injectable Preclinical Entry Inhibitors Ibalizumab Intravenous FDA Approved (Tx) PRO 140 Intravenous and Injectable Phase III Albuvirtide Intravenous and injectable Approved in China bNAbs (e.g., VRC01) Intravenous Phase II/III Combinectin Intravenous Preclinical Capsid Inhibitors GS-CA1 Injectable Preclinical 9 PHASE 3 ATLAS & FLAIR DESIGNS ATLAS Virologic Snapshot Outcomes at Week 48 for ITT-E: Noninferiority Achieved for Primary and Secondary Endpoints Primary endpoint: LA noninferior to CAR (HIV-1 RNA 50 c/mL) at Week48 Difference (%) -1.2 2.5 0.6 CAR CAB LA + RPV LA 6% NImargin Virologic Outcomes Adjusted Treatment Difference (95% CI)* CAB, cabotegravir; CAR, current antiretroviral; CI, confidence interval; ITT-E, intention-to-treat exposed; LA, long-acting; NI, noninferiority; RPV, rilpivirine. *Adjusted for sex and baseline third agent class. Virologic nonresponse (50 c/mL) Swindells NEJM 2020 11 ATLAS Virologic Snapshot Outcomes at Week 48 for ITT-E: Noninferiority Achieved for Primary and Secondary Endpoints Virologic Outcomes Adjusted Treatment Difference (95% CI)* Virologic nonresponse (50 c/mL) Virologic success (<50 c/mL) No virologic data CAB, cabotegravir; CAR, current antiretroviral; CI, confidence interval; ITT-E, intention-to-treat exposed; LA, long-acting; NI, noninferiority; RPV, rilpivirine. *Adjusted for sex and baseline third agent class. Primary endpoint: LA noninferior to CAR (HIV-1 RNA 50 c/mL) at Week48 Difference (%) -1.2 2.5 0.6 CAR CAB LA + RPV LA 6% NImargin Key secondary endpoint: LA noninferior to CAR (HIV-1 RNA <50 c/mL) at Week48 Difference (%) -6.7 0.7 -3.0 CAR CAB LA + RPV LA 10% NI margin Swindells NEJM 2020 Slide 13 of 37 12 FLAIR Virologic Snapshot Outcomes at Week 48 for ITT-E:Noninferiority Achieved for Primary and Secondary Endpoints Virologic outcomes Primary endpoint: LA noninferior to DTG/ABC/3TC (50 c/mL) at Week48 Difference (%) 2.8 2.1 0.4 DTG/ABC/3TC CAB LA + RPV LA Adjusted treatment difference (95% CI)* 6% NImargin Virologic nonresponse (50 c/mL) 3TC, lamivudine; ABC, abacavir; CAB, cabotegravir; CI, confidence interval; DTG, dolutegravir; ITT-E, intention-to-treat exposed; LA, long-acting; NI, noninferiority; RPV, rilpivirine. *Adjusted for sex and baseline HIV-1 RNA (< vs 100,000 c/mL). Orkin NEJM 2020 13 FLAIR Virologic Snapshot Outcomes at Week 48 for ITT-E:Noninferiority Achieved for Primary and Secondary Endpoints Orkin C, NEJM 2020. 3TC, lamivudine; ABC, abacavir; CAB, cabotegravir; CI, confidence interval; DTG, dolutegravir; ITT-E, intention-to-treat exposed; LA, long-acting; NI, noninferiority; RPV, rilpivirine. *Adjusted for sex and baseline HIV-1 RNA (< vs 100,000 c/mL). Virologic outcomes Primary endpoint: LA noninferior to DTG/ABC/3TC (50 c/mL) at Week48 Difference (%) 2.8 2.1 0.4 DTG/ABC/3TC CAB LA + RPV LA Adjusted treatment difference (95% CI)* 6% NImargin Key secondary endpoint: LA noninferior to DTG/ABC/3TC (<50 c/mL) at Week48 Difference (%) CAB LA + RPV LA 3.7 4.5 0.4 DTG/ABC/3TC 10% NI margin Virologic nonresponse (50 c/mL) Virologic success (<50 c/mL) No virologic data 14 Confirmed Virologic Failure With Resistance: CAB LA + RPV LA Arm 15 Rizzardini JAIDS 2020 Plasma CAB and RPV concentrations at the time of failure were below the population means but within the range for the large majority of individuals who maintained virologic suppression Univariate analysis of CVF outcome by 10 pre-specified factors including ATLAS, FLAIR & ATLAS 2M Cutrell AIDS 2021 Presence of 2 factors associated with increased CVF risk: proviral RPV RAMs, HIV-1 subtype A6/A1, and/or BMI 30 kg/m2. ATLAS & FLAIR COMBINED SAFETY RESULTS Rizzardini JAIDS 2020 Mean (SD) weight change at week 48 from baseline was an increase of 2.34 kg (5.67) and 1.17 kg (5.22) in the LA and CAR arms, respectively. ATLAS & FLAIR COMBINED DATA CAB + RPV LA Every 8 Weeks Remains Noninferior to Every 4 Weeks at Week 96 in ATLAS 2M Jaeger CROI 2021 Summary Of CVF Events Jaeger CROI 2021 Do Our Patients Want ART by Injection? Williams et al Nanomedicine 2012 400 patients 68% male 53% AA Mean age 47 ATLAS & FLAIR COMBINED DATA LA/ER formulations: What can we learn from other disease areas? WHAT CAN WE LEARN FROM PrEP STUDIES? Cabotegravir PrEP Studies in MSM/TGW and CGW Cisgender men and transgender women who have sex with men Non-inferiority, double-blind, double-dummy design N=4566 at 43 sites in Argentina, Brazil, Peru, South Africa, Thailand, United States, Vietnam Protocol Chairs: Raphael Landovitz and Beatriz Grinsztejn 27 Cisgender women Superiority, double blind, double dummy design N=3224 at 20 sites in Kenya, Malawi, South Africa, Swaziland, Uganda, Zimbabwe Protocol Chairs: Sinead Delaney-Moretlwe and Mina Hosseinipour Slide 24 of 37 27 HIV Incidence ITT 2247 2243 2133 2138 2081 2092 2019 2032 1913 1921 1764 1776 1624 1632 1494 1488 1294 1312 1132 1119 965 957 816 795 643 644 516 503 400 401 310 318 230 243 149 172 85 111 33 42 0 0 0 0 0 0 0 0 0 0 0 0 1 3 6 4 8 5 12 6 14 8 22 9 25 11 27 11 29 11 30 12 32 12 33 12 35 12 35 13 36 13 36 13 37 13 38 13 39 13 0 0 0 0 0 0 0 0 0 0 0 9 17 25 33 41 49 57 65 73 81 89 97 105 113 121 129 137 145 153 161 169 177 185 193 0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 Cumulative Incidence TDF/FTC Cabotegravir HR 0.34 (0.18, 0.62) p=0.0005 Weeks since enrollment Number at risk TDF/FTC Cabotegravir TDF/FTC Cabotegravir Cumulative number of events - Landovitz RJ et al. AIDS 2020, #OAXLB0101 1 year 2 years 3 years 66% reduction in incidence with CAB vs TDF/FTC Clear demonstration of the benefits of an LA formulation as compared to standard one-pill-once-per-day 28 Cumulative HIV incidence ITT Women in the CAB group had an 89% lower risk of HIV infection, compared to TDF/FTC group Delany-Moretlwe, HIV R4P 27 Jan 2021, LB1479 CAB-LA superior to daily oral TDF/FTC in HPTN 084 Cabotegravir PrEP Study in Cis-gender Women 29 Schizophrenia -- adherence Osteoporosis -- convenience Contraception -- choice Prostate cancer all 3! Why LA/ER antiretrovirals may play a major role in the future of HIV treatment and prevention The majority of patients with schizophrenia relapse after 5 years and poor adherence is the most common cause. The discontinuation rate for oral antipsychotics is 26%-44%. Up to a third of patients are at least partially non-adherent. Non-adherence is associated with increased relapse, hospitalization and suicide. Long-acting injectable treatment is associated with lower rates of relapse, discontinuation and hospitalization versus oral anti-psychotics, and increased cost-effectiveness, functionality, quality of life and patient satisfaction. Use of LAIs in Chronic Schizophrenia - Kaplan et al., Patient Preference and Adherence; 2013 Thanks to Charles Flexner Adherence to oral bisphosphonates for the treatment of osteoporosis is low. At least one-third of patients do not consistently take oral bisphosphonates as prescribed. Rates of adherence to oral tablets decrease over time. Patients overwhelmingly prefer a once-yearly injectable product (IV zoledronic acid). Use of LAIs in Osteoporosis - Fobelo Lozano et al., Eur J Hosp Pharm; 2017 Adherence to long-acting therapies: Lessons from contraception Perfect vs. Typical Use Winner et al. NEJM 2012; 366:1998-2007 Prospective cohort of 7486 participants over 3 years Implants Injections Other hormonal methods* * Pill, patch, vaginal ring Thanks to Kim Scarsi we identified 334 unintended pregnancies. The contraceptive failure rate among participants using pills, patch, or ring was 4.55 per 100 participant-years, as compared with 0.27 among participants using long-acting reversible contraception (hazard ratio after adjustment for age, educational level, and history with respect to unintended pregnancy, 21.8; 95% confidence interval, 13.7 to 34.9). Bars depict the cumulative percentage of participants who had a contraceptive failure with long-acting reversible contraception (LARC), depot medroxyprogesterone acetate (DMPA), or pill, patch, or ring (PPR) at 1, 2, or 3 years. Participants using PPR had significantly more unintended pregnancies than those using LARC (P<0.001) or DMPA (P<0.001). 34 Implementation will Be Challenging Thank you to Andrea Mantsios 35 SUMMARY More choices for patients and providers All treatment trials so far only include pts with optimal adherence Randomized treatment trial data for those with adherence challenges will not be available for some [A5359/LATITUDE] Risk factors for virologic failure are different Some failures with resistance may occur despite "good adherence" Providers and patients will need to consider options carefully Clinics will need to adjust workflow/address logistics REMEMBER THIS IS FIRST IN CLASS Patient Eligibility and Education Christine D. Tran, DNP, APRN Nurse Practitioner, Infectious Disease Nebraska Medicine 39 PREPARATION Creating our Clinical Protocol Eligibility Criteria Dosing Considerations Patient Education 40 Prescribing Information 41 https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF DHHS Guidelines Panel Recommendations https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/hhs-adults-and-adolescents-antiretroviral-guidelines-panel Eligibility Criteria Able to come to clinic for injections every month Virologically suppressed (HIV-1 RNA < 50 copies/mL) for 3 months On stable ART regimen for the last 6 months No major known INSTI or NNRTI resistance-associated mutation except for K103N No prior hypersensitivity reaction to cabotegravir, rilpivirine (or other integrase inhibitors: bictegravir, dolutegravir) Not currently receiving any of the following medications: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone, or St John's wort Not co-infected with hepatitis B Not currently pregnant or planning to conceive in near future (insufficient data) Dosing Considerations Transitioning to long-acting injectables Recommend patient and/or clinic select a monthly injection date prior to first injection as it helps to have a consistent monthly injection date Pick a day between the 1st and 28th of the month Month 1 (at least 28 days): Oral lead-in Month 2 (one-time dosing): Initiation injections Month 3 (and beyond): Continuation injections Dosing flexibility Missed injections 44 Transitioning Dosing https://assets.gskstatic.com/pharma/us/viiv/Cabenuva-Dosing-Administration-Guide.pdf Dosing Flexibility Injections can be given up to 7 days before or 7 days after the targeted treatment date If patients receive injections within 7 days before/after their targeted treatment date, the following monthly dose should be scheduled for the original monthly injection date If patient plans to miss a scheduled injection visit by > 7 days, prescribe oral therapy with cabotegravir/rilpivirine to replace up to 2 consecutive monthly injection visits Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate Missed injection 47 https://assets.gskstatic.com/pharma/us/viiv/Cabenuva-Dosing-Administrati... Planned Missed Injection First dose of oral therapy (cabotegravir 30 mg + rilpivirine 25 mg) should be taken approximately 1 month after the last injection dose of cabotegravir/rilpivirine Continue oral therapy daily until the day injection dosing is restarted If oral treatment will continue for > 2 months, an alternative fully suppressive regimen should be chosen based on treatment history and availability of resistance testing results 48 Planned Missed Injection 49 https://assets.gskstatic.com/pharma/us/viiv/Cabenuva-Dosing-Administrati... Patient Education Review clinical protocol with patient Provide verbal and written information Review what to expect with injections Provide injection overview - process, side effects, length of visits Preferred position for administration - lying down Allow time for patient to ask questions Offer "Patient Liaison" Experienced patient willing to talk to potential patients Complete "Patient Agreement" Effort and commitment, on behalf of the medication recipient and the clinic staff, in order to be successful Capture contact information 50 51 Accessing Medication Josh Havens, PharmD, BCPS Clinical Pharmacist, HIV Program Assistant Clinical Professor, College of Pharmacy University of Nebraska Medical Center 52 Additional Learning Objective Understand the enrollment, procurement, and billing processes for commercially available long-acting injectable antiretroviral therapy, Cabenuva (CAB/RPV) 53 Full Process Enrollment Coverage Determination Prior Authorization Access Options Secondary Coverage Options 54 EnrollmentForm 55 ViiV Connect Website (https://www.viivconnect.com/content/dam/cf-viiv/viiv-connect/master/pdf/...) EnrollmentForm 56 ViiV Connect Website (https://www.viivconnect.com/content/dam/cf-viiv/viiv-connect/master/pdf/...) Coverage Determination/Prior Authorization 57 ViiV Connect reviews coverage and provides clinic with options for prescription and acquisition. Access Options Buy-and-Bill White Bagging Brown Bagging Description Clinic acquires and bills for drug and administration Prescription sent to specialty pharmacy; drug mailed to clinic for administration Prescription sent to specialty pharmacy; patient picks it up and takes to provider for administration Medical Benefit X X Pharmacy Benefit X X Administration Fee X X X Clinic Inventory Control X X Comments CAB/RPV requires cold-chain storage. Thus, the "brown bag" option is unlikely to be an option for access. Medical claims subject to deductible/out-of-pocket for administration fees Wholesaler limited distribution for buy-and-bill (Cardinal, ASD, Besse, Curascript, McKesson) 58 Adapted from Cabenuva Website: https://www.viivconnect.com/content/dam/cf-viiv/viiv-connect/master/pdf/... Cost Loading Dose (600/900mg) Maintenance Dose (400/600mg) Average Wholesale Price (AWP) $7,200 $4,800 Wholesaler Acquisition Cost (WAC) $5,900 $3,960 340B Acquisition Cost $4,567 $3,045 ADAP Acquisition Cost $1,800 $1,200 Comments All estimated prices1; ADAP price estimated to be 25% of AWP 59 1AWP/WAC estimated pricing provided by NASTAD; 340B received from Cardinal Health Uninsured Patient Assistance Live in the United States Income <500% of the Federal Poverty Level (1 person - $64,400, 2 person - $87,100, 3 person $109,800) Not eligible for Medicaid AND Have no prescription coverage OR Have Medicare Part B, D, or Advantage Plan and spent at least $600 out of pocket 60 Adapted from ViiV Connect Website: https://www.viivconnect.com/injectable/patient-assistance-program Secondary Coverage Options ViiV Copay Assistance $13,000 of annual assistance with out-of-pocket drug costs Does not cover physician office visit or administration fees Primary coverage must not be government funded (Medicare, Medicaid, VA, or Tricare) Access up-front or as rebate Up-front if specialty pharmacy route billing information provided to pharmacy by ViiV Connect Rebate patient fills out rebate form and supplies supporting documentation 61 Adapted from ViiV Connect Website: https://www.viivconnect.com/injectable/patient-savings-program Secondary Coverage Options ADAP Subject to respective state formulary and billing preferences Billing Drug billed to ADAP pharmacy benefit manager Physician/Admin Fees invoiced to state ADAP program as an Outpatient/Ambulatory Health Service category Grant Foundations primarily for Medicare D members Patient Advocate Foundation1 Good Days: Chronic Disease Fund2 62 1Accessed at https://www.patientadvocate.org/connect-with-services/copay-relief/ 2Accessed at https://mygooddays.org Bridge Program Coverage for commercially insured patients waiting on CAB/RPV formulary placement No coverage for government funded, uninsured, or commercially insured (when coverage is excluded) patients Program length of 12 months Enrollment Complete enrollment form ViiV Connect will contact provider and coordinate shipment if patient wants to proceed Does not cover physician/administration fees 63 Adapted from: https://www.viivconnect.com/content/dam/cf-viiv/viiv-connect/master/pdf/CABENUVA_Bridge_Program_Brochure.pdf Resources https://www.viivconnect.com/content/dam/cf-viiv/viiv-connect/master/pdf/CABENUVA_Enrollment_Form.pdf https://www.viivconnect.com/injectable/resources/ 64 Administration Considerations, Side Effect Management &Optimization of Adherence Maureen Kubat, BSN, RN Clinical Research Coordinator University of Nebraska Medical Center 65 Medication Supply Considerations Oral Lead-In dosing shipped directly to patient or provider Oral cabotegravir not available at retail pharmacies One tablet of each, once daily Schedule first injection on day 28-30 Patient ideally takes last oral dose on the day of Initiation injections IMPORTANT: plan with patient to ensure success 66 https://cabenuvahcp.com/dosing-and-drug-interactions/ Medication Supply Considerations Initiation Injection Kits Continuation Injection Kits 67 Single-dose vials of cabotegravir-LA 600mg/3mL and rilpivirine-LA 900mg/3mL 2 syringes, 2 labels, 2 vial adapters, 2 needles (23-gauge, 1 inch) Single-dose vials of cabotegravir-LA 400mg/2mL and rilpivirine-LA 600mg/2mL 2 syringes, 2 labels, 2 vial adapters, 2 needles (23-gauge, 1 inch) https://cabenuvahcp.com/dosing-and-drug-interactions/ Medication Supply Considerations Kits will arrive via cold-chain supply Store in refrigerator at 2-8 (36-46 ) in original carton until ready for use Once removed from refrigerator, medication must be used within 6 hours Cannot be cycled in and out of refrigerator Once drawn up for injection, must be used within 2 hours Kit dimension: 6.2" x 5.6" x 1.7" 68 Pre-Initiation Injection Considerations 69 Clinic Considerations Patient Considerations Space: Room with exam table Staffing and Clinic Flow 15 minutes for medication to warm to room temperature 5 minutes for injection preparation 5 minutes for injection administration 10-15 minutes patient observation Universal site selection for cabotegravir LA vs. rilpivirine LA Education Patient-friendly schedule Body habitus Consider 2" needles* for: BMI >30 kg/m2 Increased fat distribution in hips & buttocks Assess for scar tissue, tattoos, nodules from previous injections, presence of gluteal implants at injection sites. * 2" 21-gauge safety needles are not included in kits and need to be separately ordered https://cabenuvahcp.com/injection-education/ Administration Considerations: Medication Preparation 70 Remove kit from fridge and allow to warm to room temperature for 15 minutes Label each syringe with patient and medication information, including the time medications are drawn into syringes Medications can be in syringes for up to 2 hours before discard is required Shake each medication vigorously to evenly distribute contentsno reconstitution is needed Draw up cabotegravir-LA and rilpivirine-LA, each into a separate syringe, using adaptors in the kits Do not combine medications Attach needles to syringes https://cabenuvahcp.com/injection-education Administration Considerations: Patient Preparation Goal= Ease anxiety Not necessary to change out of clothing Maximize patient autonomy Sequence of injections Rilpivirine-LA is thicker, Cabotegravir-LA is thinner Timing of injections Positioning as appropriate Employ relaxation techniques Distraction Deep-breathing Music Have patient lay on exam table Promotes safety and relaxation 71 Administration of Medications Ventrogluteal Site Dorsogluteal Site 72 Don gloves and isolate the muscle at the site of the injection Preferably have the patient lay on the exam table, on side, with hip facing up Note: each medication should be given into a separate site, on opposite sides, or at least 2 cm apart Have patient flex isolated muscle and feel for muscle movement to ensure placement https://cabenuvahcp.com/injection-education/ Administration of Medications Have patient relax completely Clean isolated area with alcohol wipe Use the Z-track technique to minimize medication leakage from the injection site Firmly drag the skin covering the injection site, displacing it by about an inch Keep it held in this position for the duration of the injection Slowly and steadily inject the medication to avoid excessive pressure Withdraw the needle and release the stretched skin immediately Apply pressure and bandage Monitor patient for 10-15 minutes after first injection 73 https://cabenuvahcp.com/injection-education Z-track technique What to Expect from Injections During injections, patients may experience: Pain/discomfort most common Muscle spasm Sensation of "feeling the medication going in" Sensation of medication dripping down the leg 74 Side Effects Injection Site Reactions Systemic Side Effects Pain or soreness at the site most common ISR 1st injections generally the most painful Nodules Itching Swelling Bruising Muscle spasm Headache Fatigue Nausea Dizziness Fever Rash Encourage patient to call should evaluate 75 https://cabenuvahcp.com/dosing-and-drug-interactions Managing Side Effects Heat/cold Ibuprofen/acetaminophen Before and/or after injections Encourage movement, but not overexertion Plan activities accordingly Anticipatory guidance goes a long way! 76 Scheduling Injections Pick target date of the month between 1st 28th Injection window will be the 14 days around that (+/- 7 days on either side) 77 https://cabenuvahcp.com/content/dam/cf-viiv/cabenuva-hcp/master/pages/do... cabotegravir and rilpivirine Scheduling Considerations Clinic Patient Exceptions Staffing Space Work School Personal Travel Walk-ins Triaging patient concerns/issues unrelated to injections 78 Missed Injections - Unplanned If >7 days but 7 days and > 2 months since last injections, restart with initiation dose injections; then resume standard monthly dosing 79 Time Since Last Injection Recommendation <2 months Resume with 400-mg (2-mL) cabotegravir and 600-mg (2-mL) rilpivirine IM monthly injections as soon as possible >2 months Re-initiate the patient with 600-mg (3-mL) cabotegravir and 900-mg (3-mL) rilpivirine IM injections, then continue to follow the 400-mg (2-mL) cabotegravir and 600-mg (2-mL) rilpivirine IM monthly injection dosing schedule CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021 Missed Injections - Planned 80 Oral bridging Oral cabotegravir available through ViiV Oral rilpivirine can be prescribed at pharmacy First dose taken approximately 1 month after last injections Continue until the day of the next injections If oral ART will continue for > 2 months, consider an alternate regimen based on patient history CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021 Retention strategies ** Patients who may benefit the most from LA therapy may also be at highest risk for non-adherence 81 81 Retention strategies 82 Reminder calls and/or texts prior to visit Immediate call if appointment is missed Scheduling patients at risk for non-adherence on the early side of the window to allow for rescheduling within window if appointment is missed Obtain multiple ways to contact patient Phone number(s) text, voicemail Email EMR patient portal/messaging Obtain friends/family contact info Verify contact info at each visit Retention strategies 83 Consider patient "contract" or agreement Explains expectations for both clinic and patient Consider transportation support Retention coordinator Point person for managing retention efforts Software/flowsheet to track appointments Resources https://cabenuvahcp.com 84 QUESTIONS?GROUP DISCUSSION 85 86 Contact Information MATEC-Kansas/Nebraska Clinical Team Donna Sweet, MD, AAHIVS, MACP - Clinical Director [email protected] Susan Tusher, LMSW - Program Director [email protected] Sara Bares, MD - Associate Professor, Infectious Diseases, UNMC [email protected] Nikki Regan, MSN, APRN, NP-C Omaha HIV Program Coordinator [email protected] 87