№ lp_1_2_47912
File format: docx
Character count: 6700
File size: 440 KB
Clinical protocol outlining eligibility, dosing, administration, monitoring, and care coordination requirements for the use of long-acting injectable cabotegravir and rilpivirine as an antiretroviral treatment regimen for adults with HIV-1 infection.
Year:
not specified
Language:
English
Topic:
HIV-1 treatment
Therapeutic regimen:
Long-acting injectable antiretroviral therapy
Medication:
Cabenuva (cabotegravir and rilpivirine)
Drug classes:
Integrase strand transfer inhibitor; non-nucleoside reverse transcriptase inhibitor
Route of administration:
Intramuscular gluteal injection
Dosing schedules:
Every 4 weeks; every 8 weeks
Target population:
Adults with HIV-1 infection
Eligibility criteria:
Virologically suppressed patients without relevant drug resistance
Exclusion criteria:
Pregnancy, breastfeeding, specific drug interactions, hypersensitivity
Monitoring requirements:
HIV viral load, CMP, CBC
Clinical setting:
Clinic-administered therapy
Healthcare roles:
Provider, case manager, registered nurse, pharmacy
Regulatory reference:
FDA labeling
Source adaptation:
Ward 86 Long-Acting Injectable ARV Protocol
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
United States
Topic:
Antiretroviral Therapy (ART)
Document Type:
Proposal
Institution:
MO HealthNet
Author:
MO HealthNet, Conduent
Target Audience:
Healthcare professionals, policymakers, and health program administrators
Effective Period:
2026–
Approval Date:
January 20, 2026
Revision Date:
April 7, 2022
Year:
2021
Region / City:
Global
Topic:
Pediatric HIV Treatment
Document Type:
Guideline
Organization:
World Health Organization (WHO)
Author:
World Health Organization (WHO)
Target Audience:
Healthcare workers, caregivers, HIV service providers, ministries of health
Period of Application:
Ongoing
Approval Date:
2021
Date of Changes:
Not specified
Year:
2017
Region / City:
KwaZulu-Natal, South Africa
Topic:
HIV prevention, Antiretroviral therapy, Young female-sex workers
Document Type:
Research report, Implementation study
Organization / Institution:
BMJ, StaRI Group
Author:
Pinnock H, Barwick M, Carpenter C, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A, Taylor SJC
Target Audience:
Researchers, Healthcare professionals, Public health practitioners
Period of validity:
Not specified
Approval date:
2017
Date of changes:
Not specified
Year:
2021
Region / city:
Johannesburg, Gauteng, RSA
Subject:
HIV drug resistance, antiretroviral therapy
Document type:
Research study
Institution:
South African National Health Laboratory Service, Toga laboratories (Pty) Ltd
Author:
Hermans LE, Nijhuis M, Tempelman HA, et al.
Target audience:
Researchers, healthcare professionals, policymakers
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Country:
Nigeria
City / Region:
Port Harcourt, Rivers State
Research Location:
Rivers State University Teaching Hospital (RSUTH); University of Port Harcourt Teaching Hospital (UPTH)
Subject Area:
Hematology; Hemostasis; HIV/AIDS Research
Type of Document:
Scientific Research Article
Study Population:
Human Immunodeficiency Virus-Positive subjects aged 20–79 years
Sample Size:
150 participants
Study Groups:
First-line regimen (Abacavir Lamivudine Dolutegravir); Second-line regimen (Tenofovir Lamivudine Dolutegravir); Naïve HIV-positive control group
Medical Conditions Studied:
Human Immunodeficiency Virus (HIV); hematologic abnormalities; haemostatic abnormalities
Laboratory Methods:
Sysmex XP-300 Automated Haematology Analyzer; Enzyme Linked Immunosorbent Assay (ELISA); Prothrombin Time (PT); Activated Partial Thromboplastin Time (APTT)
Statistical Analysis:
Student’s independent t-test; Analysis of Variance (ANOVA); Microsoft Office Excel 2007; GraphPad Prism 6.2
Measured Parameters:
White blood cell count; lymphocyte count; haemoglobin; neutrophil-to-lymphocyte ratio; prothrombin time; activated partial thromboplastin time; D-dimer levels
Study Objective:
Assessment of hematologic and haemostatic profiles in HIV-positive subjects receiving different antiretroviral regimens
Keywords:
Hematologic; Haemostatic; Human Immunodeficiency Virus-Positive Subjects; Antiretroviral regimen; First-line; Second-line; Naïve
Year:
2013–2015
Location:
Harare, Zimbabwe
Topic:
Pediatric HIV and respiratory health
Document type:
Research article
Institution:
Biomedical Research and Training Institute; Liverpool School of Tropical Medicine; London School of Hygiene and Tropical Medicine; University of Zimbabwe; University of Oxford
Authors:
Sarah Rylance, Jamie Rylance, Grace McHugh, Edith Majonga, Tsitsi Bandason, Hilda Mujuru, Kusum Nathoo, Sarah Rowland-Jones, Marc Y. R. Henrion, Victoria Simms, Rashida A. Ferrand
Funding:
Wellcome Trust, grant no 095878/Z/11Z
Target population:
Children and adolescents aged 6–16 years living with HIV
Study type:
Prospective cohort
Sample size:
468 participants
Follow-up period:
2 years
Data collection:
Spirometry, socio-demographic questionnaire, clinical history
Intervention:
Antiretroviral therapy initiation timing
Ethics approval:
Medical Research Council of Zimbabwe, Harare City Health Department Ethics Committee, London School of Hygiene and Tropical Medicine Ethics Committee, Biomedical Research and Training Institute Institutional Review Board
Type of document:
Pharmaceutical Benefits Advisory Committee (PBAC) submission and assessment report
Medicine:
Aripiprazole long-acting injectable (AOM)
Dosage forms/strengths:
Powder for injection 300 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe; Powder for injection 400 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe
Brand:
Abilify Maintena
Sponsor:
Lundbeck Australia Pty Ltd
Purpose of submission:
Request for General Schedule Authority Required (STREAMLINED) PBS listing of AOM pre-filled syringe dose form
Indication:
Treatment of schizophrenia
Comparator:
AOM modified release injection vial kit (therapeutic vial kits)
Regulatory status:
TGA registered 7 May 2018 for acute and maintenance treatment of schizophrenia in adults and maintenance treatment of bipolar I disorder (monotherapy)
Previous PBAC consideration:
400 mg AOM PFS recommended July 2018; recommendation rescinded March 2023
Pricing basis:
Cost-minimisation versus AOM vial kit with equivalent pricing (no price premium)
Price levels referenced:
DPMQ, PTP, AEMP (current as of 1 June 2025)
Estimated PBS usage:
400,000 to <500,000 scripts over first six years (Year 1 10,000–<20,000; Year 6 100,457)
Indication listing conditions:
Authority Required (Streamlined); prescriber types include medical practitioners and nurse practitioners; general schedule (Code GE)
Version number:
6.0
Approved by:
Medicines Committee
Ratified by:
Medicines Committee
Date ratified:
June 2023
Original author:
Luton & Bedfordshire Lead Pharmacist
Executive Director lead:
Chief Medical Officer
Implementation Date:
July 2023
Last Review Date:
June 2023
Next Review Date:
June 2026
Services:
Trustwide, Mental Health and LD, Community Health Services
Type of document:
Policy
Scope:
Long-acting antipsychotic injections, typical and atypical
Target audience:
Clinicians, pharmacists, mental health services staff
Document structure:
Includes guidance on initiation, choice, and monitoring of depot injections, adverse effect reporting, and appendices with forms and rating scales
Year:
2010
Region / City:
Connecticut
Subject:
Pharmaceutical practice, Collaborative practice agreements, Antipsychotic therapy
Document Type:
Legal agreement, Clinical protocol
Organization / Institution:
Connecticut Department of Consumer Protection, University of Connecticut School of Pharmacy
Author:
C. Caley, PharmD, BCPP, Clinical Professor
Target Audience:
Pharmacists, Physicians, Healthcare providers in Connecticut
Effective Date:
October 1, 2010
Date of Approval:
Not specified
Date of Review:
Annual review completed
Date of Modification:
Not specified
Document type:
Shared care protocol
Medicine:
Paliperidone palmitate long-acting injection
Indication:
Maintenance treatment of schizophrenia
Population:
Adults aged 18 years and over
Healthcare setting:
Secondary and primary care
Intended users:
NHS healthcare professionals
Initiation of treatment:
Secondary care mental health services
Shared care commencement:
After approximately 12 weeks when dose is optimised
Dosage forms:
1-monthly, 3-monthly and 6-monthly long-acting injections
Renal impairment restriction:
Not recommended in moderate or severe renal impairment (creatinine clearance <50 ml/min)
Version:
v4.0
Replaces version:
v3.0
Clinical content last reviewed:
January 2024
Next review date:
June 2026
Approving bodies:
GM CRG, GMMMG, CEGC
Approval dates:
14 May 2024; 13 June 2024; 20 June 2024
Geographical scope:
NHS Greater Manchester
Usage restriction:
Non-commercial, non-marketing use only
Year:
2021
Region / City:
United States
Subject:
Medicine, Pharmacology
Document Type:
Drug Information
Agency / Institution:
Food and Drug Administration (FDA)
Author:
FDA
Target Audience:
Healthcare professionals, physicians, pharmacists
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Revisions:
Not specified
Year:
2023
Region / City:
Global
Topic:
Pharmacology, Psychiatry
Document Type:
Medical Guidelines
Organization / Institution:
Unspecified
Author:
Unspecified
Target Audience:
Healthcare Professionals, Psychiatrists
Duration of Validity:
Indefinite
Approval Date:
Unspecified
Date of Changes:
Unspecified
Year:
2024
Region:
Massachusetts, USA
Subject:
Healthcare billing, Antipsychotic medications
Document Type:
Policy / Instruction
Organization:
MassHealth
Audience:
In-state acute inpatient hospital providers
Effective Date:
5/15/2024
Reference:
Sections 5.B.4.g of the MassHealth Acute Hospital Request for Applications
Medication Covered:
Long-Acting Injectable (LAI) Antipsychotics
Billing Codes:
National Drug Code (NDC), HCPCS
Submission Requirements:
Professional claims (Claim Types M and B), Direct Data Entry for IC drugs, invoice attachment from distributor/manufacturer
Payment Methodology:
Fee schedule in 101 CMR 317.00 or Individual Consideration (IC)
Documentation:
Attachments via Provider Online Service Center (POSC)
Compliance Notes:
Failure to follow instructions may result in inaccurate payment
Instruction Updates:
May be updated from time to time
Year:
2024
Region / City:
Massachusetts
Topic:
Long-Acting Injectable Antipsychotic Medications
Document Type:
MassHealth Drug List Update
Institution:
MassHealth
Author:
MassHealth
Target Audience:
Healthcare providers, inpatient psychiatric service providers
Effective Period:
May 15, 2024
Approval Date:
May 15, 2024
Update Date:
Ongoing updates
Applicable Policy:
Long-Acting Injectable Antipsychotic Medication Payment and Reimbursement Policy
J-Codes:
J0401, J0402, J1631, J1943, J1944, J2358, J2426, J2427, J2428, J2680, J2794, J2798, J2799, J2801
Billing Instructions:
Available on the MassHealth website