First injectable HIV treatment regimen approved
The US Food and Drug Administration and the European Medicines Agency have both approved the first extended-release, injectable, standalone treatment for adults with HIV infection. The cabotegravir and rilpivirine injectable regimen is approved for those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure, and with no known or suspected resistance to either drug.
The safety and efficacy of the combination regimen was established through two randomised, open-label, controlled clinical trials in 1182 HIV-infected adults who were virologically suppressed (HIV-1 RNA <50 copies/mL) before initiation of treatment. Patients continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.
The US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents recommends that cabotegravir and rilpivirine injection can be used as an optimisation strategy for people with HIV currently on oral antiretroviral therapy with documented viral suppression for at least 3 months who meet certain criteria.[59]
The treatment is given by intramuscular injection every 4 weeks. Oral formulations of the two drugs must be taken for one month before starting treatment to ensure the injectable formulation is well tolerated.
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Summary
Definition
History and exam
Key diagnostic factors
- presence of risk factors
- fevers and night sweats
- weight loss
- skin rashes and post-inflammatory scars
- oral ulcers, angular cheilitis, oral thrush, or oral hairy leukoplakia
- diarrhoea
- wasting syndrome
- changes in mental status or neuropsychiatric function
- recent hospital admissions
- tuberculosis (TB)
- medical comorbidities
- sexual activity
- generalised lymphadenopathy
- Kaposi's sarcoma
- genital STIs
- chronic vaginal candidiasis
- shingles
- headaches
- periodontal disease
- retinal lesions on fundoscopy
- shortness of breath on exertion, cyanosis on exertion, dry cough, silent chest on auscultation
Other diagnostic factors
- current and prior use of other substances
- peripheral neuropathy
- recurrent herpes simplex
- hepatomegaly or splenomegaly
- meningeal signs (bacterial or viral meningitis)
Risk factors
- needle sharing with intravenous drug use
- unprotected receptive anal intercourse
- unprotected receptive penile-vaginal sexual intercourse
- percutaneous needle stick injury
- high maternal viral load (mother to child transmission)
- use of progestin-only injectable contraceptives
- herpes simplex virus type 2 (HSV-2) infection
Diagnostic investigations
1st investigations to order
- serum HIV enzyme-linked immunosorbent assay (ELISA)
- serum HIV rapid test
- HIV non-invasive tests
- serum Western blot
- serum p24 antigen
- serum HIV DNA polymerase chain reaction (PCR)
- CD4 count
- serum viral load (HIV RNA)
- drug resistance testing
- pregnancy test
- serum hepatitis B serology
- serum hepatitis C serology
- serum venereal disease research laboratory test
- Treponema pallidum haemagglutination test
- rapid plasma reagin
- tuberculin skin test
- FBC with differential
- serum electrolytes
- serum creatinine
- urinalysis
Investigations to consider
- chest x-ray
- liver function tests (LFTs)
- random or fasting lipid profile
- random or fasting plasma glucose
- hepatitis A serology (IgG)
- toxoplasma serology (IgG)
- gonorrhoea and chlamydia testing
- human leukocyte antigen-B*5701 testing
Treatment algorithm
Contributors
Authors
Chad J. Achenbach, MD, MPH
Assistant Professor of Medicine
Infectious Diseases
Northwestern Medicine
Feinberg School of Medicine, Northwestern University
Chicago
IL
Disclosures
CJA is a consultant on an educational programme on HIV and ageing with ViiV, has received speaker fees for talks on HIV and ageing with ViiV, and has received a grant for investigator sponsored research from Gilead Sciences. CJA has been paid for service on a Data Safety Monitoring Board by ABIVAX.
Acknowledgements
Dr Chad J. Achenbach would like to gratefully acknowledge Dr Richard Rothman, Dr Michael Ehmann, Dr Linda-Gail Bekker, Dr Catherine Orrell, and Dr Lisa Capaldini, the previous contributors to this topic.
Disclosures
ME, LGB, and CO declare that they have no competing interests. RR attended a symposium/conference hosted by a funding agency, Gilead HIV FOCUS programme, from which he receives research funds. RR pays staff for an implementation/research programme grant from Gilead HIV FOCUS for development of HIV testing programmes in Emergency Departments. LC is on the speakers' bureau for the following pharmaceutical companies: GlaxoSmithKline, BMS, Merck, Gilead, Roche, Pfizer, Solvay, Lilly, Serrano, and Tibotec.
Peer reviewers
Marianne Harris, MD
Clinical Assistant Professor
University of British Columbia
Vancouver
Canada
Disclosures
MH is a member of an advisory board and/or speakers' bureau for Gilead Sciences Canada Inc, Merck Canada Inc, and ViiV Healthcare.
William Rodriguez, MD
Assistant Professor of Medicine
Harvard Medical School
Director of Research
Global Health Delivery Project
Harvard School of Public Health
Boston
MA
Disclosures
WR declares that he has no competing interests.
Jeremy Day, BChir, MB
Infectious Disease Physician
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
Vietnam
Disclosures
JD declares that he has no competing interests.
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