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 randomized, 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 optimization strategy for people with HIV currently on oral antiretroviral therapy with documented viral suppression for at least 3 months who meet certain criteria.
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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HIV infection is a pandemic infectious disease whose impact on societies is without precedent.
Globally, an estimated 38 million people were living with HIV at the end of 2019, with 1.7 million people newly infected in 2019.
Most people are infected through sexual contact, before birth or during delivery, during breast-feeding, or when sharing contaminated needles and syringes.
Diagnosis is established using an HIV antibody test and confirmed using a more specific test. Patients should be clinically staged according to World Health Organization or Centers for Disease Control and Prevention criteria.
Guidelines recommend that all patients infected with HIV, regardless of CD4 cell count, should start antiretroviral therapy (ART) as soon as possible.
Pre-exposure prophylaxis with daily ART reduces the risk of HIV infection in adults who are at high risk for HIV acquisition and is recommended in select patients.
Diagnosis and management varies between resource-intensive settings and resource-limited settings.
HIV infection is caused by a retrovirus that infects and replicates in human lymphocytes and macrophages, eroding the integrity of the human immune system over a number of years, culminating in immune deficiency and a susceptibility to a series of opportunistic and other infections as well as the development of certain malignancies.
At the initial consultation with the medical practitioner, an infected patient may be at any stage of the natural history from acute to chronic infection, ranging from asymptomatic through to severely ill. The initial assessment is key for prognosis and formulation of short- to long-term management plans.
History and exam
- fevers and night sweats
- weight loss
- skin rashes and post-inflammatory scars
- oral ulcers, angular cheilitis, oral thrush, or oral hairy leukoplakia
- wasting syndrome
- changes in mental status or neuropsychiatric function
- recent hospital admissions
- tuberculosis (TB)
- medical comorbidities
- sexual activity
- generalized lymphadenopathy
- Kaposi sarcoma
- genital STIs
- chronic vaginal candidiasis
- periodontal disease
- retinal lesions on fundoscopy
- shortness of breath on exertion, cyanosis on exertion, dry cough, silent chest on auscultation
- 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
- serum HIV enzyme-linked immunosorbent assay (ELISA)
- serum HIV rapid test
- HIV noninvasive 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 hemagglutination test
- rapid plasma reagin
- tuberculin skin test
- CBC with differential
- serum electrolytes
- serum creatinine
Associate Professor of Medicine
Feinberg School of Medicine, Northwestern University
CJA is a consultant on an educational program on HIV and aging with ViiV, has received speaker fees for talks on HIV and aging 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.
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.
ME, LGB, and CO declare that they have no competing interests. RR attended a symposium/conference hosted by a funding agency, Gilead HIV FOCUS program, from which he receives research funds. RR pays staff for an implementation/research program grant from Gilead HIV FOCUS for development of HIV testing programs 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.
Clinical Assistant Professor
University of British Columbia
MH is a member of an advisory board and/or speakers' bureau for Gilead Sciences Canada Inc, Merck Canada Inc, and ViiV Healthcare.
Assistant Professor of Medicine
Harvard Medical School
Director of Research
Global Health Delivery Project
Harvard School of Public Health
WR declares that he has no competing interests.
Infectious Disease Physician
Oxford University Clinical Research Unit
Hospital for Tropical Diseases
Ho Chi Minh City
JD declares that he has no competing interests.
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