Updated guidelines published by the US Department of Health and Human Services now recommend doravirine-based antiretroviral regimens as an initial option for the treatment of HIV infection in some groups of patients.
According to the guideline, doravirine-based treatment is now recommended as an initial regimen in certain clinical situations (e.g., patients who cannot tolerate integrase strand transfer inhibitors [INSTIs] and wish to use an NNRTI with a lower risk of adverse effects). However, it is not yet recommended as an initial regimen in most people due to a lack of data comparing doravirine to INSTI-based regimens, the current treatment of choice.
Doravirine, a new non-nucleoside reverse transcriptase inhibitor (NNRTI), was approved by the US Food and Drug Administration in August 2018 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history. The drug is available as a single-ingredient formulation or in a co-formulation with lamivudine and tenofovir disoproxil. It has also been recommended for approval in Europe, with a final decision pending.
Approval was based on two clinical trials which showed that doravirine/tenofovir/lamivudine was non-inferior to efavirenz- and darunavir/ritonavir-based regimens. Doravirine is generally better tolerated, with a more favourable lipid profile, a lower incidence of rash, and fewer central nervous system adverse effects compared to efavirenz. The updated DHHS guideline also incorporates recommendations for the use of dolutegravir in women of childbearing potential and pregnancy.See Management: approach See Management: treatment algorithm
Globally, 1.8 million people were newly infected in 2017.
Most people are infected through sexual contact, before birth or during delivery, during breastfeeding, 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 US 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 a pandemic infectious disease whose impact on societies is without precedent. It 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 unwell. The initial assessment is key for prognosis and formulation of short- to long-term management plans.
AIDS (a syndrome of a constellation of infections, conditions, or malignancies) occurs as a result of HIV infection, usually after approximately 6 to 9 years of infection.
Assistant Professor of Medicine
Northwestern Memorial Hospital
CJA has been a member of an advisory board on HIV, aging and telomeres for Viiv, and has done consultant work as a member of DSMBs for ABIVAX, Atea, and Biotron. He has also received a grant for Investigator Sponsored Research from Gilead.
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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