The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both issued alerts after preliminary results from an ongoing study reported an increased risk of serious neural tube defects in women who became pregnant while taking dolutegravir-based regimens. The risk appears to be highest in women taking the drug at the time of becoming pregnant or early in the first trimester.
It is recommended that women of childbearing age with HIV currently taking dolutegravir are counselled about this new potential risk. Pregnant women currently taking dolutegravir should not stop their treatment but should discuss the possible risks with their health care provider.
Women of childbearing age with HIV who are trying to become pregnant should discuss alternative antiretroviral therapy regimens with their health care provider. Women of childbearing age with HIV who are not planning to become pregnant may be on dolutegravir-based regimens provided their pregnancy test before starting therapy is negative and they consistently use a reliable method of contraception during treatment.
Both the FDA and the EMA said they would continue to monitor results from the ongoing study and would issue further advice as additional data become available.See Management: approach See Management: treatment algorithm
Globally, 2.1 million people were newly infected in 2015.
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 WHO or US Centers for Disease Control and Prevention (CDC) 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 (PrEP) 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 monograph. 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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