Last reviewed: September 2018
Last updated: May  2018

US CDC no longer recommends dolutegravir as part of PEP regimen in early pregnancy or women of childbearing age

The US Centers for Disease Control and Prevention (CDC) have updated their HIV post-exposure prophylaxis (PEP) guidelines to recommend against the use of regimens containing dolutegravir in women who are in the early stage of pregnancy or in those who may become pregnant.

The CDC recommends emtricitabine/tenofovir and raltegravir (rather than emtricitabine/tenofovir and dolutegravir) as the preferred option in sexually active women of childbearing potential who are not using an effective birth control method, and in pregnant women in early pregnancy.

This interim recommendation is based on a preliminary unscheduled analysis of an ongoing surveillance study that has reported an increased risk of serious neural tube defects in women who became pregnant while taking dolutegravir-based regimens (0.9% compared to 0.1% in women not taking dolutegravir). The risk appears to be highest in women taking the drug at the time of becoming pregnant or early in the first trimester. No cases were reported in infants born to women who started dolutegravir later in pregnancy.

All women of childbearing potential should have a pregnancy test before starting PEP. If dolutegravir is required in these women (e.g., raltegravir is not available), they should be advised to use effective birth control until the PEP regimen is completed.

See Management: approach See Management: treatment algorithm

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • exposure to HIV within past 72 hours
  • breakage, slippage, or nonusage of a condom
  • history of ejaculation from source
  • trauma or skin break
  • genital ulcers
  • source from high-risk group for HIV infection
  • source from geographic area with high HIV prevalence
  • high-risk sexual history in exposed person
  • detectable HIV viral load in source

Other diagnostic factors

  • history of negative HIV test in source
  • source with hepatitis co-infection
  • antiviral HIV resistance in source
  • current prescription or nonprescription medications
  • history of drug allergies
  • flu-like illness

Risk factors

  • blood transfusion from HIV-positive donor
  • sharing injecting equipment
  • needlestick injury
  • receptive anal intercourse
  • receptive vaginal intercourse
  • mucus membrane exposure
  • insertive anal intercourse
  • insertive vaginal intercourse
  • receptive oral sex (fellatio)

Diagnostic investigations

1st investigations to order

  • HIV antigen/antibody blood test
  • rapid point of care (POCT) HIV test
  • renal function tests
  • serum aspartate aminotransferase or alanine aminotransferase
  • hepatitis B serology
  • hepatitis C serology
  • syphilis serology
  • pregnancy test
Full details

Investigations to consider

  • HIV viral load if symptoms of HIV seroconversion
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Genitourinary and HIV Specialist Registrar

Department of HIV

Harrison Wing

Guy’s and St Thomas Hospital NHS Foundation Trust

London

UK

Disclosures

MJL declares no competing interests.

HIV consultant and Honorary Senior Lecturer KCL

Department of HIV

Harrison Wing

Guy’s and St Thomas Hospital NHS Foundation Trust

London

UK

Disclosures

JF has received scientific grants from Gilead Sciences and Merck.

Dr Ming Jie Lee and Dr Julie Fox would like to gratefully acknowledge Dr Jennifer A. Johnson, Dr Paul Sax, Dr Rebecca Plank, Dr Michael Brady, Dr Emily Cheserem, and Dr Claire M. Naftalin, the previous contributors to this monograph. JAJ declares that she has no competing interests. PS serves as a consultant for Abbott, BMS, Gilead, GSK, Merck, and Janssen. He receives grant support from BMS, Gilead, and GSK. EC has been sponsored by GlaxoSmithKline for several conferences and sponsored by Gilead Sciences, Bristol-Myers Squibb Pharmaceuticals, and Abbott Laboratories to attend various educational programs. CMN has been sponsored by Bristol-Myers Squibb Pharmaceuticals to attend an educational program. CMN is an author of a reference cited in this monograph. MB not disclosed. RP declares that she has no competing interests.

Peer reviewers VIEW ALL

Clinical Director

HIV/AIDS Services

Royal Free Hampstead NHS Trust

London

UK

Disclosures

MJ declares that she has no competing interests.

Chief Medical Officer

Foundation for Innovative New Diagnostics (FIND)

Campus Biotech

Geneva

Switzerland

Disclosures

Not disclosed.

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