Table 3. DHHS Recommendations Regarding [drug: Dolutegravir] Use in Adults and Adolescents With HIV Who Are Pregnant or of Childbearing Potential[ref: DHHS DTG 2018]

Clinical Scenario

Recommendations

ARV Naive or Receiving Non-[drug: Dolutegravir] ART and
Considering Switch to [drug: Dolutegravir]-Based Regimen

Pregnant, < 8 wks from last menstrual period

  • Do not initiate [drug: dolutegravir]

Pregnant, ≥ 8 wks from last menstrual period

  • If ARV naive, initiate [drug: dolutegravir] or another ARV drug
  • If currently receiving non-[drug: dolutegravir] regimen, continue current regimen or switch to [drug: dolutegravir] or another option

Wanting to become pregnant or not using effective contraception

  • Do not initiate [drug: dolutegravir]

Not wanting to become pregnant and using effective contraception

  • [drug: Dolutegravir]-based ART can be considered
  • Pregnancy testing is recommended before [drug: dolutegravir] initiation
  • Discuss potential impact of [drug: dolutegravir] on fetus and importance of effective contraception use

Currently Receiving [drug: Dolutegravir]

Pregnant, < 8 wks from last menstrual period

  • Switch [drug: dolutegravir] to an alternative option or continue [drug: dolutegravir] after weighing the risks and benefits of both approaches
  • Do not stop [drug: dolutegravir] without replacing it with another effective ARV drug
  • Discuss potential risk of [drug: dolutegravir] to the fetus and explain that switching after neural tube has formed is unlikely to confer benefit
  • ARV history, current and previous resistance profiles, patient and fetus safety, tolerance, and drug interaction potential should be considered when determining an optimal alternative to [drug: dolutegravir]

Pregnant, ≥ 8 wks from last menstrual period

  • [drug: Dolutegravir] can be continued
  • Neural tube defects occur in first 4 wks following conception or 6 wks from last menstrual period

Wanting to become pregnant or not using effective contraception and have effective treatment options other than [drug: dolutegravir]

  • Switch [drug: dolutegravir] to an alternative option
  • Do not stop [drug: dolutegravir] without replacing it with another effective ARV drug
  • Discuss potential risk of [drug: dolutegravir] to the fetus
  • ARV history, current and previous resistance profiles, patient and fetus safety, tolerance, and drug interaction potential should be considered when determining an optimal alternative to [drug: dolutegravir]

Wanting to become pregnant or not using effective contraception and with drug-resistant HIV using [drug: dolutegravir] as part of salvage regimen, with no other effective ART options

  • Continue [drug: dolutegravir]
  • Discuss potential risk of [drug: dolutegravir] to the fetus and risks of viral rebound if [drug: dolutegravir] is discontinued, including potential for HIV transmission to the fetus

Not wanting to become pregnant and using effective contraception

  • [drug: Dolutegravir]-based ART can be continued
  • Discuss potential impact of [drug: dolutegravir] on fetus and importance of effective contraception use