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CDC recommends use of raltegravir (Isentress) for PEP

In cases of possible exposure to HIV, the use of PEP (post-exposure prophylaxis) has been found to greatly reduce the risk of HIV infection. For PEP to work, it must be initiated within 72 hours of exposure and taken every day for 28 consecutive days, exactly as directed. Coverage of PEP varies across and even within some provinces; check with your pharmacist or sexual health clinic for information on subsidized access to PEP in your region.

Until recently, the anti-HIV drug dolutegravir (Tivicay) was commonly used as part of PEP regimens, usually along with the drugs TDF + FTC. However, in May 2018, regulatory agencies in Europe and North America issued cautionary statements about the use of dolutegravir in the first month of pregnancy and its possible association with an increased risk of birth defects.

As a result, many regulatory agencies have suggested that doctors avoid prescribing dolutegravir-containing regimens to HIV-positive women of childbearing potential.

Now the U.S. Centers for Disease Control and Prevention (CDC) has made a statement concerning PEP and dolutegravir. The CDC says that healthcare providers prescribing PEP should avoid the use of dolutegravir for:

  • “non-pregnant women of childbearing potential who are sexually active or have been sexually assaulted and who are not using an effective birth control method,” and
  • “pregnant women in early pregnancy since the risk of an unborn infant developing a neural tube defect is during the first 28 days.”

The CDC added:

“The preferred regimen for these women is raltegravir (Isentress) + tenofovir + FTC (emtricitabine). However, individual circumstances may dictate consideration of alternatives (eg. should raltegravir be unavailable).”

“The CDC currently recommends that prior to starting PEP all women of childbearing potential should have a pregnancy test performed. If the PEP regimen for a non-pregnant woman of childbearing potential must include dolutegravir, she should use an effective birth control method until the PEP regimen is completed.”

The CDC also reminds healthcare providers that women who do not get sufficient amounts of the B-complex vitamin folic acid are at increased risk for having babies with a type of birth defect called a neural tube defect. The agency stated: “All women who are of childbearing potential, regardless of pregnancy status, should be provided with at least 400 micrograms of folic acid daily.”

—Sean R. Hosein

REFERENCE:

Centers for Disease Control and Prevention. Interim statement regarding potential fetal harm from exposure to dolutegravir – implications for HIV post-exposure prophylaxis (PEP). Statement. 23 May 2018.