Which HIV drugs are recommended for HIV+ pregnant women?
To help make sense of what is—and what is not—known about the safety and effectiveness of variousHIV drugs during pregnancy, the United States Department of Health and Human Services (DHHS) has put together treatment guidelines to help HIV-infected pregnant women and their doctors determine which medications to use.The following table is based on a more technical table published in the November 2, 2007, version of the Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States. It focuses on the pharmacokinetics (the study of drug levels in the body) of various HIV drugs in pregnant women, safety concerns associated with each drug and the best time to consider these drugs during pregnancy.
Drug levels in the body are the same during pregnancy as they are in nonpregnant women. The standard dose of Retrovir can be used (300mg, twice a day).
No evidence of harm to the fetus or evidence of birth defects. Studies have determined Retrovir to be safe for women and their infants.
Retrovir is a preferred NRTI for use in combination with other HIV drugs during pregnancy. This recommendation is based on the results of several clinical trials confirming that the drug is safe and effective. Retrovir should typically be included in a regimen for pregnant women unless significant side effects occur. It should not, however, be used at the same time as Zerit (stavudine; d4T).
Drug levels in the body are the same during pregnancy as they are in nonpregnant women. The standard dose of Epivir can be used (300mg, once a day).
No evidence of harm to the fetus or evidence of birth defects. Studies have determined Epivir to be safe for women and their infants.
Epivir, combined with Retrovir, has been studied extensively in clinical trials involving HIV-positive pregnant women. In turn, Epivir and Retrovir are considered to be the two preferred NRTIs to use in HIV drug combinations during pregnancy.
Drug levels in the body are the same during pregnancy as they are in nonpregnant women. The standard doses of Videx and Videx EC can be used (click here to learn more).
Lactic acidosis, which can be fatal, has been reported in HIV-positive pregnant women taking Videx in combination with Zerit (stavudine; d4T).
Videx is an alternative NRTI option for use during pregnancy. Videx can be considered, particularly if Retrovir and/or Epivir cannot be taken (for example, because of side effects or drug resistance). Videx should not be used in combination with Zerit.
No studies involving HIV-positive pregnant women have been conducted.
No studies involving HIV-positive pregnant women have been conducted.
Even though Emtriva has not yet been studied in HIV-positive pregnant women, the drug is very similar to Epivir and, as a result, is considered to be a safe and effective alternative option.
Drug levels in the body are similar during pregnancy as they are in nonpregnant women. The standard dose of Zerit can be used (40mg, twice a day).
No evidence of harm to the fetus or evidence of birth defects. However, lactic acidosis, which can be fatal, has been reported in HIV-positive pregnant women taking Zerit in combination with Videx or Videx EC.
Zerit is an alternative NRTI option for use during pregnancy. Zerit can be considered, particularly if Retrovir cannot be taken (for example, because of side effects). However, Zerit should not be used in combination with Videx/Videx EC. Pregnant women should also avoid combining Zerit with Retrovir.
Drug levels in the body are similar during pregnancy as they are in nonpregnant women. The standard dose of Ziagen can be used (600mg once daily, or 300mg twice daily).
Approximately 5% to 8% of nonpregnant HIV-positive people who take Ziagen are allergic to it and can experience a "hypersensitivity reaction." This can be serious and may require that Ziagen therapy be stopped. The rate of hypersensitivity in HIV-positive pregnant women has not yet been determined. A blood test to determine if someone is at risk for this hypersensitivity reaction is now available.
Ziagen is an alternative NRTI option for use during pregnancy. Ziagen can be considered, particularly if Retrovir and/or Epivir cannot be taken (for example, because of side effects or drug resistance).
Very little information available. Drug levels might be lower during third trimester of pregnancy. Phase I clinical trial in late pregnancy being conducted.
Studies in monkeys show decreased fetal growth and fetal bone problems. Clinical trials involving humans, including children, also show bone problems. More research is needed to make sense of these problems.
Because results are not yet available from clinical trials evaluating the safety of Viread during pregnancy, along with the concerns regarding bone development, Viread should only be used during pregnancy when preferred or alternative NRTIs are not possible (for example, because of side effects or drug resistance).
Not Recommended:
Drug Name
Pharmacokinetics during pregnancy
Side effect concerns during pregnancy
Should it be used during pregnancy?
Hivid
(zalcitabine; ddC)—no longer available in the United States.
No studies involving HIV-positive pregnant women have been conducted.
Studies in rodents indicate that birth defects are possible.
Because of the possibility of birth defects, Hivid should not be used during pregnancy unless preferred and alternative NRTIs cannot be used (for example, because of side effects or drug resistance).
Drug levels in the body are the same during pregnancy as they are in nonpregnant women. The standard dose of Viramune can be used (200mg, twice a day).
No evidence of birth defects. Rash is a common side effect, particularly among women with CD4 cell counts higher than 250. It is not clear if pregnancy further increases this risk.
Viramune should be used with caution in pregnant women with CD4 cell counts higher than 250. If Viramune is used, blood tests to check liver enzyme levels should be performed frequently during the first 18 weeks of therapy.
No studies involving HIV-positive pregnant women have been conducted.
Sustiva has caused neural tube defects (a birth defect occurring in the brain or spinal cord) in infants born to women who took Sustiva during the first three months of pregnancy. It has also caused serious birth defects in infants born to monkeys receiving Sustiva during the first three months of pregnancy.
Sustiva should be avoided during the first trimester of pregnancy, when fetuses are most susceptible to drug toxicities. Using Sustiva during the second or third trimester (the last six months of pregnancy) is possible if other options (e.g., Viramune) are not available.
No studies involving HIV-positive pregnant women have been conducted.
Studies in rodents indicate that birth defects are possible.
Because of the possibility of birth defects, Rescriptor should not be used during pregnancy unless other options cannot be used (for example, because of side effects or drug resistance).
Using the older capsule formulation of Kaletra, blood levels dropped significantly during the third trimester of pregnancy. Increasing the dose, from three capsules twice a day to four capsules twice a day, returned Kaletra blood levels to normal during the third trimester.
No evidence of harm to the fetus or evidence of birth defects. One study demonstrated that Kaletra is safe for women and their newborns when taken during pregnancy.
Because most studies completed to date involved the older capsule version of Kaletra, official dosing recommendations using the newer tablet version cannot be made. Some experts recommend using the standard dose throughout pregnancy—two tablets twice a day—along with regular monitoring of viral load to ensure that treatment is working well. Other experts recommend increasing the tablet dose to three tablets twice a day during the third trimester, followed by a dose reduction to two tablets twice a day following delivery. Once-daily Kaletra is not recommended during pregnancy.
Crixivan levels in the bloodstream, using a dose of 800mg three times daily, are significantly lower during pregnancy than they are in nonpregnant women. However, in one study involving 18 HIV-positive pregnant women, reductions in viral load were seen throughout pregnancy.
Crixivan can cause increased bilirubin levels in nonpregnant HIV-positive women. Increased bilirubin levels can cause jaundice (yellowing of the eyes, skin, and under the nails) and liver problems, particularly in infants. Thus, it is possible that women who take Crixivan are at a higher risk of delivering babies born with elevated bilirubin levels. However, Crixivan does not easily get into a fetus's bloodstream during pregnancy, which means that it might be protected against elevated bilirubin caused by Crixivan.
Crixivan is an alternative PI option for use during pregnancy. Crixivan can be considered, particularly if Kaletra cannot be taken (for example, because of side effects). While Norvir (ritonavir) should be used to boost blood levels and the effectiveness of Crixivan, optimal Norvir/Crixivan dosing has not yet been determined.
Early studies demonstrated that levels of Norvir in the bloodstream are lower than normal during pregnancy.
Limited information from clinical trials evaluating the safety of Norvir in HIV-positive pregnant women.
Because Norvir levels are lower than normal during pregnancy, it is recommended that Norvir be used only to boost other protease inhibitors (e.g., Invirase or Crixivan) if used by HIV-positive pregnant women.
Invirase
(saquinavir soft gel capsules or tablets) boosted with low-dose Norvir (ritonavir)
Adequate drug levels are achieved in pregnant women using Fortovase (800mg)—an older version of saquinavir—combined with Norvir (100mg), both given twice a day. Less is known about the only form of saquinavir (Invirase) now on the market, although some data suggest that 1,000mg Invirase (two 500mg tablets), combined with 100mg Norvir, taken twice a day, achieves adequate saquinavir levels during pregnancy.
No evidence of harm to the fetus or evidence of birth defects. Studies have found that Fortovase or Invirase, combined with Norvir, is safe for women and their newborns when taken during pregnancy.
When Fortovase was available, saquinavir was a preferred protease inhibitor to use during pregnancy. Because less is known about the use of Invirase soft-gel capsules or tablets in pregnancy, saquinavir is now an alternative PI option, particularly if Kaletra cannot be taken (for example, because of side effects). If used, Invirase capsules or tablets should be combined with Norvir to boost their blood levels and effectiveness.
The standard dose of Viracept, 1250mg twice a day, achieves adequate drug levels, although blood concentrations of the drug can decrease during the third trimester of pregnancy.
In September 2007, Pfizer reported the discovery of a manufacturing impurity, ethyl methanesulfonate (EMS), in U.S. batches of Viracept. As EMS has been found to be cancerous and capable of causing birth defects in animals, Pfizer and the FDA advise that HIV-positive pregnant women avoid using Viracept until further notice. (The EMS warning was lifted by the FDA in May 2007. The DHHS has not yet reconvened its expert panel to discuss the use of Viracept during pregnancy.)
Due to the discovery of ethyl methanesulfonate (EMS) in U.S. batches of Viracept, HIV-positive pregnant women should avoid using this protease inhibitor until further notice. (The EMS warning was lifted by the FDA in May 2007. The DHHS has not yet reconvened its expert panel to discuss the use of Viracept during pregnancy.)
Not Enough Data to Recommend Use:
Drug Name
Pharmacokinetics during pregnancy
Side effect concerns during pregnancy
Should it be used during pregnancy?
Agenerase
(amprenavir)—no longer available in the United States.
Limited information from clinical trials evaluating the pharmacokinetics of Agenerase in HIV-positive pregnant women.
Oral solution (Agenerase liquid) should not be taken by pregnant women because of the high amounts of propylene glycol, which may not be processed by the body correctly during pregnancy.
Not enough pharmacokinetic or safety data to recommend.
A few studies involving a small number of women suggest that Reyataz and Norvir (ritonavir)-boosted Reyataz achieve adequate drug levels when standard doses are used during pregnancy.
Reyataz can cause increased bilirubin levels in nonpregnant HIV-positive people. Increased bilirubin levels can cause jaundice (yellowing of the eyes, skin, and under the nails) and liver problems, particularly in infants. Thus, it is possible that women who take Reyataz are at a higher risk of delivering babies born with elevated bilirubin levels. However, protease inhibitors do not easily get into a fetus's bloodstream during pregnancy, which means that it might be protected against elevated bilirubin caused by Reyataz.
Not enough pharmacokinetic or safety data to recommend.
Limited information from clinical trials evaluating the pharmacokinetics of Fuzeon in HIV-positive pregnant women
Limited information from clinical trials evaluating the safety of Fuzeon in HIV-positive pregnant women
Because results are not yet available from clinical trials evaluating the safety of Fuzeon during pregnancy, the DHHS does not yet recommend that HIV-positive pregnant women use this drug.
Limited information from clinical trials evaluating the pharmacokinetics of Selzentry in HIV-positive pregnant women
Limited information from clinical trials evaluating the safety of Selzentry in HIV-positive pregnant women
Because results are not yet available from clinical trials evaluating the safety of Selzentry during pregnancy, the DHHS does not yet recommend that HIV-positive pregnant women use this drug.
Limited information from clinical trials evaluating the pharmacokinetics of Isentress in HIV-positive pregnant women
Limited information from clinical trials evaluating the safety of Isentress in HIV-positive pregnant women
Because results are not yet available from clinical trials evaluating the safety of Isentress during pregnancy, the DHHS does not yet recommend HIV-positive pregnant women use this drug.
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