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Update: Guidelines for Use of Anti-HIV Drugs During Pregnancy

November 2004

In June 2004, a supplement was added to the Federal Guidelines for the use of anti-HIV drugs during pregnancy. These guidelines focus on mother-to-child transmission of HIV and discuss treatment strategies that can reduce the risk of an HIV-positive woman transmitting HIV to her child. The update included information on the use and potential risks and benefits, to both mother and child, of each of the approved anti-HIV medications. This article will briefly highlight the new recommendations. For more information on pregnancy and HIV, call our hotline at 1-800-822-7422 and ask for Project Inform's publication, "Pregnancy and HIV."

Anti-HIV Medications

The following chart outlines current recommendations for the use of anti-HIV therapies during pregnancy. (A more detailed table and additional information is available through Project Inform's Web site and hotline.)

Recommended During Pregnancy

  • zidovudine (AZT/Retrovir)


  • lamivudine (3TC/Epivir)

  • nevirapine (Viramune)

  • nelfinavir (Viracept)

  • saquinavir (Fortovase)

Alternative Options

  • didanosine (ddI/Videx) *do not use with d4T

  • emtricitabine (FTC/Emtriva)

  • stavudine (d4T/Zerit) *do not use with ddI

  • abacavir (Ziagen)

  • indinavir (Crixivan)

  • lopinavir+ritonavir (Kaletra)

  • ritonavir (Norvir) *use only as a booster

Not Recommended or Not Enough Data to Recommend

  • tenofovir (Viread)

  • zalcitabine (ddC/Hivid)

  • efavirenz (Sustiva)

  • delavirdine (Rescriptor)

  • amprenavir (Agenerase)

  • fosamprenavir (Lexiva)

  • atazanavir (Reyataz)

  • enfuvirtide (Fuzeon)

The Use of Nevirapine (Viramune)

We have known for some time that the serious side effects associated with taking nevirapine, specifically a rash and/or liver toxicity; seem to be experienced more often in women than men. In general, non-pregnant women with pre-treatment CD4+ cell counts above 250 who receive continuous nevirapine are at an increased risk for liver toxicity, including liver failure and death. Men with pre-treatment CD4+ cell counts of above 400 also have higher risk for liver toxicity than men with lower CD4+ counts. This suggests an interaction between sex and immune status, as being risk factors for rash associated liver toxicity. In other words, something about being female or male may put you more at risk for liver toxicity depending on your CD4+ cell count.

The guidelines now include a section on nevirapine and liver and rash side effects. It recommends that pregnant women who start therapy for the first time should take nevirapine with caution, specifically women who have CD4+ cell counts above 250. In addition, pregnancy itself can mimic some of the early symptoms of liver toxicity, for example fatigue or nausea. Doctors should monitor liver enzymes, (i.e., alanine amino transferase), especially in the first 18 weeks of therapy for women who receive nevirapine during pregnancy.

Mode of Delivery

Management of labor and delivery should focus on minimizing the risk of transmission to the child and complications to the mother. Up until recently, an elective Cesarean section was the recommended mode of delivery for HIV-positive pregnant women. Now, given a greater understanding of the correlation between HIV levels and transmission risks, elective C-sections are only recommended for women with viral load above 1,000 near the time of delivery. Whereas women with HIV levels below 1,000 are counseled on the risks and benefits of elective C-section and encouraged to make a choice about natural childbirth or elective C-section.

An elective C-section is normally scheduled at the 37th-38th week of pregnancy. Unlike an emergency C-section, that happens after a woman's water has broken and is oftentimes performed in high-risk situations, an elective C-section is planned and done before a woman's water has broken. The longer an infant is exposed to the torn membranes and blood, the higher the risk of transmission at labor and delivery.

Research shows that babies exposed to ruptured membranes for more than four hours are at significantly higher risk for infection. An elective C-section can minimize the length of time an infant is exposed to the membranes, reducing the risk of HIV transmission. However, like any surgery, an elective C-section comes with potential complications, such as infections. These complications and associated healing time can increase if a woman is HIV-positive.

Recent data underscores the importance of lowering a mother's HIV levels in order to reduce the risk of transmission. A woman with a viral load of 1,000 or below close to the time of delivery has a lower risk of transmitting HIV to her infant. Several studies show that elective C-section offered little additional benefit in lowering HIV transmission risk when a women's viral load is below 1,000. As a result, current guidelines recommend that women with a viral load of less than 1,000 be counseled on the risk and benefits of an elective C-section. This allows a woman more of a choice in how she would like to have her child.

We've come extremely far in terms of preventing mother-to-child transmission. This is a success in the treatment world that is often not discussed or honored. Today many women living with HIV with good medical care and support systems are able to have a healthy child, not infected with HIV.

Back to the Project Inform Perspective November 2004 contents page.

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This article was provided by Project Inform. It is a part of the publication Project Inform Perspective. Visit Project Inform's website to find out more about their activities, publications and services.