Saturday, May 26, 2012

Under the 2010 guidelines, all HIV positive mothers,

Under the 2010 guidelines, all HIV positive mothers, identified during pregnancy, should receive an extensive course of antiretroviral drugs to prevent mother to child transmission. For more information about the 2010 recommendations, please see AVERT's 2010 WHO Guidelines page. If these extensive drugs are not available, then the 2006 recommended course might be an option and a woman should begin taking AZT after 28 weeks of pregnancy (or as soon as possible thereafter). During labour she should take AZT and 3TC, as well as a single dose of nevirapine. Her baby should receive a single dose of nevirapine immediately after birth, followed by a seven-day course of AZT. The mother should continue taking AZT and 3TC for seven days after delivery, to cut the risk of drug resistance still further.

The WHO says that PMTCT programmes are "strongly encouraged" to implement the 2010 recommendations but acknowledges that this might not be possible for all countries. In this situation, there are previous regimens that have been used and might be implemented, these options are shown in the table below.

WHO guidelines for PMTCT drug regimens in resource-limited settings


Pregnancy Labour After birth: mother After birth: infant
2010 Recommendations option A AZT after 14 weeks
single dose nevirapine; AZT+3TC AZT+3TC for seven days Daily NVP until 1 week after breastfeeding has finished
2010 Recommendations option B Triple ARVs after 14 weeks Triple ARVs Triple ARVs until 1 week after breastfeeding has finished 6 weeks of daily NVP
2006 Recommendations AZT after 28 weeks single dose nevirapine; AZT+3TC AZT+3TC for seven days single dose nevirapine; AZT for seven days
Alternative (higher risk of drug resistance) AZT after 28 weeks single dose nevirapine - single dose nevirapine; AZT for seven days
Minimum (less effective) - single dose nevirapine; AZT+3TC AZT+3TC for seven days single dose nevirapine
Minimum (less effective; higher risk of drug resistance) - single dose nevirapine - single dose nevirapine

Under the 2006 recommendations, if a woman receives at least four weeks of AZT during pregnancy, doctors may choose to omit her dose of nevirapine from the recommended regimen. In this case she will not have to take 3TC during labour, or to take any drugs after birth. However, her baby must still receive nevirapine, and should also receive AZT for four weeks instead of one.

If the woman receives less than four weeks of AZT during pregnancy then her baby should receive AZT for four weeks instead of one.

Triple combinations

The most effective PMTCT therapy involves a combination of three antiretroviral drugs taken during the later stages of pregnancy and during labour. This therapy is essentially identical to the treatment taken by HIV-positive people for their own health, except that it is taken only for a few months, and the choice of drugs may be slightly different. Triple therapy is usually recommended to women in high-income countries, and is becoming more widespread in the rest of the world and the WHO 2010 Guidelines, reflects this. AVERT.org has more information about HIV and pregnancy, including a discussion of these more sophisticated regimens.

HIVNET 012 controversies

In mid December 2004 a news story appeared alleging that side effects from single dose nevirapine during the HIVNET 012 study had been covered up. It claimed that US officials had been warned that nevirapine research "was flawed and may have underreported thousands of severe reactions including deaths."

By the time this news story appeared, a committee from the US Institute of Medicine was already engaged in a major independent review of the design, conduct, results and validity of the HIVNET 012 study. After evaluating extensive material from a variety of sources and reviewing primary source documents from Uganda, the investigation reported its findings in April 2005.

The committee found that the original report on the HIVNET 012 study was "sound, presented in a balanced manner, and can be relied upon for scientific and policy-making purposes." The allegations about unreported deaths were found to be completely untrue. Of the 306 mothers who received nevirapine, 16 experienced serious adverse events, and only one was thought possibly to be due to nevirapine.14

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