PHA-Exchange> Use of Nevirapine

[claudio]

From: "Leela McCullough" <leela at healthnet.org>

> Use of Nevirapine
> -----------------
> 1. Use of Nevirapine in South Africa
> 2. WHO reconfirms its support for the use of Nevirapine
>
> August 1, 2003
>
> Officials from South Africa's Medicines Control Council
have said that they will prohibit the use of nevirap-
> ine to prevent mother-to-child HIV transmission unless drug maker
Boehringer   Ingelheim  provides data proving that the drug is safe.  Last
year, the South African
> government approved nevirapine for universal distribution to state
> hospitals in an attempt to reduce the nation's mother-to-child HIV
> transmission rate. The announcement followed a Pretoria High Court
> ruling in December 2001 that said that the government must provide
> nevirapine to HIV-positive pregnant women through the public health
> system. The government appealed the decision, citing concerns over
> the drug's safety and efficacy, but the Constitutional Court in July
> 2002 denied the appeal, saying that the government's restriction of
> the drug's distribution to 18 pilot sites "fell short of its consti-
> tutional obligation to offer the best treatment available"
 Boehringer Ingelheim in March
> 2002 pulled its FDA application for the right to market nevirapine in
> the United States for the prevention of mother-to-child HIV transmis-
> sion after FDA regulators said they uncovered procedural problems
> with the study. The drug is approved for use in adults in the United
> States, and the U.S. Public Health Service Task Force endorses its
> use for prevention of vertical HIV transmission.
> In March 2002, FDA officials said that concerns over the drug's  safety
were "unwarranted"
If the drug maker fails to
> provide alternate data, the government will revoke nevirapine's tem-
> porary approval, Reuters reports. Matsoso said, "We have to be cau-
> tious. If information is available that meets rigorous scientific
> standards, we will look at it" .
 "The overall scientific va-
> lidity of (the Ugandan trial) is not questioned. The scientific com-
> munity accepts this single, low dose [of nevirapine] is an appropri-
> ate medication to reduce the risk of mother-to-child transmission."

> 2. Meanwhile, WHO reconfirms its support for the use of Nevirapine to
prevent
>    Mother-to-Child Transmission of HIV. (July, 03)
>
> The Division of AIDS, National Institute of Allergy and Infectious
> Diseases, National Institutes of Health, Bethesda has recently re-
> leased the final report (dated March 2003) from the reassessment of
> the trial procedures and results in the HIVNET 012 trial conducted in
> Uganda.
>
> This trial, the first to demonstrate the safety and efficacy of nevi-
> rapine to prevent mother-to-child transmission (MTCT) of HIV, was
> started in Uganda in 1997 and the results were published in 1999.
>
> A single dose of nevirapine given at onset of labour plus a single
> dose to the newborn within 72 hours of birth reduced the risk of HIV
> transmission down to 13%, almost 2-fold lower than a short course of
> Zidovudine started during labour.
>
> WHO continues to support the use of nevirapine in MTCT-prevention
> programmes.
>
> Each year, about 800,000 infants become infected with HIV, mainly
> through mother-to-child transmission.
>
> WHO and its partner United Nations agencies recommend that MTCT pre-
> vention using antiretroviral regimens such as nevirapine should be
> included in the minimum standard package of care for HIV-positive
> women and their children.
>
> WHO is not aware of any information that should lead to a change in
> this recommendation.
>
> For further information please contact:
>
> Dr Tim Farley,
> Department of Reproductive Health and Research
> mailto:FarleyT at who.int
>