E-drug: Use of nevirapine
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South African Medicines Control Council Calls for Alternate
Nevirapine Efficacy Data in 90 Days, Could Ban Use of Drug
from Henry J. Kaiser Family Foundation
August 1, 2003
Officials from South Africa's <http://www.mccza.com/>Medicines
Control Council have said that they will prohibit the use of
nevirapine to prevent mother-to-child HIV transmission unless drug
maker
<http://www.boehringer-ingelheim.com/corporate/home/home.asp>Boehringer
Ingelheim provides data proving that the drug is safe,
<http://www.reuters.com/newsArticle.jhtml?type=topNews&storyID=3188575>Reuters
reports (Quinn, Reuters, 7/30).
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 constitutional obligation to offer the best
treatment available"
(<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=13988>Kaiser
Daily HIV/AIDS Report, 10/11/02).
90 Days
MCC officials said that they have "rejected" a 1999 Ugandan study
that showed the drug's efficacy in preventing vertical HIV
transmission, according to Reuters. MCC Chief Precious Matsoso said
that the study had "numerous procedural flaws," and he gave the
company 90 days to offer additional safety and efficacy information
(Reuters, 7/30). MCC's concerns center around reporting and
documentation in the Uganda trial, although no evidence has been
found to show that the study's conclusions were invalid or that any
participants had been placed at an increased risk of harm,
<http://www.reutershealth.com/archive/2003/07/31/eline/links/20030731elin016.html>Reuters
reports (Chege, Reuters, 7/31).
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 transmission 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
(<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=12205>Kaiser
Daily HIV/AIDS Report, 7/9/02).
In March 2002, FDA officials said that concerns over the drug's
safety were "unwarranted"
(<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=10219>Kaiser
Daily HIV/AIDS Report, 3/25/02). If the drug maker fails to provide
alternate data, the government will revoke nevirapine's temporary
approval, Reuters reports. Matsoso said, "We have to be cautious. If
information is available that meets rigorous scientific standards, we
will look at it" (Reuters, 7/30).
Reaction
South African Health Minister Dr. Manto Tshabalala-Msimang at a news
conference yesterday said, "I think [MCC officials] want to emphasize
the same standards that apply to the developed world and the United
States should apply to the developing world." She added, "We can't
have double standards. We can't have something that's only good for
Africa and not good for developed countries"
(<http://www.nytimes.com/2003/08/01/international/africa/01AIDS.html>Reuters/New
York Times, 8/1).
Kevin McKenna, a Boehringer Ingelheim spokesperson, said that the
company would attempt to work with the MCC and "eradicate their
concerns" about nevirapine, which earlier this month was endorsed by
the <http://www.who.int/en/>World Health Organization (Altenroxel,
<http://www.iol.co.za/index.php?set_id=1&click_id=13&art_id=vn20030730014740857C179525>Star,
7/30). He added, "The overall scientific validity of (the Ugandan
trial) is not questioned. The scientific community accepts this
single, low dose [of nevirapine] is an appropriate medication to
reduce the risk of mother-to-child transmission."
Nathan Geffen of the South African HIV/AIDS advocacy group
<http://www.tac.org.za/>Treatment Action Campaign said, "If new
evidence has come to light, the council should make it available." He
added that if the MCC were to deregister the drug, the government
should provide hospitals and clinics with "adequate warning" to
develop alternative treatment plans, according to
<http://www.bday.co.za/bday/content/direct/1,3523,1399192-6078-0,00.html>Business
Day (Kahn, Business Day, 7/31).
Reprinted with permission
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