AFRO-NETS> Use of Nevirapine

[Leela McCullough <leela@healthnet.org>]

Use of Nevirapine
-----------------
 
 
1. Use of Nevirapine in South Africa
2. WHO reconfirms its support for the use of Nevirapine
 
 
1. South African Medicines Control Council Calls for Alternate Nevi-
   rapine Efficacy Data in 90 Days, Could Ban Use of Drug
 
from Henry J. Kaiser Family Foundation
 
August 1, 2003
 
Officials from South Africa's Medicines Control Council 
http://www.mccza.com/ have said that they will prohibit the use of nevirap-
ine to prevent mother-to-child HIV transmission unless drug maker Boehringer 
Ingelheim http://www.boehringer-ingelheim.com/corporate/home/home.asp pro-
vides 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 consti-
tutional 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 transmis-
sion, 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 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 
(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 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" (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=vn20030730
014740857C179525 Star, 7/30). He added, "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." 
Nathan Geffen of the South African HIV/AIDS advocacy group Treatment 
Action Campaign http://www.tac.org.za/ 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
 
--
2. 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.
 
Concerns about the trial were raised in March 2002 when claims 
emerged that certain serious adverse events had not been properly re-
ported.
 
The Division issued a statement with the final report that concludes: 
"In summary, the re-monitoring of the study determined that nevirap-
ine, 200mg orally given to the mother at delivery and 2mg/kg given to 
the neonate within 72 hours, is safe and effective.
 
However, the conduct of the study lacked the necessary documentation 
to support a request to the FDA to consider this study as a stand 
alone pivotal trial." Nevirapine has been registered in the USA, 
countries of the European Union and numerous other countries for the 
treatment of AIDS (in combination with other antiretroviral agents), 
and is also registered for MTCT prevention in many countries world-
wide.
 
Nevirapine is recommended by the US Public Health Service Task Force 
for MTCT prevention among women in labour who have had no prior ther-
apy and is included for both treatment and MTCT prevention purposes 
in the WHO Model List of Essential Medicines, which is updated on a 
regular basis.
 
In October 2000, WHO in partnership with UNAIDS, UNICEF and UNFPA, 
convened a technical consultation to review all available evidence on 
the safety and effectiveness of short-course antiretroviral drug-
based interventions to reduce the risk of MTCT.
 
The consultation concluded that all regimens which had been shown to 
be safe and effective in controlled clinical trials could be used in 
MTCT-prevention programmes. These regimens included zidovudine alone 
or in combination with lamivudine, as well as nevirapine.
 
Since the consultation, further research conducted in South Africa 
has demonstrated the safety and efficacy of nevirapine as well as the 
zidovudine and lamivudine combination. Scaling-up MTCT-prevention 
programmes in resource-limited settings to reach more HIV-positive 
mothers and prevent any further infants being infected with HIV is a 
major challenge, to which many governments, non-governmental organi-
zations, international aid agencies and WHO are committed.
 
While nevirapine is only one of several regimens, which has been 
shown to be safe and effective, the low cost and simplicity of use of 
the regimen makes it particularly attractive.
 
Recommendations
 
WHO continues to support the use of nevirapine in MTCT-prevention 
programmes. WHO agrees with the National Institutes of Health report 
and the accompanying statement, which emphasize that there is no evi-
dence that the scientific data from the HIVNET012 study demonstrating 
the safety and efficacy of nevirapine are invalid.
 
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@who.int
 
or
 
Dr Isabelle de Zoysa
Department of HIV/AIDS
mailto:DeZoysaI@who.int
 
Source:
http://www.who.int/reproductive-health/rtis/MTCT_consultation.en.html
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