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Justification for the use of Nevirapine
Women
and AIDS Support Network (WASN)
By Barbra Dembedza
December 31, 2002
Use of Nevirapine in chronic treatment
Nevirapine,
also known as Viramune, is recommended for use in combination with
other antiretroviral agents for the chronic treatment of HIV-1 infection.
A resistant strain of the virus emerges rapidly and uniformly where
the drug is used as monotherapy, that is, on its own. Just like
any other AIDS drugs, Virumane should therefore be used in combination
with other ARVs.
Use
of Nevirapine in the Prevention of Parent to Child Transmission
during labour and delivery
Clinical
trials conducted in Uganda on the use of single dose Nevirapine,
have demonstrated that, if one tablet is administered to the mother
during labour and a single oral dose to the infant within 72 hours
of life, the drug reduces HIV-transmission by about 50 percent.
However it is
important to note that the drug has to be used by women who are
not on any other antiretroviral therapy at the time of labour. Because
of its efficacy in the prevention of parent-to-child-transmission
(PTCT) of HIV-1, Nevirapine has been included in the World Health
Organisation (WHO) essential drugs list.
Safety of
a single dose in PTCT prevention
When
used for short course PTCT prevention, Nevirapine is safe. Many
women in South Africa, Uganda, Thailand, the United States and Europe,
have used it and not a single serious side effect has been reported.
Only in isolated incidents have there been reports of minor skin
rashes, which usually disappear after a few days.
Other known
side effects include a liver condition or resistance to future use
of the drug. Studies on the use of Nevirapine have shown that only
22 percent of women who use the drug to prevent PTCT develop resistance
but reverse to normal after 10 months.
Comparisons
that have been made in the use of Nevirapine for prevention of PTCT
and as a chronic medicine to treat people with AIDS, show that there
are serious side effects in the latter. Several trials have been
done specifically for the purpose of testing the safety of Nevirapine
in PTCT and it has been proven that it is very safe to use and that
the benefits far outweigh the side effects.
Nevirapine works
by reducing the viral load, that is, the level of HIV in the mother,
to a very low level thereby reducing the chances of transmission
to the baby. It works by stopping the virus from replicating in
the body. It is a fast-acting and powerful anti-retroviral, which
takes as significant amount of time to be eliminated from the body.
It is easily absorbed into the body and passed readily to the placenta,
making it a very valuable option in the prevention of PTCT. If the
virus has recently entered the baby’s blood stream, then the high
levels of ARV medicine can prevent the virus from becoming viable.
The
donation to Zimbabwe
In
2000, German pharmaceutical giant, Boehringer-Ingelheim made a donation
of Nevirapine to 29 third world countries, among them Zimbabwe.
The donation, which would last five years, was intended at reducing
parent-to-child-transmission of HIV under the following conditions.
- The drug
is made available for free to eligible countries based on the
expressed interest of the respective government.
- It must be
registered for the prevention of Parent/Mother to Child Transmission
according to local regulatory laws in the receiving country.
- Non Governmental
Organisations, charitable organisations and other healthcare providers
are eligible to receive and administer the drug, but there has
to be written approval from the government.
Boehringer-Ingelheim,
upon approval of application, would cover the costs of insurance
and shipping of the agreed quantities up to the point of entry into
the country, but would not foot any additional costs such as local
handling, taxes, duties or the distribution to the health facilities.
Since the inception
of the Zimbabwean programme, it is of major concern that distribution
of the drug has not been rolled out to benefit the generality of
women. This is especially considering the fact that the local programme
was launched in February 2001. The speed at which the programme
is being implemented is of major concern given the fact that statistics
have shown that one in every three pregnant women who attend anti-natal
clinics is HIV positive.
What are
the challenges
In
order to fully utilize the donation, the following issues have to
be urgently addressed, if the programme is to be effective in Zimbabwe.
- The need
to make available as much information as possible to women who
are the immediate beneficiaries.
- The need
to urgently roll out the programme for the benefit of all women.
- The need
to revamp the health delivery system and address issues of access
to health centers by most women.
- The need
to make available essential drugs for the treatment of Opportunistic
infections.
- The need
for the greater involvement of men in the PTCT programme.
- The need
to mainstream gender in the PTCT programme.
- The need
to address health workers’ attitude.
- The need
for transparency in the centers that are currently administering
the drug.
- The need
for a more concerted effort by all key stakeholders (government,
AIDS Service Organisations and NGOs).
- The urgent
need to come up with a comprehensive gender sensitive treatment
plan that addresses PTCT.
- There is
need to put in place strategies that ensure availability of the
drug after the five years.
- There is
need to open up the channels of distribution to more centers that
are not necessarily government institutions. The programme should
also be rolled out to traditional midwives, given that the high
cost of health care has prompted many women to give birth at home.
- There is
need to continuously reinforce the need for protection from infection
at all levels.
Given the
fact that Nevirapine has proved effective in the prevention of
PTCT of HIV-1, there is need to continuously press for its availability
in all health centers throughout the country. This is particularly
so in resource poor settings, such as the case with Zimbabwe where
the majority of women are still not in a position to access treatment,
hence cannot be denied access to Nevirapine under the pretext
that there will be side effects through use of a single drug.
The argument
advanced by opponents of PTCT, who claim that the mother is being
used as a safe passage to deliver a healthy baby while nothing
is being done to prolong her life is feeble. As WASN, we strongly
emphasize that the position of women will not be compromised and
the agenda of women will always be given priority. In fact the
Nevirapine campaign is a tool that we will use to fight for improved
access to treatment by women.
Of paramount
importance, however, is the urgent need to de-stigmatize HIV/AIDS
as stigma has remained the main reason for the low uptake of interventions,
particularly by women.
UNAIDS Director,
Peter Piot, believes that the greatest enemy in the war against
the AIDS pandemic is stigma and observations made in the course
of WASN’s work support this view.
As long as we
have not dealt with the challenges that stem from stigma, the war
is not over.
Visit the WASN
fact
sheet
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