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SAATHII Electronic Newsletter
HIV/AIDS Updates
MOTHER AND CHILD SPECIAL
SOURCE: www.aidsmapnews@..., http://www.kaisernetwork.org/dailyreports/hiv, nataphcvhiv@...
Posted on: 09.02.2008
COMPILED BY: Manish Soosai and Dr.
Sai Subhasree Raghavan, SAATHII.
Note: this compilation contains news items about HIV/AIDS
published in the International Electronic Newsletters. Articles in this
and previous newsletters may also be accessed at
http://www.saathii.org/orc/elibrary
IN THIS EDITION…
1. Longer Drug Regimen Found to Help Babies
Avoid HIV from Breastfeeding
2. CROI: Unplanned pregnancy frequent among women after
starting ARVs, need for family planning
3. CROI: HAART use in mothers substantially reduces HIV
infections in breastfeeding infants in Kisumu,
Kenya
4. CROI: Extended infant nevirapine prophylaxis reduces
HIV transmission through breastfeeding
5. Anti-HIV treatment for
babies and children
1. Longer Drug Regimen Found to
Help Babies Avoid HIV from Breastfeeding
nataphcvhiv@...
NY Times
By LAWRENCE K. ALTMAN
Published: February 5, 2008
BOSTON - Over recent years, giving an antiretroviral drug to a woman infected
with the AIDS virus in labor and to her baby at birth has reduced the risk of
transmitting the virus to the baby.
Yet many babies born uninfected go on to acquire H.I.V., the AIDS virus, in the
lengthy period of breast feeding because of contamination of the mother's milk.
Now researchers have found for the first time that the incidence of the virus
among breast-fed infants can be significantly reduced by extending
antiretroviral drugs for much longer periods, up to six months, according to a
number of studies reported on Monday at a scientific meeting here.
“Making breast feeding safe is an urgent need,” Dr. Taha Taha, a researcher
from Johns Hopkins who led a study in Malawi, said at a news conference.
Breast feeding accounts for up to 48 percent of H.I.V. infections among infants
in developing countries, researchers said.
The findings open the way for new prevention strategies in areas where infected
mothers cannot avoid breast feeding for a number of reasons. They include lack
of access to formula, strong cultural traditions of breast feeding and
reluctance to use formula for fear of being stigmatized as being infected, the
federal Centers for Disease Control and Prevention said.
The agency paid for three of the five breast-feeding studies reported at the
15th Conference on Retroviruses and Opportunistic Infections here.
Dr. Elaine Abrams of the Mailman School of Public Health at Columbia
University said the new findings were “likely to have an enormous
impact in this field and inform guidelines and recommendations from the World
Health Organization.”
For infected mothers who have to breast feed because they live where water is
contaminated, the health organization now recommends weaning as soon as a safe
and acceptable replacement feeding is available.
Despite ample documentation of the cost effectiveness and lifesaving benefits
of single-dose therapy with the antiretroviral drug nevirapine, economic and
logistical reasons have limited its use in many developing countries.
Additional studies will be needed to determine the cost effectiveness of
longer-term therapy.
“Breast feeding has proved to be a major stumbling block in preventing further
H.I.V. transmissions from mother to child,” said Dr. Anthony S. Fauci, director
of the National Institute of Allergy and Infectious Diseases.
If independent analyses of the findings from the new studies hold up, as
expected, they “could serve as the basis of a new standard of care,” Dr. Fauci
said in an interview here.
“The next series of studies will need to determine the optimal time for treating
mothers and infants,” said Dr. Fauci. whose agency paid for the fifth
breast-feeding study.
The studies reported here evaluated regimens and the potential of drug
resistance among mothers and babies in India and African countries.
In a study in the Kisumu area of Kenya, along Lake
Victoria, infected mothers took a
combination of antiretrovirals from the 34th week of pregnancy and for the
first six months of breast feeding their children. The newborns were given the
standard single dose of nevirapine to prevent H.I.V. infection that might have
occurred in delivery.
Of 497 newborns, 12, or 2.4 percent, were infected by the end of the first week
of life, from infection in the womb or at birth. An additional 15 infants, or 3
percent, became infected 8 days to 12 months from breast feeding.
In a study in Blantyre, Malawi, more than 3,000 infants received one of three regimens of
antiretrovirals for the first 14 weeks of life. After nine months of
observation, the group that received nevirapine for 14 weeks had the lowest
percent of infected infants, 3.1 percent. That compared with 10 percent among
the control group, which received one dose of nevirapine and one week of
another antiretroviral, AZT.
Another part of the Kisumu study showed that most of the infants infected in
the first six months of life showed laboratory evidence of genetic resistance
to the antiretroviral drugs in the study. But the authors cautioned that the
finding did not mean that the drugs would necessarily fail in treating the
infants.
__________________________________________________________________
2. CROI: Unplanned pregnancy frequent among women after
starting ARVs, need for family planning
Keith Alcorn & Virginia Differding, Tuesday, February 05, 2008
http://www.aidsmap.com/en/news/A102DB42-3C50-4FFC-8920-43BB865FD3BF.asp
Unwanted or unplanned pregnancy
is a significant risk for women with HIV within 18 months of starting
antiretroviral therapy, and in Uganda
few were being offered family planning methods in order to avoid pregnancy,
researchers reported on Tuesday at the Fifteenth Conference on Retroviruses and
Opportunistic Infections in Boston.
French researchers also reported on the impact of replacement, or formula,
feeding on pregnancy rates among women who had taken part in two studies of
prevention of mother to child transmission. Their research showed that after
two years of follow-up, women who had opted for replacement feeding rather than
breastfeeding with early weaning had no greater risk of falling pregnant
despite the fact that breastfeeding reduces the likelihood of pregnancy as long
as it is practiced.
Pregnancy in Uganda
Researchers in Uganda
looked at the trends, predictors, and incidence of pregnancy in a cohort of
women who were receiving ART in the Home Based AIDS Care (HBAC) study.
Antiretroviral therapy is known to restore fertility in HIV-positive women, but
little is known about its effect on the desire to bear children, the incidence
of pregnancy after starting treatment, or women’s family planning choices
during antiretroviral treatment.
The study analysed the incidence of pregnancy and contraceptive choices in
approximately 700 women commencing antiretroviral therapy between 2003 and 2006
in a rural district of Uganda served by the Home Based AIDS Care study, a
programme providing a wide range of services at the community level that is
funded by the US PEPFAR programme. The study was conducted by the US Centers
for Disease Control.
The women were counselled on HIV prevention and family planning, but women who
were interested in family planning services was referred to the nearest
provider. Free condoms were available to study participants on request.
During the first year on ARV therapy, each woman was visited in her home
quarterly and provided answers to an in-depth questionnaire regarding social
and behavioural issues. Among other topics, women were asked about their sexual
activity and desire for children. After the first year, the women were
surveyed, again in their homes, every 6 to 12 months. Contraceptive information
was collected after 18 months on treatment. Median follow-up time was just over
two years.
The women in the study ranged from 18 to 49 years of age. Most of the women (93
to 97%) did not wish to add to their family, but over the course of the study,
nearly 17% did become pregnant. In this study, incidence of pregnancy peaked 12
months after starting treatment, then declined slightly, but showed signs of
returning to the previous peak level after 24 months. Pregnancy was usually
unintended.
There were 140 pregnancies (of which 20 were repeat pregnancies within the
study period), with 106 live births and 21 induced abortions.
Despite not desiring more children, fewer than 8% of the women used dual
contraception by the second year and permanent or semi-permanent family
planning methods were used by just 14% of the women. Only 4.3% were using a
hormonal contraceptive at the end of the study period. Researchers found that
the proportion of women reporting sexual activity increased over 24 months from
less than 25% to nearly 33%.
Independent predictors of pregnancy were young age, being married or living
with a partner, a body mass index over 18.5, and inconsistent condom use.
The investigators advise that patients on ART should be counselled regarding
its effect on restoring health and fertility and that dual contraception
methods should be stressed. Dr Jaco Homsy of US CDC said that family planning
services should be an integral part of ART provision, and should target younger
women and their partners with timely information.
Replacement feeding does not always result in a greater risk of unwanted
pregnancy
A second study on pregnancy rates in HIV-positive women examined whether
non-breastfeeding women were exposed to a greater risk of unwanted pregnancy.
The report, from Cote d’Ivoire,
West Africa, looked at the pattern of subsequent
pregnancies among 724 women from the Ditrame-Plus project (ANRS 1201-1202).
Each of the women received short-course antiretrovirals at the time of
delivery. Afterwards, 54% of the women chose to breastfeed their infants and
46% opted for replacement feeding.
Family planning services, including free contraception methods, were provided
to all women. In each of the two the groups, a roughly equivalent number (~78%)
chose to use contraception methods provided by the clinic – a very high uptake
of contraception for sub-Saharan Africa.
Researchers wanted to see how many new pregnancies occurred in the two years
following delivery and if the method of infant feeding made a difference in
that number. Incidence of pregnancy was noted at 12 and 24 months, with time of
conception gauged by the date of the last (reported) menstrual cycle and an
ultrasound assessment of gestational age.
At 12 months, approximately 4% of the women in each group became pregnant
again. Using a Cox model analysis, two factors that were independently
associated with subsequent pregnancy were advanced clinical HIV disease (WHO
state 3-4) and the death of the infant.
At 24 months, there were significantly more pregnancies in the group of
breastfeeding women. In the two-year study period, 10% of the women who had
used replacement feeding became pregnant again versus nearly 17% of the women
in the breastfeeding group. Additional factors independently associated with
pregnancy incidence were the follow-up clinic and number of living children.
The study reported no difference in infant mortality during the follow-up
period according to feeding mode.
In this trial, women chose whether they would use replacement feeding or
breastfeeding. This raises the question of whether some women chose replacement
feeding because they may have been in a weaker physical state or at a more
advanced disease stage, both conditions that may have influenced fertility.
Valeriane Leroy said that with effective family planning services and access to
contraception methods, replacement feeding does not have to result in more
frequent subsequent pregnancies than in women who breastfeed, despite the
protective hormonal effect of breastfeeding.
References
Viho I et al. Alternatives to prolonged breastfeeding and incidence of
pregnancies among HIV-infected women: The ANRS 1201-1202 Ditrame Plus cohort in
Abidjan, Côte
d'Ivoire, 2001 to 2005. Fifteenth
Conference on Retroviruses and Opportunistic Infections, Boston,
abstract 73. 2008.
Homsy J et al. Incidence and determinants of pregnancy among women receiving
ART in rural Uganda.
Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston,
abstract 74. 2008.
3. CROI: HAART use in mothers substantially reduces HIV
infections in breastfeeding infants in Kisumu,
Kenya
Derek Thaczuk & Virginia Differding, Tuesday, February 05, 2008
http://www.aidsmap.com/en/news/F85145EF-AA4C-4813-AD30-CAB68955F8C4.asp
In a Monday afternoon session at the Fifteenth Conference on
Retroviruses and Opportunistic Infections in Boston,
several investigators reported successes in preventing of mother-to-child
transmission (PMTCT). In the Kisumu Breastfeeding Study, low rates of HIV
infection were seen in children when mothers were kept on three-drug HAART
regimens from late pregnancy through six months of breastfeeding.
Although breastfeeding from an HIV-positive mother poses a risk of HIV
transmission to the infant, breastfeeding is still recommended for HIV-positive
women until their child is six months old, based on evidence that it provides
better health outcomes for the child than formula feeding. Trials are therefore
underway to find ways of reducing the risk of mother-to-child transmission
(MTCT) during breastfeeding.
The Kisumu Breastfeeding Study (KiBS) was a phase IIb PMTCT trial which aimed
to reduce MTCT by using HAART to suppress viral load in HIV-positive pregnant
and nursing mothers, regardless of whether the mothers qualified for treatment
by current access guidelines.
KiBS was a one-arm study with no control arm. Enrolment began in July 2003 and
continued until November 2006; publication of complete results is expected by
January 2009. Women were included if they were HIV-positive, pregnant, and had
decided to breastfeed their babies after counselling on the risks and benefits
of breastfeeding. They had to be not on antiretrovirals and to have no medical
contraindications.
The mothers received HAART from 34 weeks into pregnancy, until six months after
giving birth, and the infants received single-dose nevirapine (2 mg/kg) within
72 hours of birth. The women were advised to exclusively breastfeed and to wean
their children rapidly at six months. From July 2003 to January 2005, the HAART
regimens consisted of Combivir (300 mg zidovudine / 150 mg lamivudine)
twice daily, plus nevirapine. In January 2005, a nevirapine safety warning was
issued regarding hepatotoxicity risk for women with CD4 cell counts greater
than 250 cells/mm3; at that point any such women in the study were
switched to nelfinavir, 250 mg twice daily.
Mothers and children were followed for two years after birth. Infants were
tested for HIV via dried blood spots collected within one week of delivery, at
two and six weeks, and at three, six, nine, twelve, eighteen, and twenty-four
months. PCR testing was done on all samples and ELISA at 18 and 24 months.
Kaplan-Meier methods were used to estimate rates of HIV infection overall, by
infant sex, by maternal enrolment CD4 cell count (≤ 250, or >250 cells/mm3),
and by initial regimen (nevirapine or nelfinavir) for mothers with CD4 cell
counts > 250 cells/ mm3.
From 601 women screened, 522 were enrolled in the study. Their median age was
23 years, median CD4 cell count was 392 cells/mm3, and median viral
load was 4.5 log10. Only 16% were at WHO disease stage 2 or greater.
HIV infection data were available for 502 live-born babies. Of these, 12 (2.4%)
became infected in the first week, 19 (3.9%) after six weeks, 20 (4.1%) after
three months, 27 (5.9%) after twelve months, and 29 (6.7%) after eighteen
months. No differences in infection rates were found by maternal CD4 (p = 0.89)
or by HAART regimen (p = 0.83). The overall rate at 12 months for females was
7.4 (95% CI, 4.6 - 11.9), and for males, 4.5 (95% CI, 2.5 - 8.1) (p = 0.15).
Conclusions
A low 12-month infant HIV transmission rate of 5.9% was achieved using maternal
HAART from 34 weeks of gestation through six months of breastfeeding. When
excluding the children presumed infected during delivery, the transmission
attributable to breastfeeding was only 3.5% by twelve months. There was no
difference in transmission based on maternal CD4 or regimen. HIV transmission
did occur after HAART was discontinued at six months, presumably due to
continued breastfeeding after HAART cessation.
The researchers state that further assessment—of adherence, optimal timing for
breastfeeding cessation, HIV-free survival time, and drug resistance in mothers
and infants—is necessary to determine whether HAART is a feasible, acceptable,
safe, and efficacious strategy for PMTCT among breastfeeding women,
particularly those who do not meet WHO treatment criteria.
The findings on maternal antiretroviral treatment stand as a contrast to other
findings presented yesterday, which
looked at the use of extended nevirapine prophylaxis in infants. Those
studies, although not strictly comparable, found slightly higher rates of HIV
transmission after six or nine months, and this group of findings are likely to
provoke debate about the best way of reducing the risk of HIV transmission
through breastfeeding.
Reference
Thomas T et al. PMTCT of HIV-1 among breastfeeding mothers using HAART: the
Kisumu breastfeeding study, Kisumu, Kenya, 2003-2007. Fifteenth Conference
on Retroviruses and Opportunistic Infections, Boston.
Abstract 45aLB, 2008.
___________________________________________________________________
4. CROI: Extended infant nevirapine prophylaxis reduces
HIV transmission through breastfeeding
Keith Alcorn & Virginia Differding, Tuesday, February 05, 2008
http://www.aidsmap.com/en/news/860CAC18-31FF-4E2C-BDDB-ECCE72E532BB.asp
Giving nevirapine prophylaxis to infants born to
HIV-positive mothers for six to 14 weeks can reduce the risk of HIV infection
through breastfeeding by half, according to findings from randomised studies
conducted in Malawi,
Ethiopia, India
and Uganda
presented on Monday at the Fifteenth Conference on Retroviruses and
Opportunistic Infections in Boston.
In resource-limited settings, up to 40% of infants born to HIV-infected mothers
have become infected by the end of breastfeeding period (which may last up to
18 months). Given the benefits and/or practical need to breastfeed, a variety
of interventions directed at mother, infant, or both have sought to find an
effective manner in which to interrupt transmission.
The World Health Organization recommends that mothers should receive zidovudine
(AZT) from 28 weeks of pregnancy (or as soon as possible thereafter); single
dose nevirapine and AZT/3TCduring labour, and AZT/3TC for seven days after
delivery, while infants should receive single dose nevirapine and AZT for one
week after birth.
But there is still concern that this regimen will not protect infants during
the breastfeeding period, and over the past four years several studies have
been conducted to assess the value of a longer period of antiretroviral
prophylaxis for the infant.
The PEPI-Malawi study
In Malawi, over
3,000 infants who were uninfected at birth were enrolled in an open label,
controlled study of three interventions. Following birth, infants were
randomised to one of three groups for a period of 14 weeks. The “control” group
received a single dose of nevirapine (NVP) and one week of zidovudine (AZT). A
second group of infants received that regimen and extended NVP for 14 weeks
(ExtNVP). The third group of infants received the control regimen plus extended
NVP+ZDV for 14 weeks (ExtNVP/ZDV).
The primary endpoint of the study was HIV infection at 9 months in infants
uninfected at birth. Breastfeeding duration was similar across the three
groups: high (around 90%) from birth to six months and then declining to around
20% by nine months.
At 14 weeks, 10.6% of infants in the control group had seroconverted versus
5.2% in the ExtNVP group and 6.4%% in the ExtNVP/AZT group.
At nine months, 13% of infants in the control group had seroconverted versus
just over 7% in the ExtNVP group and nearly 9% in the ExtNVP/ZDV group. Infant
mortality was just under 9% in the control group and roughly 6.5% in each of
the extended ARV therapy groups.
Combined seroconversion and mortality was 17% for infants in the control group
at nine months. There was no statistical difference in combined seroconversion
and mortality in the two extended therapy groups, with 11% in the ExtNVP group
and 12% in the ExtNVP/ZDV group.
Most deaths were caused by gastroenteritis and pneumonia. Concerning safety,
the number of grade 2 or higher adverse events were similar in each of the
treatment arms.
Use of NVP alone was just as effective as use of NVP/ZDV in reducing HIV
transmission or mortality.
Similar results from combined clinical trial outcomes in Ethiopia,
India, and
Uganda
In similar, but shorter duration, clinical trials in Ethiopia,
India, and Uganda,
results were combined to evaluate outcomes in overall transmission risk at six
months. The studies were testing the SWEN approach – Six Week Extended
Nevirapine. All women received 200 mg of NVP during labour. All infants
received NVP (2mg/kg) at delivery, and were then randomised to receive either
NVP 5mg daily from day 8 to day 48, or an active control dose of liquid
multivitamins. The study was blinded to mothers and investigators by using
opaque dropper bottles or pre-prepared syringes to administer the nevirapine or
active control.
At birth, 986 infants received sd-NVP (2 mg/kg) and 901 received the SWEN
regimen. There were no significant differences between the study arms in
baseline characteristics.
At six weeks of age, infants in the SWEN study had a 50% lower risk of
seroconversion as measured by HIV DNA PCR than did infants who received sd-NVP
(2.5% vs. 5.27%). At six months, infants in the SWEN study had a 20% lower risk
of seroconversion than did infants who received sd-NVP (roughly 7% versus 9%),
but this difference was not statistically significant.
The risk of mortality in the control arm at six months was 3.6% vs. 1.1% in the
SWEN study. The combined risk of either seroconversion or death in the sd-NVP
control arm was 11.6% vs. 8% in the extended NVP group and this difference was
statistically significant. Serious adverse events were similar in both groups.
Again, in these results, extended infant prophylaxis with NVP was safe and
resulted in greater reductions in both HIV-free survival and mortality in
breastfed infants than did sd-NVP.
Nevirapine resistance in infants in the SWEN study
An analysis of nevirapine resistance in infants in the SWEN study was also
carried out among Indian participants, since there is a concern that infants
who become infected with nevirapine-resistant virus during delivery might not
benefit from this approach, and that this might partially explain the
transmission rate in those who received the SWEN regimen.
HIV-1 DNA polymerase chain reaction (PCR) was done within 48 hours postpartum,
at weeks 1, 2, 4, 6, 10, and 14, and at month 6, 9, and 12. Population-based
genotyping was done at a median 28 days after a positive DNA-PCR test.
The timing of HIV infection was divided into four periods:
- in utero, if HIV-positive
by 48 hours (23 infants)
- HIV-positive at week 1
through 6 (19 infants)
- HIV-positive at 10 to 14
weeks (18 infants) and
- HIV-positive at 6 months or
beyond (19 infants).
Of
those infants who were HIV-diagnosed within 6 weeks of age, those who had
received extended-dose NVP had greater NVP resistance (11/12) than did infants
who received sd-NVP only at birth (12/30). The type and extent of resistance
(>1 mutation) did not vary according to NVP dose with the most common
mutations being Y181C, followed by K103N and Y188C.
|
NVP RESISTANCE IN HIV-POSITIVE INFANTS AT 14 WEEKS
|
SUBTOTAL
|
|
Mothers given intrapartum sd-NVP
|
No
|
Yes
|
|
|
Infants w/sd-NVP
|
5/17 (29%)
|
10/25 (40%)
|
15/42 (36%)
|
|
Infants w/extended-dose NVP
|
5/7 (71%)
|
6/11 (55%)
|
11/18 (61%)
|
|
SUBTOTAL
|
10/24 (42%)
|
16/36 (44%)
|
|
NVP resistance in infants at 14 weeks was not affected by whether the mother
had received sd-NVP intrapartum or not.
Practical implications
Although the findings suggest that the extended nevirapine regimen is safe and
effective, post-presentation discussion revealed concern about the high rate at
which infants, infected despite the extended nevirapine regimen, acquired
nevirapine resistance. Dr Jeff Stringer of the Centre for Infectious Disease
Research in Zambia pointed out that based on the findings of the SWEN study, if
1000 infants were treated with the regimen, approximately 21 extra infections
might be averted compared to the use of single-dose nevirapine, but
approximately 53 infants might acquire nevirapine resistance with unknown
consequences for their future prognosis.
Speaking at a press conference to unveil the results, Dr Elaine Abrams of Columbia
University’s ICAP programme, which
has pioneered combined care of mothers and infants in resource-limited settings
with PEPFAR funding, said: “These results are likely to have an enormous impact
on the field and on WHO guidelines.”
But, she acknowledged, “part of the challenge of implementing these findings
will be to link prevention of mother to child transmission services and
maternal child health care.”
One of the attractions of the extended nevirapine regimen is that it is
relatively safe, said Dr Taha Taha of Johns Hopkins University Bloomberg School
of Public Health, but the risk of anaemia and neutropenia would need to be
monitored, and facilities for infant diagnosis using HIV DNA-PCR would also be
needed.
However, others were less enthused about the importance of the findings. Dr
Francois Venter, chair of the South African HIV Clinicians Society, told aidsmap:
"There is a trend for PMTCT intervention to become more and more
complicated, when what I think we need to be working towards is HAART for
mothers and starting treatment when the CD4 count falls below 350 cells."
The findings are likely to be debated in relation to findings from a study of
the effects of maternal HAART on HIV transmission to breastfeeding infants,
also presented during Monday's conference session (see
report here)
References
Taha T et al. Extended infant post-exposure prophylaxis with antiretroviral
drugs significantly reduces postnatal HIV transmission: The PEPI-Malawi study.
15th Conference on Retroviruses and Opportunistic Infections, Boston,
abstract 42LB.
Sastry J et al. Extended-dose nevirapine to 6 weeks of age for infants in Ethiopia,
India, and Uganda:
a randomized trial for prevention of HIV transmission through breastfeeding.
15th Conference on Retroviruses and Opportunistic Infections, Boston,
abstract 43, 2008.
5. Anti-HIV
treatment for babies and children
http://www.aidsmap.com/cms1060206.aspx
Anti-HIV drugs are available for the treatment of babies and children.
Although the use of anti-HIV drugs has been studied less in babies and children
than in adults, there is now a lot of evidence that it works well. It has been
shown that the use of potent HIV treatment has lead to a big fall in the amount
of serious HIV-related illnesses seen in HIV-positive children.
However, as in adults, potent anti-HIV treatment can cause unpleasant
side-effects and needs to be taken at the right time and in the right way to
work properly.
There are fewer drugs available for the treatment of HIV in babies and
children than for adults. Details of the drugs that can be used in babies and
children are provided in the table.
The use of combinations of three or more anti-HIV drugs, often called potent
antiretroviral therapy, in babies has been shown to prevent illness and death
in the first 18 months of life.
Antiretroviral therapy has also been shown to be effective in older infants
and children, many of whom are living longer, healthier lives thanks to
anti-HIV treatment.
The reduction in illness and death in babies and children with HIV in the UK
since treatments became available was recently confirmed by a large study that
found that rates of illness and death fell by over 80%.
As with adults a decision on when is the best time to start treatment in
babies and infants is made on an individual basis. However, if an infant or
child is ill because of HIV, or has a rapidly falling CD4 count and high and
rising viral load, then anti-HIV treatment should be started. Using the PENTA
calculator mentioned earlier, it’s recommended that a baby or child start
anti-HIV treatment if he or she has a risk of developing AIDS of 10% or more in
the next year.
Anti-HIV treatment should be started in children before their immune system
is damaged to such an extent that they are vulnerable to serious, potentially
life-threatening illnesses. In adults this is when the CD4 cell count falls to
about 200. In children the numbers are different. In infants aged under-12
months, a CD4 count of 750 is equivalent to an adult count of 200. The figure
is 500 for children aged one to five. After the age of six, as in adults, a CD4
cell count of about 200 indicates severe immune damage and treatment should be
started. Some centres use the CD4 count percentage as a guide.
There’s some evidence that anti-HIV treatment has the best results if
children start it under five months of age. It’s thought that the use of
treatment in the first few months of a baby’s life works particularly well
because HIV hasn’t yet had the chance to do irreversible damage to the immune
system.
The doses of anti-HIV drugs that babies and children receive are different
to those given to adults. The dose may increase over-time as doses are often
calculated either according to a child’s weight or to their surface area (which
is looked up on a special chart).
Children might also need to take larger doses of a drug than an adult - this
is because babies and children’s bodies process, or metabolise drugs, more
quickly than adults.
In some children it may be necessary to use four drugs rather than three
when starting treatment because children have very high viral loads. Three
NRTIs plus an NNRTI is the usual combination. This means that protease
inhibitors can be used if the first treatment fails. NNRTIs are preferable for
children because they have liquid formulas that taste okay and don’t upset the
stomach and cause diarrhoea.
Side-effects
Most anti-HIV treatments can cause side-effects, such as feeling or being
sick, generally feeling unwell, diarrhoea, headaches, tiredness, fever and high
cholesterol. As with adults, if antiretroviral therapy is causing severe
side-effects, then consideration should be given to changing the drug or drugs
which are causing the problems, if other treatment options are available.
Anti-HIV treatment can cause more long-term side-effects in children,
including lipodystrophy - changes in blood fats and body shape. Lipodystrophy
tends to be more common in older children, probably because of the amount of
time they have been taking treatment. For more information see the booklet Lipodystrophy
in this series.
But on the plus side there is also some evidence that side-effects are less
likely to occur in children, and when they do happen children cope better with
them than adults. This could be because children are less likely to have
lifestyle factors such as drinking or smoking, which make side-effects worse
Table 1 - Anti-HIV drugs
available for the treatment of HIV-positive children
Nucleoside analogues (NRTIs)
Drug name: AZT, zidovudine, Retrovir
Approved for: Infants and children aged three months and over (but
also given to babies to prevent mother-to-baby transmission of HIV)
Liquid formula: Yes
Drug name: ddI, didanosine, Videx
Approved for: Infants and children
Liquid formula: Yes
Drug name: 3TC, lamivudine, Epivir
Approved for: Infants and children aged three months and over
Liquid formula: Yes
Drug name: d4T, stavudine, Zerit
Approved for: Infants and children aged three months and over
Liquid formula: Yes
Drug name: abacavir, Ziagen
Approved for: Infants and children aged three months and over
Liquid formula: Yes
Drug name: FTC, emtricitabine, Emtriva
Approved for: Infants and children aged four months and over
Liquid formula: Yes
Drug name: 3TC/AZT combined, Combivir
Approved for: Adults and children aged over 12 years.
Liquid formula: No
Drug name: 3TC/abacavir combined, Kivexa
Approved for: Adults and children aged over 12 years who weigh over
40kg
Liquid formula: No
Non-nucleoside analogues (NNRTIs)
Drug name: nevirapine, Viramune
Approved for: Infants and children aged two months and over
Liquid formula: Yes
Drug name: efavirenz, Sustiva
Approved for: Children three years or older or weighing over 13kg
Liquid formula: Yes
Protease inhibitors (PIs)
Drug name: lopinavir/ritonavir, Kaletra
Approved for: Children aged six months and over
Liquid formula: Yes
Drug name: nelfinavir, Viracept
Approved for: Infants and children over three years old
Liquid formula: Powder to make into a drink, or tablets can be
crushed but high rate of diarrhoea reported.
Drug name: tipranavir/ritonavir, Aptivus
Approved for: Treatment experienced children and teenagers
Liquid formula: Yes
Drug name: indinavir, Crixivan
Approved for: Children aged four years and over
Liquid formula: No
Drug name: ritonavir, Norvir
Approved for: Children aged two years and over
Liquid formula: Yes, but unpleasant taste
Fusion inhibitor
Drug name: T20, enfuvirtide, Fuzeon
Approved for: Children aged six years and over
Liquid formula: Administered by injection
Adherence
To work properly, anti-HIV drugs need to be taken at the right time and in
the right way at least 95% of the time. Many adults with HIV find this
difficult to achieve, and it can be even more difficult in children, who for
example might not want to take unpleasant tasting medicines, or who might find
it difficult to follow the restrictions on food which some drugs demand.
Essentially, a child will rely on its parents or other adult care-giver to
make sure it receives and takes its medicines. To ensure that this happens, it
is important to consider how the treatment needs of your child will affect you
and your other family members and come up with plans to manage this. Don’t
forget that your own health also matters, and if you are also taking anti-HIV
drugs, make a plan to ensure that you are able to do so.
There is no single adherence tip that will work for all children. Instead,
there may be some strategies that are particularly useful depending on the age
of the child.
For children having great difficulty swallowing medicines, it is possible to
fit a special tube (gastrostomy tube) into the stomach into which medicines can
be directly injected. This means the child does not have to swallow medications
with unpleasant tastes and can be especially helpful for toddlers who cannot
understand why they have to take something, which does not taste pleasant.
Teaching children to swallow pills is another way to avoid the taste of
medicines. Children as young as five can learn a good technique for pill
swallowing, and the team at the HIV clinic can help to teach them.
Pills are also much easier to carry than liquid if you are travelling, or if
you do not want others to see you are on medications. Children on sleepovers or
school trips can carry them discreetly in a little box in their wash bag and
swallow them in the bathroom unobserved.
Once daily treatment may be a way of boosting adherence in older children.
Seeing other children taking medicine is also likely to be helpful for older
children.
Issues regarding adherence can change over time. For example, your child may
want to go around to friends for meals or on school trips meaning overnight
stays. Making sure that your child takes medicines at these times could be very
difficult or impossible. In addition, if your child takes medication in front
of friends, then he or she could be asked questions about why they are doing
so.
Making plans to deal with these situations can also present problems. For
example, you might ask an adult to make sure your child takes its medicines,
but this could lead to pressure to disclose your child’s health status.
Your clinic should be able to provide advice on how to deal with problems
that you will face in getting your child to take medicines at the right time
and in the right way.
To find out more about adherence, see the Adherence booklet in this
series.
Clinical trials
Trials into the safety and effectiveness of anti-HIV drugs need to include
babies and children. If a trial is recommended as being possibly suitable for
your baby or child, you should be given written information to take away and
read, and should have the opportunity to talk through the pros and cons of the
study with a doctor or nurse involved in the study.
Wherever possible you should involve older children in discussions about
whether or not they want to join the trial.
Remember, it is entirely up to you if you want to join a trial. It’s
perfectly okay to say no. The standard of treatment and care your child (or
you) receive will not be affected.
To find out more about trials, see the booklet, Clinical Trials in
this serie
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