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1. MANAGEMENT OF THE HIV POSITIVE MOTHER AND PREVENTION OF

MOTHER-TO-CHILD TRANSMISSION OF HIV / PREGNANCY AND ARV

1.1 Counselling and Voluntary testing for HIV in pregnant women.

The effectiveness of a program for the reduction of parent to child transmission of

HIV infection depends on the mother’s HIV status being known so that she can

receive antiretroviral therapy and counseling regarding infant feeding and other

important issues. With the availability of ARV, the woman herself also potentially

derives benefit from knowing her HIV status as, if positive, she can enter the

program of monitoring and when necessary, receive ARV.

Since the start of the MTCT pilot program in South Africa, testing rates have

varied widely between different centers. A recent study has shown that provinces

where all women receive individual pre-test counseling before making a decision

regarding HIV testing have a much higher HIV test uptake rate than provinces

where women receive group information and then may choose to have individual

counseling().

1.1.1 Counselling and voluntary testing.

All women attending antenatal clinic must receive individual counseling about

HIV testing before making a decision regarding the test. Group information may

be provided but should not replace individual pre-test counseling. Pre-test

counseling is not optional – it is a standard part of management for each woman

attending antenatal clinic, just as blood pressure measurement is. Counselling

should be performed in a private room by lay counselors who have been trained

for this purpose. All women need to give consent before undergoing HIV testing.

Couples testing is to be strongly encouraged, with the couple receiving their pre-

test counseling together and making the decision about HIV testing together.

Provisions need to be made for partner testing at antenatal clinics. Couples

testing may be facilitated by offering antenatal clinic services at times when men

may more easily attend clinic with their wife/partner, eg in the evenings or

weekends.

For all individuals agreeing to HIV testing, the test is to be done on site with rapid

testing. For positive tests a second rapid test is performed. For negative tests,

no further HIV testing is performed. If women leave the clinic before being

informed of their HIV test result, some will not return to that clinic to receive the

result, thus missing the potential benefit which can be provided to themselves

and their infants. In order to avoid this situation, all women should be strongly

advised to receive their result at the same visit. HIV test results should never be

given telephonically. Women must be post test counselled after receiving the

result of their HIV test. For HIV negative women this will be a brief session

aimed at behaviour modification to reduce risk of HIV infection. For HIV positive

women, post test counseling is not confined to the session after receiving their

result - conselling and support is ongoing, and is particularly important for

adherence to therapy.

1.1.2 Counsellors

The quality of counselling can be improved by strengthening the system. More

lay counsellors need to be trained and employed in antenatal clinics. Existing

counselors should receive regular refresher courses and a mechanism of

psychological support for counselors needs to be put in place. A standard

remuneration structure for lay counselors should be established and the

remuneration process needs to be streamlined.

1.2 ARV IN PREGNANCY AND POSTPARTUM / HIV POSITIVE PREGNANT

WOMEN

The seroprevalence of HIV infection amongst women in the reproductive age

group is variable by province throughout the country, and has only been

established amongst the ante-natal attendees in sentinel site surveys. The

comprehensive operational plan for HIV/AIDS care, treatment and management

should ensure that

i) the great majority of the population who are currently not infected with

HIV remain uninfected;

ii) that availability and access to post exposure prophylaxis (PEP) for

women who suffer sexual violence must be improved.

iii) widespread coverage of contraception and family planning services, such

that pregnancies occuring in HIV infected women should be planned, and

not accidental,

iv) women diagnosed of HIV infection during early pregnancy should be

offered the option of termination of pregnancy, (access to and the

availability of such services should be improved),

v) enhanced efforts in the prophylaxis and treatment of opportunistic

infections, improved nutrition and lifestyle choices be put into place

vi) effective management by suitable palliative and terminal care of those

HIV infected individuals who have developed AIDS defining illness and

where treatment has run its course.

1.2.1 Care of Pregnant Women

Further significant reductions in mother-to-child transmission can be made by

strengthening the provision of the package of prenatal HIV counseling and

testing in antenatal structures, ensuring that appropriate measures are taken

predelivery, during labour and the immediate post delivery and by improving

access to infant formula feeds. In making available appropriate ARV regimen

as indicated by the clinical condition of the women should be instituted.

1.2.2 General Measures

i) Offer VCT and detailed information about testing and results and the

options in respect of these to all women at point of first contact.

ii) Provide detailed information on safe sexual practices, early presentation in

circumstances of medical and obstetric problems to all women.

iii) Ensure universal precautions against vertical transmission during

pregnancy, labour, delivery of the baby and in the puerperium.

iv) Encourage contraception, in particular the access and availability of

barrier methods. Women particularly those above 35 years and parity 5 or

more, should be fully informed about tubal ligation.

v) Ensure screening for STI’s (always do a RPR and in those with a history

of vaginal discharge or who have a discharge present on speculum

examination, take microbiology and treat syndromically) a Pap smear.

vi) Encourage adherence to iron, folic acid and multivitamin preparations, and

information about “healthy eating habits”

vii) Perform routine antenatal blood investigations, history taking and

examination. Remember to enquire about TB in the past or positive

contact.

viii) The offer and provision of appropriate contraception for women living with

HIV should be an integral part of their care. Contraceptive choices will

have to take into consideration the potential interactions with antiretroviral

treatment.

ix) The prevention of new infections in women remains an important goal of

South Africa’s HIV AIDS management. Antenatal care and gynaecological

service provide and important opportunity counseling and testing, and risk

reduction education activities.

1.2.3 Principles of ARVs in Pregnancy

i) The eligibility criteria for pregnant women to start antiretroviral treatment

should be similar to those in non-pregnant adults, but consideration should

be given to any potential effects on the fetus.

ii) The selection of antiretroviral drugs should take into account the special

circumstances of pregnancy. Where therapy is indicated, it should

comprise of a combination of 3 drugs. In particular stavudine and

didanosine should not be used together in pregnant women, and the use

of efavirenz should be avoided in pregnancy, due to its potential to cause

fetal abnormalities. Pharmacovigilance will be essential to monitor for any

adverse events associated with the more widespread use of these drugs

in women of childbearing potential.

iii) All pregnant women with a CD4< 200 cells/mm3 should be started on

antiretrovirals after the first trimester. Pregnant women with CD4 counts

between 200 and 350 CD4 cells/mm3 should be strongly considered for

initiation of antiretroviral therapy after the first trimester, with therapy to be

continued for life.

iv) Nutritional supplements, pneumonia prophylaxis (with co-trimoxazole)

and INH (isoniazide) prophylaxis against tuberculosis should be included

in the enhanced care package.

1.2.4 Evaluation of pregnant women with HIV infection

The following provide a checklist to facilitate evaluation and decision for provision

of ARV.

i) provide standard clinical evauation - HIV disease stage

ii) evaluate degree of immunodeficiency - CD 4 count

iii) document history of prior or current ARV use

iv) assess goal of ARV therapy - maternal health versus PMTCT

v) discuss known and unknown risks and benefits of ARV in pregnancy

vi) develop strategy for long term evaluation and management of mother

and infant

1.2.5 Specific scenarios:

1.2.5.1 Women already receiving highly active antiretroviral treatment

(HAART)

Those women who are treated with antiretroviral drugs before becoming

pregnant, should continue on their medication, even in the first trimester. A

second trimester fetal anomaly scan is usually reassuring. Where indicated,

invasive procedures such as amniocentesis may be considered. If the woman is

receiving efivarenz, this should be discontinued, and replaced with nevirapine

as part of the combination therapy. Women receiving prophylactic medication

(eg against TB, and PCP) should continue these in pregnancy Monitoring will

follow guidelines set out as for adult management. Because of viral suppression

achieved by combination therapy, there is no need for additional medication to

reduce vertical transmission during delivery.

1.2.5.2 Women not on antiretroviral therapy / antiretroviral naïve

For the majority of women who learn of their HIV status during antenatal care, a

decision has to be made whether there is maternal indication for initiation of

therapy, or antiretroviral treatment is used for the sole purpose of reducing

vertical transmission.

i) Initiation of therapy for maternal benefit will follow the same

guidelines as for adult women who are not pregnant – CD4< /= 200

cells/mm3 or clinical stage 4 (AIDS defining illness). Same routine will be

followed as amongst adults regarding education and counselling towards

treatment readiness. (argument to start therapy at a higher CD4 during

pregnancy is not supported since CD4 tend to show a slight decline

anyway during pregnancy, and pregnant women by argument will be

started on treatment earlier than if not pregnant). Treatment should be

initiated after the end of the first trimester. In select cases where mothers

book in the first trimester with a very low CD 4 counts (<50 cells/mm3),

early initiation of treatment could be considered after discussion with the

mother.

ii) Where reduction of vertical transmission is the goal – (in a mother

who has no clinical / laboratory indication for initiation of triple therapy),

women should be managed according to the existing programme which

includes the two dose administration of nevirapine to the mother during

labour and neonate within 72 hours. In the event that nevirapine cannot be

used, other short course regimen should be utilized.

1.2.5.3 Unbooked women:

Majority who fall in this category will not have received any medical attention in

the recent past, therefore with unknown HIV status

Women presenting unbooked for the first time during labour should receive

pretest counselling. If they test positive, baby should receive 2 doses of

nevirapine – one given immediately following delivery, and second within 48

hours. Post-test counseling to the mother can be delayed until after the delivery

process. Assessment regarding maternal indication for ARV should be made

postpartum, bearing in mind the possibility of poor compliance in women who do

not present for free antenatal care.

7.2.5.4 Delivery

All women should be delivered vaginally where possible, with caesarean section

reserved for known obstetric indications Universal precautions and modified

obstetric practices shown to reduce intrapartum transmission should be

observed. In the event of a caesarean section, prophylactic antibiotics should be

administered to reduce the risk of postpartum sepsis (there is no evidence in the

literature that the same should be implemented in women undergoing vaginal

delivery).

1.2.5.5 Post delivery

Signs of infection should be observed before discharge, and arrangement for

follow-up within the next 1 – 2 weeks made to exclude this. Women who are not

on antiretroviral therapy should be reviewed at 6 weeks for clinical staging, and

repeat CD4 count to determine indications for initiation of antiretroviral therapy,

after which they are referred to the general adult clinic

1.3 ARV and Breastfeeding.

Postpartum1. Rational for staging in 6 weeks and not earlier not clear. WHO recommends

initiation of treatment as soon as possible including the postpartum period2. HIV-positive postpartum women with CD4 count > 350 should be followed up

according to current guidelines. Guidelines need to be developed for postpartum women on HAART

3. Newly diagnosed women would need to be diagnosed much faster4. Unbooked woman HIV positive with CD4 count >350 in pregnancy refer for follow-

up5. Consider adopting WHO follow-up schedule of 6 hours, 6 days and 6 weeks

recommended – needs to be coordinated with PMTCT follow-up schedule6. Site for receiving HAART – easy if one site, if other sites may be a problem

Principle decision of where to look after the patients still to be taken e.g. KZN ARV clinic currently not universal

1.3.1 Postnatal HIV transmission

It is well known that HIV is excreted in breast milk. In breastfed infants there is

an ongoing risk of mother to child transmission of HIV via breastmilk for the

duration of breastfeeding. This is probably highest in the first 6 months but there

is an ongoing risk after six months of age of between 3.2 and 6.9 new infections

per 100 child years of breastfeeding1. In developed countries almost all HIV

infected women formula feed their infants. In South Africa exclusive formula

feeding may not always be possible. Women living in informal settlements and

rural areas frequently do not have adequate facilities for safe reconstitution of

formula feeds. A second consideration is the loss of the immunological benefits

of breast milk, particularly in areas where there is a high infant mortality rate from

diarrhoea and other infectious causes. The factor, however, which is probably

more important that any of those above is that of family and community

expectations and fear of stigmatization related to HIV/AIDS. Women may be

expected to at least partially breast-feed their infant and may do so despite the

risks, because of fear of revealing their HIV status. Many women will have

discovered their HIV status for the first time during the pregnancy and may not

yet have disclosed their status to family members.

The exclusive use of formula feeding for infants of HIV positive mothers in

developed countries means that there has been very little experience of the

effect of maternal ARV on the breastfed infant and HIV transmission via

breastmilk.

1.3.2 Factors contributing to breastfeeding transmission of HIV.

i) Maternal viral load: There is some correlation between maternal stage

of disease or viral load and breastfeeding transmission.

ii) Mastitis: several studies have shown that mastitis significantly

increases the amount of HIV excreted in breast milk. This is also true

for other breast conditions such as cracked nipples.

iii) Exclusive breastfeeding vs mixed feeding: One study has shown that

breastfeeding transmission of HIV is lower in women using exclusive

breastfeeding as opposed to those using mixed infant feeding. Further

studies are underway to investigate this finding.

iv) Vitamin A deficiency: The rate of postnatal transmission of HIV is

higher in women who are vitamin A deficient. There is no evidence,

however that vitamin A supplementation reduces transmission at any

stage.

1.3.3 Safety of ARV for breastfeeding infant

Few of the ARV have been studied in lactating women, and for many, little

information is available on breast milk excretion.

ARV Excreted in breast

milk?

Effects on infant

Abacavir Excreted into milk of rats.

No human data.

No data on breastmilk

exposure

ddI Excreted into milk of rats

No human data

No data on breastmilk

exposure

3TC Excreted into human

breastmilk

Well tolerated in

neonates, but clearance

slower than that of older

children

D4T Excreted into milk of rats.

No human data

No data on breastmilk

exposure

Zidovudine Excreted into human

breastmilk

Well tolerated in the

neonate

Efavirenz No human data

Nevirapine Excreted in to human

breastmilk. Median

concentration is 76% of

maternal serum levels.

Potential for skin

reactions, but no

breastmilk exposure

data.

Lopinavir/Ritonavir Excreted into milk of rats.

No human data

1.3.4 General considerations:

All HIV positive pregnant women must receive information about infant feeding

choices during the antenatal period. Each woman needs to understand what

options are available to her and what the pros and cons of each option would be.

She then needs to make an informed choice of infant feeding method best suited

to her own circumstances.

Factors to be taken into account are:

Whether she is currently on ARV

What the stage of her HIV disease is

Her socioeconomic circumstances and ability to obtain (for at least

the first 9 months of the infant’s live) an adequate supply of formula

milk

Her access to facilities to reconstitute the milk safely.

She also needs to consider whether the expectations of her partner

or family are likely to impact on her ability to use a chosen method.

If disclosure has not yet taken place, she must be encouraged to

disclose to a trusted family member who will also be able to support

her in maintaining her chosen feeding method.

1.3.5 Options and important factors to consider:

1.3.5.1 Exclusive formula feeding.

The woman needs to be able to obtain infant formula for at least the first 6

months of the infant’s life. In addition she must have access to facilities for safe

reconstitution of the formula, including a source of clean water and facilities for

the sterilization of bottles. Unicef and the National Department of Health

recommend cup feeding instead of bottles with teats. Healthcare workers need

to ensure that the woman knows how to make up the infant feeds before

discharge home after delivery. The impact of family expectations need to be

taken into account and if there are likely to be questions as to why the woman is

not breastfeeding, she should decide beforehand what she will tell her

family/friends.

Where a woman has chosen to formula feed, healthcare workers need to assist

her and support her with strategies to enable her to continue using the method.

1.3.5.2 Exclusive breastfeeding with or without early weaning.

The concept of exclusive breastfeeding needs to be understood by the mother –

the infant is to receive only breastmilk and no other food or fluids (not even

water). The only other substances which the infant may consume by mouth are

medicines.

The woman needs to be counseled regarding good breastfeeding techniques and

methods to maintain adequate production of breastmilk. Weaning should

preferably take place at 3 or 4 months of age and must occur abruptly with no

period of mixed feeding. If early weaning is to take place, the woman needs to

be able to obtain suitable infant foods. Other factors to be considered are

whether there will be family or community expectations for the infant to receive

additional foods which are traditionally given, and how the mother will deal with

these expectations.

1.3.5.3 Wet Nursing

The HIV status of the wet-nurse needs to be considered as well as the fact that

even if she is HIV negative initially, it is possible for her to become infected

during the period of wet-nursing and HIV seroconversion while breastfeeding is

associated with rates of transmission to the infant as high as 29%. The response

of the family and community to such an arrangement also needs to be

considered.

1.3.5.4 Heat treatment of expressed breast milk

Pasteurisation of expressed breast milk has been shown to effectively inactivate

HIV in the milk. The method has been effectively implemented in an institutional

setting for the feeding of preterm neonates born to HIV positive mothers. The

feasibility of use of the method in a domestic setting after discharge from hospital

has not yet been assessed and for this reason, the method cannot yet be

recommended as an option on a wide scale.

HIV positive women who choose to breastfeed, whether using ARV or not should

be advised and assisted with a number of general measures which can affect

breastmilk transmission;

i) Maternal nutrition – Advice should be given on nutrition and where

necessary additional nutrition supplied. The mother should be on a

multivitamin supplement which includes vitamin A.

ii) Protected sex – the mother should continue to use condoms in order

not to unnecessarily increase her viral load by repeated re-exposure.

iii) Breast-care – correct breastfeeding technique to avoid mastitis or

damaged nipples. If a breast problem arises, it is to be treated

promptly and do not feed from affected breast until the problem has

resolved.

1.3.5.5 Antiretroviral use during lactation

i) Scenario 1: Woman who is on ARV for her own health

For the woman who meets the eligibility criteria for ARV therapy, this

should be commenced whether during pregnancy or in the postpartum

period.

After delivery, the woman should be on the regimen which is the best for

her health.

Infant feeding should be changed to suit the woman’s ARV needs and not

the other way around. Maternal survival influences infant survival, thus

maternal ARV is beneficial to the infant.

Because the effect on infants of breast-milk exposure to ARV is not

known, the general recommendation is that women on ARV should

formula feed if possible. Concerns for the infant would be side effects

from breast milk consumption of ARV, drug interactions between ARV and

other medications which the infant may receive, and transmission of

resistant virus to the infant if mother has treatment failure. There is no

data on what the effect of low doses of ARV will have on infants that have

been infected perinatally – there is a theoretical possibility that it could

lead to resistance, thereby making ARV therapy ineffective for the child.

The woman on ARV should be advised to use exclusive formula feeding

where possible.

If breastfeeding is not avoidable, the infant should be assessed at each

visit for possible side effects of the ARV.

Where medication is prescribed to the infant, care needs to be taken to

review whether there is a known interaction between the medication and

any of the ARV to which he/she is exposed.

ii) Scenario 2: ARV for reduction of postnatal MTCT.

ARV to infants during breast feeding to reduce breastfeeding transmission

Studies of ARV as post exposure prophylaxis to infants up to six weeks of life

indicate some reduction in perinatal transmission. Data on the effect of

continuing courses of ARV for the duration of breastfeeding are very limited. The

potential adverse effects of ARV on the infant need to be considered as well as

the effect it will have on the child’s options for treatment, should he or she

become infected despite ARV prophylaxis. In the absence of any evidence of

clear benefit and concerns about safety, there is currently no indication for the

administration of ARV to infants to reduce postnatal transmission of HIV. This

recommendation will be reviewed as further information becomes available.

iii) ARV to mothers during breastfeeding to reduce breastfeeding

transmission

Theoretically the use of ARV by mothers during breastfeeding will reduce

breastfeeding transmission by reducing maternal viral load, but there is no

clinical evidence to support this. Use of ARV for the purpose of reducing

breastfeeding transmission may affect the effectiveness of ARV therapy for the

mother later. If breastfeeding transmission occurs despite ARV therapy, there is

a risk of transmission of resistant virus to infant. ARV also have potentially

serious side effects for mother, and adherence may be particularly difficult when

the therapy is not directly benefiting the woman. There is no place for ARV

administration to the mother solely for reducing breastfeeding

transmission.

1.4 HIV and TB in Pregnancy

Globally tuberculosis is the most important opportunistic infection complicating

HIV.1 Among communicable diseases, tuberculosis is the second leading cause

of death worldwide, killing nearly 2 million people each year 2 It is the leading

cause of death in HIV-infected individuals.3

1.4.1 Interaction between HIV, TB and Pregnancy

In the general population the interaction between TB and HIV infection is bi-

directional. HIV is the most potent known risk factor for the reactivation of latent

TB.4 HIV also increases the risk of developing symptomatic primary TB infection.

The patient’s defense against the progression of TB infection to active disease is

compromised proportional to the degree of immunosuppression related to HIV.5

With immunosuppression, the clinical and radiological features of TB may be

altered. These include a delayed hypersensitivity response resulting in false-

negative tuberculin skin tests. There is also more involvement of extrapulmonary

sites of TB disease in these infected with HIV especially if the CD4+ cell count is

very low.

On the other hand, there is also evidence that TB affects the course of HIV

infection by enhancing its replication, which, in turn, results in a higher risk of

other opportunistic infections other than TB.

The lifetime risk of developing TB in HIV-negative individuals is 5-10%, and 50%

in HIV-infected individuals6. In other words, an individual infected with HIV has

10 times increased risk of developing TB compared to an individual who is not

infected with HIV.

The outcome of pregnancy is not altered in pregnant women on anti-tuberculosis

drugs. Maternal TB and HIV coinfection increases the risk of the baby acquiring

congenital TB infection. It has been presumed in the past that congenital TB was

rare, however, there is now evidence suggesting that congenital or newborn TB

is an underestimated emergent disease. 7,8,9 The caseload of culture confirmed

cases of TB in neonates and young infants increase by about two-fold when the

pregnant mother is infected by both HIV and TB

1.4.2 Diagnosis of TB in pregnancy

TB attributable to HIV in pregnancy is about 70%, which is very high.10 In those

areas where the prevalence of TB and HIV are high, efforts to improve maternal

health must include detection of TB in pregnancy. However, the diagnosis of TB

in pregnancy is usually difficult and delayed. 11 This is because the symptoms

may be confused with pregnancy symptoms by both the patient and the health

care worker. It may also be due to the fact that extra-pulmonary TB is more

common in HIV-infected individuals, both pregnant and non-pregnant ones.

Diagnosis of TB, according to the NTCP guidelines, should be confirmed by

microscopic examination of sputa. When the sputum is smear positive, it

suggests that the patient has an infectious TB and should be started on anti-TB

therapy without delay.

1.4.3 Treatment of TB in HIV-infected Pregnancy woman

The use of anti-TB drugs and anti-retrovirals in pregnancy is complicated by the

drug-drug interactions between these two groups of drugs as well as their

potential teratogenicty. The following clinical management issues should be

considered:

Efavirenz, (EFZ) an antiretroviral drug, is contraindicated in pregnancy,

especially during the first trimester, because of its potential for birth defects of the

Streptomycin, an anti-TB drug is contraindicated in pregnancy because it can

cause permanent deafness to the unborn baby

Nevirapine (NVP) and Rifampicin should not be used together, because

rifampicin is a potent inducer of liver enzymes (cytochrome P450 3A4) These

enzymes reduce the expose to NVP by 31% and unfortunately dose adjustments

for NVP coadministered with Rifampicin have not been established.

There is also a concern about the hepatotoxicity of both the NVP and anti-TB

drugs when used together.

Nevirapine, therefore, is not used in patients receiving a rifampicin

-based anti-TB regimen.

TB treatment with DOTS should be initiated immediately in a pregnant woman,

irrespective of whether she is on antiretroviral or not.

If a pregnant woman receives both the anti-TB treatment as well as antiretroviral,

all drugs should be reviewed for potential drug interactions and safety in

pregnancy.

The WHO recommended first line regimen for a pregnant woman receiving both

anti-TB drugs as well as antiretroviral is (AZT or d4T) + 3TC + SQV

1.4.4 Scenarios

1.4.4.1 Patients who become pregnant while on TB treatment

Not receiving ARV’s and not eligible for them

Must complete TB therapy like non- HIV infected patients

Monitor patient and start ARV’s when indicated

Monitor patient and start ARV’s when indicated

1.4.4.2 Not receiving ARV’s but eligible

Must complete TB therapy

Start ARV’s using the recommended regimen. Prevention of MTCT must be

taken into consideration when choosing a regimen.

Consider all drugs used for their safety in pregnancy and for drug-interactions

1.4.4.3 Receiving ARV’s

Review all medication (TB and HIV) for potential drug interactions and

teratogenicity and manage accordingly

1.4.5 New TB cases during pregnancy

1.4.5.1 No ARV’s and not eligible for ARV’s

Start TB therapy immediately

Follow the NTCP protocol (DOTS)

1.4.5.1 No ARV’s, but eligible

Start TB therapy immediately

Follow NTCP protocol (DOTS)

If CD4 count <50 or if there is extrapulmonary TB, start ARV’s as soon as patient

tolerates TB therapy

If CD4 count 50-200, start ARV’s after two months

1.4.5.2 On ARV’s

Patient must continue using ARV’s, but must start TB therapy immediately.

Review patient’s HIV treatment. If a patient is on nevirapine, change to SQV

provided there is no contraindication.

Follow NTCP protocol (DOTS)

1.4.6 Patient requiring re-treatment (failure, relapse or return after default)

1.4.6.1 No ARV’s and not eligible for ARV’s

Start TB therapy immediately (Retreatment option)

Streptomycin must not be used in pregnancy

Follow the NTCP protocol (DOTS)

1.4.6.2 No ARV’s, but eligible

Start TB therapy immediately (Retreatment option)

Follow NTCP protocol (DOTS)

Start ARV’s as soon as patient tolerates TB therapy

Streptomycin must not be used in pregnancy

1.4.6.3 On ARV’s

Patient must continue using ARV’s, but must start TB therapy immediately.

Review patient’s HIV treatment. If a patient is on nevirapine, change to SQV

provided there is no contraindication.

Follow NTCP protocol (DOTS) for retreatment

Streptomycin must not be used in pregnancy

1.4.7 Multi-Drug Resistance TB (MDR-TB) in Pregnancy

MDR-TB refers to TB, which is resistant to at least INH and Rifampicin. Currently

the cure rate of MDR-TB patients is less than 50% in the general population in

our country. Treating all TB patients adequately with appropriate TB regimens

can prevent resistance.

Suspect MDR-TB when:

Retreatment patients remain sputum smear positive after three months of

therapy

Close contacts of MDR-TB cases

Treatment failure and interruption cases

Diagnosis can only be done by TB culture and susceptibility testing

1.4.7.1 Treatment

Treat according to guidelines for management of MDR-TB patients in SA. It must

be based on the medication history as well as susceptibility results.

1.4.8 Latent TB

Latent TB or infection with M.Tuberculosis without an active disease. Because of

the high incidence of progression of latent TB to active TB in HIV-infected

individuals, WHO recommends preventive therapy for latent TB with INH.

Currently the preventive therapy is not given widely as part of the NTCP.

1.7 ETHICS GUIDELINES: PREGNANT HIV INFECTED PATIENTS

REQUIRING EMERGENCY MEDICAL AND / OR SURGICAL INTERVENTIONS

It is important to bear in mind that with HIV disease, the unpredictable and

episodic course of the illness makes it difficult to estimate exact prognosis.

However, when treating these women, the clinician must be able to recognise the

point at which quality of life is more important than quantity and hence change

the course of treatment from aggressive curative care to palliative management.

The availability of antiretrovirals must not be allowed to obscure this point and

interfere with sound medical judgement. This has particular bearing in poorly

resourced settings where acute emergency situations are common and

antiretroviral treatments scarce or not available. Moreover, currently, there is no

conclusive evidence that the initiation of antiretroviral treatment during an acute

emergency results in an improvement in the course of recovery from the

emergency. Accordingly, at present antiretroviral treatment should not be

commenced during an acute emergency. However, this does not preclude

institution of antiretroviral treatment where appropriate once the patient recovers

from the emergency. All health care provision must take into consideration the

principles of respect for persons, acting in the best interests of the patient,

minimising harm and fair and justified treatment. Health professionals are

reminded that although HIV / AIDS is incurable at present, it is considered a

chronic condition which is manageable despite being life-threatening.

These guidelines are specific to the critically ill HIV infected patient requiring

emergency medical and / or surgical care. The scope does not extend to cover

the asymptomatic patient who requires a caesarean section as standard obstetric

management.

1.7.1 Definitions:

i) Emergency: a sudden catastrophe calling for immediate treatment that is

necessary and available to avert harm.

ii) Terminal illness: an illness, injury, or other physical or mental condition

that-

(a) in reasonable medical judgement, will inevitably cause the death of the

patient concerned; or

(b) causes a persistent and irreversible vegetative condition with the result

that no meaningful existence is possible for the patient

The diagnosis of terminal illness must be made by at least two health

professionals.

ii) Terminal state: has a corresponding meaning as terminal illness.

iv) Intractable and unbearable illness: an illness, injury or other physical or

mental condition, but excluding terminal illness, that-

(a) offers no reasonable prospect of being cured; and

(b) causes severe physical or mental suffering of a nature and degree not

reasonable of being endured

v) Palliative care: treatment and care with the object of relieving physical,

emotional and psychosocial suffering, in addition to providing basic needs.

1.7.2 GUIDELINES

i)

All decisions regarding medical and surgical procedures will have to

satisfy the ethical and legal requirements of informed consent and the

medical criteria with regards to the patient’s ability to withstand medical or

surgical interventions

Health professionals managing these pregnant women are reminded that

the pregnant women’s life is of paramount importance and takes

precedence over that of the fetus.

Any deviations from standard management should only occur if

determined to be in the patient’s best interests.

ii) Symptomatic HIV+ patient requiring emergency care where CD4 count is

available –

Where the condition is not terminal, proceed with standard, appropriate

management for the particular emergency.

Where the patient has terminal disease, palliative care should be

instituted as first-line treatment.

Where condition is perceived to be, but not conclusive of terminal

disease, institute resuscitation. If, in reasonable medical judgement,

there is no response, a diagnosis of terminal disease should be made,

and the management should be changed to palliative care.

Where the condition is intractable and unbearable, proceed with

management as in bullet 3 above.

iii) Symptomatic HIV+ patient requiring emergency care where CD4 count is

not available –

Institute resuscitation.

Perform standard blood tests including CD4 counts. Manage according

to section 1 once blood results available.

(The HPCSA cautions HCWs that HIV diagnosis without further

examination such as CD4 and viral load, provides no information about

prognosis and actual state of health and unilateral decisions not to

resuscitate these patients could result in disciplinary action. It therefore

follows that withholding or withdrawing of treatment should only occur

once a definitive diagnosis of terminal disease is made.)

iv) Where the patient is not in a position to make an informed decision and

proxy consent is unavailable, the health professional should institute

emergency management in accordance to the institution’s management

procedures. The following criteria must be satisfied where treatment is

initiated without informed consent:

There is a real emergency;

The patient is unable to communicate;

The treatment is not against the patient’s prior wishes; and

The treatment is in the best interests of the patient.

v) Any decision regarding peri-mortem delivery will have to take into

consideration the patient’s prior wishes or be made in consultation with the

patient’s family. The decision will be made by a health professional after

consultation with a colleague. This applies only for the perimortem

delivery in an emergency situation.

vi) For further advice on the ethical issues pertaining to the management of

the HIV infected patient from a woman’s health perspective, contact the

National Department of Health at this number ……… .

ANNEXURES

SCHEMA 1: PT ON ARV

ARV + Pregnancy

Review medication - if 3TC, d4T, NVP , change d4T and

Add AZT

- do baseline CD4

- monitor as per adult protocol

Term: - do viral loads

- delivery - according to obstetric indications

Postdelivery - watch for sepsis

- contraception

- - baby - if maternal viral load was

>1000 at term- give NVP (2mg / kg body weight within 24 to 72 hrs)

- continue same regimen until 6

weeks, and consider changing to Std adult therapy at 6 weeks

SCHEMA 2 = ARV naïve (Tshidi c

- VCT - (-)ve - posttest counselling, promote condom use, screen for STI's,

contraception including condoms postdelivery

- (+)ve - CD 4 count, clinical staging, pap, screen for STI's,

supplements(iron, folate and MVT)

>200 <200

stages 1 / 2 stages 3 or 4

ARV (3TC, NVP, AZT)

NVP at 28 weeks baseline FBC, LFT and U&E

PCP proph(bactrim),

exclude TB, and if -ve, INH proph

monitor FBC, LFT, U&E monthly

CD4 and viral loads at 3 or 6

months

Viral loads at term

Delivery - NVD delivery - NVD,

Modified obs practices modified obs practices

C/s for obstetric reasons C/s for obst indications, with

with proph antibiotics proph antibiotics

Baby=NVP within 48-72 hrs

- baby - if maternal viral at term >1000, give NVP syrup (2mg/kg within 24

to 72 hrs)

*because of slight decline of CD4 in pregnancy, these to be repeated in all

women postdelivery, esp those not on ARV

SCHEMA 3; patient received single dose NVP in previous pregnancy (,12

months)

Take blood for resistance testing

No resistance Resistance

Stage 1/2, CD4 >200

CD 4 >200 CD4 <200

Stages 1/2 stages 3/4

NVP AZT/ 3TC HAART- substitute

NVP

For rotinavir

Monitor as usual