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 pretest 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. All pregnant women with a CD4< 200 cells/mm 3 should be started on iii) 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 Postpartum 1. Rational for staging in 6 weeks and not earlier not clear. WHO recommends initiation of treatment as soon as possible including the postpartum period 2. 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 faster 4. Unbooked woman HIV positive with CD4 count >350 in pregnancy refer for followup 5. Consider adopting WHO follow-up schedule of 6 hours, 6 days and 6 weeks recommended – needs to be coordinated with PMTCT follow-up schedule 6. 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 ARV and Breastfeeding. 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 Effects on infant milk? Abacavir ddI 3TC Excreted into milk of rats. No data on breastmilk No human data. exposure Excreted into milk of rats No data on breastmilk No human data exposure Excreted into breastmilk human Well tolerated in neonates, but clearance slower than that of older children D4T Excreted into milk of rats. No data on breastmilk No human data Zidovudine Excreted into breastmilk exposure human Well tolerated the neonate Efavirenz No human data Nevirapine Excreted in to human Potential breastmilk. in Median reactions, for but skin no concentration is 76% of breastmilk maternal serum levels. Lopinavir/Ritonavir exposure data. 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 bidirectional. 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 falsenegative 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) iv) Terminal state: has a corresponding meaning as terminal illness. 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: v) 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. 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 stages 1 / 2 <200 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 to 72 hrs) term >1000, give NVP syrup (2mg/kg within 24 *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 Stages 1/2 NVP AZT/ 3TC CD4 <200 stages 3/4 HAART- substitute NVP For rotinavir Monitor as usual