The German-Austrian recommendations for HIV1-therapy in pregnancy reflect the current international knowledge and the experience of German clinical settings specialized in the treatment of HIV1-positive pregnant women.
Even though all constellations, scenarios and contingencies of a pregnancy can not be considered within the scope of these recommendations, they are designed as scientifically-based guidelines. The most important and most frequent questions and problems which doctors, who treat HIV1-positive expectant mothers are facing, irrespective of whether they are experienced in the care for such pregnancies or not, are covered in these guidelines.
The medical measures recommended in these guidelines are helpful for every health care professional, who advises a HIV1-positive pregnant woman. Therefore these recommendations should be available in every delivery room. In case of obstetric emergencies the tables of these recommendations can be used as emergency plan.
It is also urgently recommended, that an HIV post-exposure prophylactic emergency set be kept in stock by the hospital and that all medical personnel involved is informed about indications and procedures related to HIV post-exposure prophylaxis after occupational HIV1-exposure (e.g. following needle prick or knife injuries to the operating surgeon).
Therapeutic recommendations can never replace extensive experience with patients and their specific problems. Therefore antenatal care of HIV1-positive expectant mothers, considering the many uncertainties associated with pregnancy, should be performed in or in cooperation with specialized centers.
Without any medical measures to prevent mother to child transmission of HIV1 up to 40% of the HIV1-exposed newborn are HIV1-infected. In those cases, where HIV1-status of the pregnant women was known during pregnancy, since 1995 the rate of vertical transmission of HIV1 was reduced to 1-2% in Germany and Austria . This low transmission rate has been achieved by the combination of anti-retroviral therapy of pregnant women, caesarean section scheduled before onset of labour, anti-retroviral post exposition prophylaxis in the newborn and refraining from breast-feeding by the HIV1-infected mother.
All measures necessary for the prevention of vertical HIV1-transmission can only be employed, if the HIV infection status of the expectant mother is known. Risk factors for an HIV-infection, such as origin from a an HIV epidemic region, current or previous intravenous drug abuse or sexual intercourse with an HIV-infected partner, can not always be identified amongst all pregnant HIV1-infected individuals. For that reason an HIV antibody test should be offered to every pregnant women together with competent personal counseling in regard to possible consequences in the case of a positive test result (see also in 2007 updated German prenatal care guidelines und the therefore created leaflet "HIV-testing in pregnancy" as information of all pregnant women). If necessary this must be carried out with an interpreter and cultural mediation, even if the patient needs to be referred to a specialized center for this purpose. By German law the explicit approval of the pregnant mother is required for HIV-testing, which routinely consists of an ELISA screening test. A positive test result must be confirmed by Western Blot [1, 2]. If the patient is counseled by her gynecologist alone, addresses and telephone numbers of additional experts should be made available to the expectant mother. The personal and medical consequences of any positive test result for the woman should also be discussed in the counseling. Furthermore a competent pediatrician should contribute to the counseling about transmission risks, follow-up tests and the course of HIV1-infection in a child.
As with many other problems in pregnancy, the welfare of the child must be weighed up against that of the mother when deciding for therapeutic/prophylactic measures against HIV1.
The goals of interdisciplinary co-operation between general practitioners, obstetricians and pediatricians in the treatment of HIV1-infected expectant mothers and HIV1-exposed newborns are: 1) the prevention of mother to child transmission of HIV, and 2) the optimal treatment of pregnant women combined with minimal adverse effects in the expectant mother and in the unborn child.
Mothers with a high viral load and/or low t-helper cell numbers transmit HIV1 more frequently to their children [3–5], therefore successful therapy of the mother is also beneficial for the child. Risks for the child that might arise from intrauterine exposure to anti-retroviral combination therapies are still uncertain since data regarding pharmacokinetics, pharmacodynamics, embryotoxicity and fetotoxicity of these drugs are lacking [6–13].
Basic and clinical research data suggest multiple risk factors which contribute to vertical HIV1-transmission [3, 4, 14–25]. Combined interventions as described in the following chapters can reduce the HIV1-transmission rate below 2% [16, 26–28].
The recommendations for diagnostic and therapeutic procedures given here are based on published study results wherever these were available. Such study results, however, are not available for all practical problems and questions, so that often clinical experience and expert opinions must be resorted to.
Even if the goal of these recommendations is the optimal treatment of mother and child based on the most recent findings, it should be stressed that the decision for the recommended diagnostic and therapeutic measures ultimately must be made in agreement with the expectant mother. This means that a refusal of a recommended diagnostic and/or therapeutic measure must also be respected, wherever the consent of an expectant mother can not be acquired despite adequate counseling.
After a detailed analysis of data and publications, a number of procedures were developed for specific situations. Most common situations and scenarios were considered. For all other situations however, individual decision on a case-by-case basis are necessary.
The following situations were discussed and consensus recommendations were made:
Indication for anti-retroviral treatment and therapeutic regimens during pregnancy
2.1 Indication for anti-retroviral treatment
2.2 Resistance testing
2.3. Initial therapeutic regimen
2.4. Management of HIV1-positive pregnant women with Hepatitis-co-infection
2.4.1 Management of HIV1-positive pregnant women with Hepatitis B virus (HBV) co-infection
2.4.2 Management of HIV1-positive pregnant women with Hepatitis C virus (HCV) co-infection
2.5 Interruption of anti-retroviral therapy during the 1st trimester of the pregnancy
HIV1-transmission prophylaxis with standard risk profile
Risk-adapted transmission prophylaxis
4.1 Multiple pregnancy, premature labor and premature infants 33rd(+0) -36th(+6)GW and maternal viral load 3 000-10 000 HIV-copies/ml before birth
4.2 Amnion infection syndrome/amnionitis, (premature) rupture of membranes > 4h, premature birth < 33rd(+0) GW and viral load increase at the end of pregnancy > 10 000HIV copies/ml
4.3. Incision injury of the child/aspiration and/or ingestion of blood contaminated amniotic fluid
Procedures with incomplete transmission prophylaxis
5.1 With verified HIV1-infection
5.2. Situations with unclear HIV1-infection status
Postnatal care in the delivery room
Postnatal prophylaxis of the newborn
Refraining from breast-feeding
Postnatal care of the HIV1-exposed child and preparation of a surveillance register
Phone-Hotline, notification of unexpected observations and experiences
The recommendations were graded as outlined in the German-Austrian guidelines for the anti-retroviral Therapy of HIV1-infection . Unless the results of voting are indicated, the recommendation was agreed upon unanimously.