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Table 3 3.1 Prevention of maternofetal HIV1-infection during a normal course of pregnancy

From: German-austrian recommendations for HIV1-therapy in pregnancy and in HIV1-exposed newborn - update 2008

Status of

expectant mother:

No ART before pregnancy Therapy indication according to German-Austrian guidelines for the therapy of HIV1-infection (30)

ART before pregnancy

 

Indication:

CD4 > 350/μl and HIV1-RNA < 10 000 HIVcopies/ml

CD4 > 350/μl and HIV1-RNA > 10,000 HIVcopies/ml

A) Clinical disease ategory B + C or B) CD4 < 350/μl

Women is getting pregnant while receiving an anti-retroviral combination therapy

 

Maternal treatment indication

NO

NO

YES

YES

 

Fetal indication for prophylaxis

YES (prophylaxis with standard risk)

YES (prophylaxis with raised maternal transmission risk)

YES

YES

 

Therapy: 1st -13th week of gestation

Resistance testing to exclude primary ZDV resistance

 
 

Invasive prenatal diagnostics only under anti-retroviral therapy/prophylaxis (perform only if absolutely indicated)

 
 

No ART

At least bimonthly monitoring of CD4 + VL

Start of ART in case of urgent maternal treatment indication (see above)

Invasive prenatal diagnostics (strictly indicated !) only under anti-retroviral therapy/prophylaxis

A) Immediate initiation of ART At least bimonthly monitoring of CD4/VL Switch of ART in case of therapeutic failure or

B) Initiation of ART after week 13, depending on the urgency of the maternal treatment indication (see below). At least bimonthly monitoring of CD4 +VL Start of the ART before week 13 in case of urgent maternal treatment indication

A) Interruption of ART if clinical, immunological and virological status of the mother allows (CAVE: Interruption of NNRTI with long half-life !!!)

At least bimonthly monitoring of CD4 and VL

Immediate restart of ART in case of urgent maternal treatment indication or

B) Otherwise continuation of ART, if necessary substitution of efavirenz; substitution of stavudine + didanosine if given in combination At least bimonthly monitoring of CD4 and VL

 

Therapy: 14th -30th week of gestation

  

Beginning/restart of ART e.g. with ZDV + 3TC/ddI + PI/NVP or premedication, if possible without EFV or d4T+ddI,

At least bimonthly monitoring of CD4 and VL,

Change of ART if therapeutic failure occurs

 

Therapy: (28th)/30th- 37th (+0)/37th (+6) week of gestation

A) ZDV (AI) 2 × 250 mg/d p.o. B) HAART (BI) e.g. with ZDV + 3TC + PI/NVP; if possible without EFV or d4T+ddI

HAART e.g. with ZDV + 3TC + PI/NVP if possible without EFV or d4T+ddI

   

37th (+0) - 37th (+6) week of gestation

Primary cesarean section or vaginal delivery, only if viral load < limit of detection shortly before birth and no obstetric risks (for preconditions and special management of vaginal birth see 6.) + 1 mg/kg i.v. ZDV from 3 h before caesarian until separation, during the first hour a doubled loading-dose, i.e. 2 mg/kg no ZDV if d4T is a component of the maternal therapy

 

Newborn with a complication-free birth process

A: ZDV 4 × 2 mg/kg/d p.o. for 2-4 weeks or

B: ZDV 4 × 1,5 mg/kg/d i.v. for 10 days

Refraining from breast-feeding

 

3.2 Prevention of vertical HIV1-transmission in case of pregnancy - and birth complications

Pregnancy

complication:

Complication-free

(multiple) pregnancy and viral load shortly before birth < 3 000 HIV copies/ml

Viral load

shortly before birth 3 000 -10 000 HIV copies/ml

• Premature labor

• premature birth in ≥ 33 rd (+0) -36 th (+6) GW

• AIS/amnionitis

• premature birth < 33 rd (+ 0) GW

Viral load increase at

the end of a pregnancy > 10 000 HIV copies/ml e.g. because of lacking prepartal prophylaxis

HIV1-transmission risk

Normal

Raised

Very high

Measures in the 24 th (+0)- 37 th (+0-6) week of gestation

Mutliple pregnancy: Prophylaxis onset brought forward with ZDV or ART after GW 29(+0) because of the risk of premature birth

 

-Tocolysis,

-if necessary antibiotics

-RDS-prophylaxis

-HAART e.g.: ZDV+

3TC + PI/NVP (if possible no EFV ord4T+ddI)

  

Birth: 37 th (+0)-37 th (+6) week of gestation

(Elective) Primary cesarean section/CS or vaginal delivery (the latter only if viral load < limit of detection shortly before birth and no obstetric risks/for management of vaginal birth see 6.) + 1 mg/kg i.v. ZDV starting 3 h before cesarean until birth, during the first hour a doubled loading-dose, i.e. 2 mg/kg

Only (Elective) CS !!

+ 1 mg/kg i.v. ZDV starting 3 h before cesarean until birth, during the first hour a doubled loading-dose, i.e. 2 mg/kg

If still possible (decision dependent of obstetrical situation) cesarean within 4 h after rupture of membranes

Elective CS

    

+ 1 mg/kgi.v.ZDV from 3 h before cesarean until birth, during the first hour a doubled loading-dose, i.e. 2 mg/kg

Prepartal 1 × 200 mg NVP° in addition to the ongoing ZDV prophylaxis or ART ZDV prophylaxis or ART

Postnatal prophylaxis of the newborn (108):

4 weeks: Dosing with newborns: ZDV 4 × 2 mg/kg/d p.o.

Refraining from breast-feeding

6 weeks:

A) Dosing with newborns + premature babies ≥ 36th (+0) GW: ZDV 4 × 2 mg/kg/d p. o.

B) Dosing with premature babies < 36th(+0)GW(109): 2 × 2 mg/kg/d p.o. (or 2 × 1.5 mg/kg i.v.) Dosing with premature babies > 30th(+0)GW: from 3rd week of life increase to 3 × 2 mg/kg/d p.o. Dosing with premature babies ≤ 30th (+0) GW: from 4th week of life: increase to 3 × 2 mg/kg/d p.o. Refraining from breast-feeding

6 weeks:

ZDV 4 × 2 mg/kg/d (note premature born dosing) + 3TC 2 × 2 mg/kg/d*

A) with successful prenatal NVP application ° a further NVP dose with the newborn (2 mg/kg) at an age of between 48-72 h

B) If NVP° is not given prepartally, two NVP doses (each 2 mg/kg) postnatally to the newborn: 1st Dose as soon as possible after birth, 2nd Dose on the 3rd day of life (cave: because of enzyme induction faster elimination of NVP in the newborn, if NVP was a omponent of the maternal therapy during pregnancy)

Refraining from breast-feeding

Birth complications:

-Incision injury to the child - Oral intake of bloody amniotic fluid into gastrointestinal or respiratory tract of the newborn

HIV1-transmission risk

Very high

Postnatal measures in the newborn:

6 weeks:

ZDV 4 × 2 mg/kg/d (check premature born dosing wherever necessary) + 3TC 2 × 2 mg/kg/d*

Two postnatal NVP doses° (each 2 mg/kg) to the newborn: 1st Dose as soon as possible after birth, 2nd Dose on the 3rd day of life (cave: because of enzyme induction faster elimination of NVP in the newborn, if NVP was a component of the maternal therapy during pregnancy) Refraining from breast-feeding

  1. ZDV, zidovudine; ART, anti-retroviral combination therapy with usually three medications: two nucleosidal reverse transcriptase inhibitors + a protease inhibitor (PI) or nevirapine; 3TC, lamivudine; ddI, didanosine; d4T, stavudine; NVP, nevirapine; EFV, efavirenz; VL, virus load
  2. * Beware: Presently only a few clinical results have been published regarding the application and dosing of lamivudine with (extreme) premature infants.
  3. ° Beware: if the HIV1-positive expectant mother has been treated for a longer period of time with nevirapine during pregnancy, an enzyme induction may occur that may lead to a more rapid breakdown of nevirapine in the newborn.
  4. ZDV, zidovudine; ART, anti-retroviral combination therapy usually with three medications: two nucleoside reverse transcriptase inhibitors + one protease inhibitor (PI) or nevirapine; 3TC, lamivudine; ddI, didanosine; d4T, stavudine; NVP, nevirapine; EFV, efavirenz; AIS, amnion infection syndrome