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Table 1 Grading of the therapeutic recommendations

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

 

I

On the basis of at least one randomized study with clinical end points *

II

On the basis of surrogate marker studies

III

According to expert opinion

A Unambiguous recommendation

A I

A II

A III

B In general advisable

B I

B II

B III

C Justifiable

C I

C II

C III

D In general not recommended

D I

D II

D III

E Unambiguously not recommended

E I

E II

E III

Table 1(Additional). Diagnostic measures during a uncomplicated HIV1 pregnancy

Diagnostic measure

Timepoint/frequency

Reason

 

HIV-screening and if necessary

HIV-confirmative test

-routinely in the 1st trimester in case of unknown HIV1-status;

-at the start of the 3rd trimester after negative initial test but continuous risk of infection

Precondition for therapeutic measures to reduce the risk of vertical HIV1-transmission

 

CD4 cell count + viral-load

At least every two months

Monitoring the course of the HIV1-infection; Initiation of ART or switchover of ART in case of therapeutic failure

Control of the efficacy of the (HA)ART to prevent a high HIV1-viral load at birth

 

HIV1-resistance test

1. As early as possible before the onset of prophylaxis

2. In case of virological therapy failure during an ART

3. With detectable viral load towards the end of an HIV1-prophylaxis

4. 2-6 weeks after application of a prepartal NVP ultra-short prophylaxis

1. Exclusion of a primary ZDV resistance [38–41]

2. According to general therapeutic recommendations for optimizing a therapeutic switchover [29]

3. Registration of any possible resistance induction that might have implications for a future therapy [42]

4. Documentation of a potential resistance induction [43, 44]

 

Blood count (Hemoglobin value)

Monthly

Detection of anemia, thrombopenia related to the use of ZDV in particular

 

Oral glucose tolerance test

Between 23rd (+0) and 27th (+6) weeks of gestation

Detection of gestation diabetes

 

Lactate level + liver values + γGT + LDH + lipase

1. At the start of pregnancy

2. After onset of therapy/prophylaxis

3. In case of clinical symptoms

4. Monthly in the third Trimester

Recommended for detecting lactic acidosis (raised incidence in the 3rd trimester).

Discussion of raised lactate and other values in cooperation with clinicians experienced in carrying out and analyzing lactate measurements.

 

pH measurement in the vaginal secretion

Native preparation

Microbiological culture

STD-diagnostics: Chlamydia, gonorrhea, trichomonas, syphilis hepatitis serology

 

Recognition and timely treatment of local co-infections that can increase the risk of HIV1-transmission

 

Toxoplasmosis screening

At the start of a pregnancy as well as in the 2nd and 3rd trimesters

For the diagnosis of a new infection or a toxoplasmosis reactivation

 

Colposcopy, cytological controls for vulvar, vaginal and cervical dysplasias, HPV-testing

Colposcopy, cytological examination and HPV-testing at the start of a pregnancy; If abnormalities are revealed, colposcopic controls and wherever necessary histological clarification (biopsy)

Increased risk of dysplasia with HIV1-infection [37]

 

Measurement nuchal translucency

10th (+6) - 13th (+6) week of gestation

Estimation of the risk of aneuploidy

 

Sonography, at least DEGUM stage 2

19th (+6) - 22nd (+6) week of gestation

Exclusion of malformations

 
  1. * Clinical end point studies for new substances are no longer carried out due to the fact that conditions for licensing by the FDA and the EMEA have changed