Post-exposure prophylaxis

HIV post-exposure prophylaxis Recommendations on POSTEXPOSURE PROPHYLAXIS (PEP) for HIV infection at Hannover Medical School

Updated version from 31.10.2022

Clinical Department of Rheumatology and Immunology

Editing: Prof. Dr. Georg Behrens

* The recommendations reflect the current state of knowledge. The dosage recommendations/side effects given are only rough guidelines. They do not release the user from the obligation to carefully determine the indication on the basis of the manufacturer's recommendations and the data in the current literature. Liability claims arising from possibly incomplete or incorrect information in these recommendations are expressly excluded.

Since 1998, several revised national and international recommendations have been published on how to deal with exposure to the HI virus. The current, very detailed consensus on this topic is now available on the DAIG website. We have therefore largely dispensed with our own presentation of the problem and refer to the following link (Guidelines and recommendations on HIV infection and post-exposure prophylaxis):

https://daignet.de/site-content/hiv-leitlinien/leitlinien-1/deutsch-oesterreichische-leitlinien-zur-postexpositionellen-prophylaxe-der-hiv-infektion-1

 

The recommended antiretroviral options include

The following combinations are recommended:

  • Tenofovir-DF/emtricitabine 1x1 + raltegravir 2x400 mg or 1x2 at 600 mg each
  • Tenofovir-DF/emtricitabine 1x1 + dolutegravir 50 mg 1x1
  • Tenfoviralafenamide/emtricitabine/bictarvy* 1x1

If these are not available:

  • Tenofovir-DF/emtricitabine + darunavir/ritonavir 800 /100 mg
  • Tenfoviralafenamide/emtricitabine/elvitegravir/c* [89]

 

From our daily experience in counseling, we would like to list some frequently asked questions (FAQs) here:

 

1st question: What are the risk situations? When should a PEP be considered?

Answer: A PEP should be considered in the following situations in particular: Injury with HIV-contaminated instruments or injection equipment, wetting of open wounds and mucous membranes with HIV-contaminated fluids, unprotected sexual intercourse with an HIV-infected person, use of HIV-contaminated injection equipment and transfusion of HIV-contaminated blood or blood products.

Question 2: How dangerous is exposure to HIV?

Answer: Most of the events mentioned above (under 1.) have a risk in the range of approximately 1:100 to 1:1,000. The average risk of a needlestick injury is best studied and is in the range of approximately three per thousand. It is higher in the case of a large hollow-bore needle visibly contaminated with blood and lower in the case of a needle without a hollow point (e.g. for surgical sutures).

Question 3: Should PEP be carried out for every exposure to HIV?

Answer: No. The recommendation is based on an assessment of the individual risk from the respective event. As a rule of thumb, a risk of significantly less than 1:1,000 no longer justifies PEP.

Question 4: What is the risk if the HIV status is not known?

Answer: In Germany, statistically about one in 1,000 citizens is currently HIV-positive, in Lower Saxony one in 2,000. In the case of a needlestick injury with a freshly blood-contaminated needle of a person with unknown HIV status, the following calculation results for the individual risk ("IR"): ("A"=probability that the person is HIV-positive: approx. 1:1000), ("B"=probability of transmission through the event: [in the case of a needlestick injury with a blood-contaminated needle] approx. 1:300). The risk "IR" is therefore: IR = A x B = 1 : 1,000 x 1 : 300 = 1 : 300,000. Because this risk is very clearly below 1:1,000, PEP should not be recommended.

5th question: Why is PEP not recommended "as a precaution" even in the case of very low risks? Is this perhaps a kind of misunderstood frugality?

Answer: All combinations of PEP available to date can lead to side effects. These can be unpleasant but harmless. The consensus recommendations have weighed up the pros and cons of recommending PEP. If there are no justifications that can be derived from the individual case to assess the individual risk as higher, the recommendations given there should therefore not be deviated from, because the risks of the PEP measure are otherwise potentially higher than not taking it.

6th question: The package insert for the drugs recommended for PEP states that they are only admitted for the treatment of an existing HIV infection. There is no mention of prophylaxis in the product information. As a physician, am I then allowed to prescribe or start PEP at all?

Answer: Yes. The PEP recommendations have the character of a guideline. They are co-authored and published by the specialist societies and also by a federal authority (Robert Koch Institute) and certified by the AWMF.

In 2018, the Federal Joint Committee (GBA) recognized the prescription of HIV PEP as reimbursable if it was well indicated by a specialist. The GBA refers to PEP as post-exposure early "therapy" and not "prophylaxis" - and therefore the indication is no longer "off" label.

In the case of occupational exposure, the costs are borne by the statutory accident insurance providers. In other cases, according to the GBA decision, the costs of PEP as "post-exposure early therapy after HIV exposure" are covered by health insurance if the indication is appropriate(https://www.aerzteblatt.de/nachrichten/93540/Aerzte-begruessen-G-BA-Entscheidung-zur-HIV-Postexpositionsprophylaxe)

Question 7: The so-called "index person" - i.e. the person from whom the suspected risk of transmission emanates - refuses an HIV antibody test, which, as is well known, is subject to a special consent requirement. What can be done?

Answer: Mere assumptions are always highly speculative and should not be used as a basis for initiating PEP.

HIV testing is not required for the indication of PEP. The indication is primarily based on whether

  • an HIV infection is definitely known and, if applicable, additionally
  • an existing HIV infection is being effectively treated with antiretroviral therapy.

 

Local contacts for drug-based post-exposure prophylaxis of HIV exposure

The following contacts are available at the MHH:

  • Clinical Department of Rheumatology and Immunology: Prof. Dr. med. Georg Behrens, Dr. Gerrit Ahrenstorf, Immunology Outpatient Clinic II (Building K14) of the MHH: Tel.: 0511 532-3637, alternatively duty mobile.
  • Department of Pediatric Pneumology: PD Dr. U. Baumann, Tel. 0511 532-3251
  • Department of Gynecology (for special questions in the field of obstetrics, gynecology): Prof. Dr. Dr. C. von Kaysenberg, Tel: 0511 532-6096; 0511 532-6862, 0511 532-6144

Selection of registered HIV-focused physicians in the Hannover area:

  • Dr. H. Heiken, Dr. S. Holm, Dr. B. Kuhlmann, Dr. J. Miehe, Georgstraße practice
  • Dr. C. Zamani, Hanover