PEP Guidelines: Quick-Reference
Table 2. Recommendations for PEP
NOTE: PEP is not recommended for any exposure when source is from a low prevalence population* or, where source is taking HIV pre-exposure prophylaxis (PrEP).
Table Definitions
3 drug: three-drug PEP recommended
2 drug: two-drug PEP recommended
NR: PEP not recommended
| Estimated risk of HIV transmission/exposure*Source A known HIV positive (Refer to tables in Appendix A) | Source of unknown HIV status (Refer to tables in Appendix A) |
|||
|---|---|---|---|---|
| HIV VL unknown or detectable | HIV VL undetectable | Very high prevalence population B (MSM who injects drugs) | High prevalence population B (MSM or from HPC) | |
| Sexual exposure C,D | ||||
| Receptive anal sex | 3 drug | NR | 3 drug | 2 drug |
| Insertive anal sex Uncircumcised | 3 drug | NR | 3 drug | 2 drug |
| Insertive anal sex Circumcised | 3 drug | NR | 3 drug | NR |
| Receptive vaginal sex | 3 drug | NR | 3 drug | NR |
| Insertive vaginal sex | 3 drug | NR | 3 drugs | NR |
| Fellatio | NR# | NR | NR# | NR# |
| Cunnilingus | NR | NR | NR | NR |
| Semen splash into eye | NR | NR | NR | NR |
| Occupational and other exposuresE | ||||
| Shared injecting equipment | 3 drug | Consider 2 drug | 3 drug | 2 drug |
| Occupational needle-stick injury | 3 drug | Consider 2 drug | 3 drug | NR |
| Mucosal exposure/splash injury to infectious fluids | 3 drugs | NR | 3 drug | NR |
| Human bite E | NR | NR | NR | NR |
| Community needle-stick injury | NR | NR | NR | NR |
MSM: men who have sex with men;
VL : HIV viral load;
* A low prevalence population is defined as a population or specific subgroup of the population with an HIV prevalence below 1% (e.g. men other than MSM, general population of Australia who do not inject drugs).
# Consider two-drug PEP only where receptive fellatio WITH ejaculation AND significant visible oral mucosal trauma, or dental and gum disease.
A The person whose blood or other bodily substance may be a source of HIV exposure.
B ‘Very high’ and ‘high’ prevalence populations are those with a significant likelihood that the source is HIV positive and may be viraemic. In Australia, this is principally MSM who inject drugs, MSM who do not inject drugs, people who inject drugs from high-risk countries especially from central Asia and Eastern Europe (see: The Gap Report 2014 – People Who Inject Drugs) and migrants from areas of high HIV prevalence, particularly sub-Saharan Africa (see: AIDSinfo UNAIDS). Recommendations for PEP have been separated in this version of the guidelines given that in Australian populations, the HIV infection and viraemia rates per 1000 population are estimated to be over 13-fold higher among MSM who inject drugs versus MSM who do not inject drugs: currently 156/1000 compared to 12.0/1000 respectively46-49 (Appendix A, Table 9).
C Sexual exposure assumes no condom use or condom failure. Sexual exposures also include those in female and male sex workers in Australia. Rates of HIV infection and viraemia in these people are similar to the populations they belong to. NOTE: The rates of HIV infection and viraemia in female sex workers in other parts of the world (for example, Southeast Asia) may be significantly higher, and PEP may be considered.
D Co-factors that may influence decision-making following sexual exposures: (a) breaches in the mucosal barrier such as genital ulcer disease and anal or vaginal trauma following sexual assault or first intercourse; (b) multiple episodes of exposure within a short period of time e.g. group sex; (c) a sexually transmissible infection (STI) in either partner.
E Co-factors that may influence decision-making following occupational exposures: (a) deep trauma; (b) bolus of blood injected.
F PEP should only be considered after a bite if: (a) the biter’s saliva or mouth had visible blood, AND (b) there was a high suspicion that the biter was viraemic and not on treatment, AND (c) the bite has resulted in severe, deep or multiple tissue injuries.
Figure 1: Recommended regimens for PEP
STANDARD REGIMEN Two-drug regimen: Tenofovir disoproxil* /emtricitabine 200 mg 1 tablet orally daily Three-drug regimen: above two-drug regimen PLUS Dolutegravir 50 mg 1 tablet orally daily OR (alternative) Raltegravir 1200 mg (2 X 600 mg tablets orally daily) ALTERNATIVE REGIMEN IN RENAL IMPAIRMENT^ If eGFR < 30 mL/min: seek specialist HIV and renal advice immediately If eGFR = 30-49 mL/min: use the following dosages58 |
Tenofovir disoproxil one tablet orally every 48 hours PLUS Emtricitabine one tablet orally every 48 hours OR lamivudine 150 mg orally daily PLUS (if three-drug PEP indicated) Dolutegravir 50 mg orally daily OR raltegravir 1200 mg orally daily |
NO DOSE ADJUSTMENTS NECESSARY FOR ANY RECOMMENDED REGIMENS IN HEPATIC IMPAIRMENT58 |
* There are four salts of tenofovir disoproxil available with slightly different dosages in combination with emtricitabine which are considered bioequivalent: maleate, phosphate, fumarate and succinate
^eGFR: estimated glomerular filtration rate
eGFR is recommended to be calculated by Cockcroft Gault equation :58 Creatinine Clearance Calculator
^ alternative dosing with emtricitabine oral solution or tenofovir disoproxil granules may be used where available; for dosage guide refer to: Liverpool HIV Drug Interactions checker website.
Table 4. Laboratory assessment of people who are prescribed PEP
| Test | Baseline | Week 4-6i | Week 12 |
|---|---|---|---|
| HIV (HIV Ag/Ab test) a | X | X | X |
| Hepatitis B (HBV) (HBsAg, Anti-HBs and Anti-HBc) b,c | X | X |
|
| Hepatitis C Hepatitis C (HCV) antibody ± HCV RNA Qual PCR d | X X | X | X |
| Chlamydia and gonorrhoea e | X | X | X |
| Syphilis serology f | X | X | X |
| EUC (including eGFR) h | X | See h | |
| Pregnancy test g | X | X |
a 4th generation HIV antigen/antibody combination test
b HBsAg –HBV surface antigen; Anti-HBs – HBV surface antibody; Anti-HBc – HBV core antibody
c See section: Management of possible exposure to other conditions: HBV
d HCV RNA Qual PCR – Qualitative HCV RNA polymerase chain reaction (PCR) – reflex testing by laboratories following positive HCV Ab test should occur at baseline only if history of past HCV; consider PCR at 4-6 weeks for all occupational exposures, for medico-legal purposes including sexual assault, or for percutaneous exposures if source HCV status is positive or unknown
e See section: Management of possible exposure to other conditions: STIs
f Chemiluminescent Microparticle Immunoassay (CMIA) or Enzyme Immunoassay (EIA); if reactive, laboratories generally perform reflex confirmatory testing and Rapid Plasma Reagin (Venereal Disease Research Laboratory) (RPR [VDRL]) staging
gAssess for risk of pregnancy, perform BHCG serology and consider emergency contraception
hRepeat EUC if abnormal at baseline and/or clinically indicated; eGFR should ideally be calculated using the Cockcroft Gault method73
i At a week-4 visit, assess for transition directly to HIV PrEP.
