This document provides guidelines for the management of occupational exposure to blood and body fluids that may contain the human immunodeficiency virus (HIV), and recommendations for HIV post-exposure prophylaxis (PEP). These guidelines also assess available data on the risk of acquiring HIV infection from occupational exposure, the efficacy of antiviral drugs, recommendations for the management of occupational exposure to blood or body fluids and issues relating to compensation for occupationally acquired HIV infection.
Recommendations for PEP are related to the risk of infection from selected exposures and the HIV status of the exposure source. For high-risk exposures a four-week course of Zidovudine and Lamivudine are recommended. The addition of Indinivir is recommended for selected very high-risk exposures.
The focus of these guidelines is occupational exposure to blood and blood products. Saliva, tears, sweat, urine and breastmilk are not associated with the risk of HIV transmission in an occupational setting.
Advances in the prevention and treatment of HIV and AIDS are progressing at a rapid rate and recommended clinical practice may change over time. This Policy Guide will be regularly reviewed and updated, as new findings become available.
The use of trade names is for identification only and does not imply endorsement by the Department of Health.
1.1 The term ‘health care workers’ refers to all personnel (both professional and non professional) working in health care settings whose activities involve contact with patients or who handle blood products and body fluids.
1.2 An ‘exposure’ is defined as a percutaneous injury, contact with intact skin, contact with non-intact skin (e.g. when the skin is inflamed, chapped or abraded. ‘Body fluids’ include semen, vaginal secretions or other fluids contaminated with visible blood.
1.3 Health care workers, especially those whose work involves: 1) blood collection or the use of sharp instruments such as needles and scalpels; 2) the insertion of intravenous catheters; or, 3) minor and major surgery, are at increased risk of occupational injury and exposure to HIV infected blood. There is also a potential risk to workers handling soiled linen and those involved in handling corpses and performing post mortem examinations.
1.4 The possibility of occupationally acquired HIV infection and the current lack of a definitive cure or vaccine have caused concerns for health care workers.
1.5 The average risk of HIV infection from all types of reported percutaneous exposure to HIV infected blood is 0.3%. Approximately 1 in every 300-330 exposures will result in an established HIV infection in the health care worker.
1.6 The risk of HIV infection following exposure increases if: 1) the injury is deep; 2) there is visible blood on the device causing the injury; 3) the device was previously placed in the source patient’s vein or artery; or, 4) the source patient has advanced HIV disease (AIDS).
1.7 The risk is considered to be higher than 0.3% if the exposure involves a large volume of blood or if the source patient has very high HIV titres in their blood.
1.8 Injuries with solid needles, such as a suturing needle, carry a lower risk than a hollow bored needle.
1.9 The risk of HIV transmission after mucous membrane or skin exposure to HIV infected blood depends on the volume of blood and the titre of HIV in the blood, and is reported to be in the order of 0.1% and less than 0.1% respectively.
1.10 The risk from skin exposure to HIV infected blood is low but increases if: 1) the contact is prolonged; 2) the contact involves an extensive area of skin; 3) the skin is visibly compromised (i.e. has open wounds, diseased, or is inflamed); or, 4) there is a high titre of HIV in the source patient’s blood
1.11 A high HIV titre, or viral load, in the source patient’s blood is often associated with advanced immune deficiency and a low CD4 cell count, the AIDS phase of HIV disease, or early HIV infection. HIV viral titres may also rise during intercurrent infections such as active tuberculosis.
1.12 Transmission of HIV, and other blood borne viruses such as Hepatitis B virus (HBV), is minimised by strict adherence to standard universal precautions and by adoption of procedures to sterilise or disinfect equipment in contact with blood or blood products. Universal precautions require that health care workers treat the blood and body fluids of all persons as potential sources of infection, independent of perceived risk or diagnosis. Compliance with universal precautions will minimise risk or transmission of HIV and HBV.
1.13 A policy for the management of exposure to HBV is available from the Department of Health. This policy includes immunising health care workers against hepatitis B and passive immunisation (immunoglobulin) for non-immune exposed health care workers following an occupational exposure to HBV.
1.14 Health facilities must ensure that health care workers are fully informed about infection risks and that they comply with infection control procedures. This includes: 1) the use of protective equipment (i.e. gloves, and aprons); 2) covering skin lesions, cuts or abrasions with occlusive dressings; and, 3) that equipment in contact with blood and body fluids is appropriately disinfected and sterilised.
2.1 In recent years evidence has demonstrated the efficacy of anti-retroviral drugs in reducing the risk of HIV infection from percutaneous exposure to HIV infected blood. Although failures of post exposure prophylaxis (PEP) with these drugs have occurred, treatment with Zidovudine (ZVD) alone was associated with a 79% reduction in risk for HIV sero-conversion after percutaneous exposure to HIV positive blood. There is also evidence of the efficacy of anti-retroviral agents in reducing the risk of mother-to-child HIV perinatal transmission. The use of ZVD in pregnancy resulted in a 67% reduction in mother to child transmission and recently a shorter course regime has a proven efficacy of reducing perinatal HIV transmission by approximately 50%.
2.2 Recent advances in the understanding of HIV pathogenesis, the determination of plasma HIV titres and the development of anti-retroviral therapeutic agents have revolutionised the approach to the treatment and prevention of HIV infection.
2.3 For HIV infection to occur from percutaneous exposure or sexual transmission, the virus attaches to CD4 receptors on immune cells at the site of injury. Once attached to the surface of these cells, infection may take place. This process takes from several hours to several days to occur and provides a window of opportunity for anti-viral PEP. The sooner that PEP is started, the better the chance of reducing viral replication and enabling the body to eliminate viable virus.
2.4 Every effort should be made to minimise the likelihood of viral replication occurring in the exposed health care provider. This requires rapid assessment of the exposure and initiation of PEP therapy if indicated as soon as possible after the incident with anti-retroviral agents.
2.5 Reverse transcriptase inhibitors (e.g. ZVD, Lamivudine, and Didanosine) interfere with the ability of the virus to infect the target cell. Protease inhibitors (e.g. Indinivir) can suppress viral replication if the cell is already infected.
2.6 Protection with PEP is not absolute and there have been reports of treatment failure. Treatment failure may be related to HIV viral strains that are resistant to drugs used in the source patient. Such resistant strains are more likely in patients who have been on 6-12 months of anti-retroviral therapy and patients who also have low CD4 cell counts. Failure of PEP may also be due to high HIV viral loads in the source patient or if the PEP was initiated too late or for insufficient duration.
3.1 Retrospective studies of health care workers who have received ZVD following an occupational exposure to HIV have shown a reduced risk of sero-conversion. There are no data currently available to directly support the addition of other antiretroviral drugs to ZVD to enhance the effectiveness of the PEP regimen. However, in HIV infected patients, combination regimens have proved superior to monotherapy in reducing viral load. Adding a protease inhibitor (e.g. Indinavir, Saquinavir, or Ritonavir) provides an even greater increase in anti-retroviral activity. There is a possibility of drug resistance in source patients who have already been exposed for long periods to ZDV and Lamivudine. In such cases the addition of a protease inhibitor such as Indinavir may add further efficacy to the PEP regimen.
4.1 The toxicity of anti-retroviral drugs (other than ZVD) in persons not infected with HIV has not been well documented.
4.2 In HIV infected persons the following side effects of anti-retroviral drugs have been noted:
ZVD: headache, gastro-intestinal symptoms (nausea, vomiting, diarrhoea, indigestion). More serious side effects such as marrow suppression with resultant anaemia or pancytopaenia are extremely rare in a healthy individual.
Lamivudine: gastro-enteritis and rarely pancreatitis.
Indinavir: gastro-intestinal symptoms and rarely may cause renal stones.
5.1 If PEP is initiated, the health care worker should be seen and monitored for toxic drug effects by a clinician that ideally has experience in HIV care. Baseline studies should include a full blood count, platelets, renal and hepatic function tests, urea, electrolytes, creatinine and liver function tests. These studies should be repeated if there are any side effects. Muscle enzymes and a serum amylase should also be considered. If toxicity is noted, dose reduction or drug substitution with other appropriate agents should be considered.
5.2 Mild side effects such as headache, and nausea, are often experienced in the first few days after commencing PEP. Serious side effects usually occur after prolonged use and rarely occur within the first 4 weeks of therapy.
2.1 The following are potential exposures that should be considered for PEP
A blood contaminated needle stick injury
An injury with a blood contaminated sharp instrument or similar instruments contaminated with semen, CSF, pleural or other serous fluid (excluding urine and faeces).
An exposure to the mucous membranes (eye, mouth) with the above fluids.
A blood contamination of compromised or diseased skin (such as a weeping eczema).
Prolonged exposure to a large volume of blood on normal skin
2.1 If there is no record of the HIV status of the source patient, then an attempt should be made to obtain blood from the patient for this purpose. This should according to existing guidelines for HIV testing and include pre and post-test counseling. An approved rapid HIV test could be performed and later confirmed by routine HIV testing procedures.
2.2 If the patient refuses HIV testing, if there is no record of a recent HIV test result, or if HIV testing is not possible or available, then a doctor caring for the patient should be consulted as to the likelihood of the patient being HIV positive. Clinical signs indicating possible HIV infection include: TB infection, signs of immune deficiency such as oral thrush (candidiasis) and/or oral hairy cell leukoplakia on the tongue, recent herpes zoster or molluscum contagiosum infection, Kaposi sarcoma, recurrent infectious conditions such as diarrhoeal diseases, pneumonia, meningitis, skin sepsis; or unexplained weight loss, seborrhoeic dermatitis or persistent glandular lymphadenopathy. Using these clinical parameters in the absence of an HIV test is far from ideal and many HIV positive persons will be asymptomatic.
[In situations where there is a high suspicion that the patient may be in the window period, then an HIV PCR or HIV p24 antigen test could be considered.]
3.1 PEP is recommended for any high-risk exposure (see table 1).
3.2 ZVD in combination with Lamivudine is recommended for high risk exposures. Single therapy with ZVD may be effective and is preferable to no PEP but is likely to be less effective than therapy with more than one drug. Single ZVD PEP therapy is not recommended by any recognized international authority.
3.3 Indinavir can be added for very high risk exposures. Very high risk exposures include: 1) large volume of blood; 2) deep injury; and, 3) if the source patient has been on ZVD for more than 6 months.
3.4 PEP should be initiated promptly, preferably within 1-2 hours after the exposure. The interval after which there is no benefit from using PEP is not yet defined, however most experts recommend PEP within 24 hours after exposure. Some experts may still consider PEP 7-14 days after the exposure in cases where there is highest risk exposure. To avoid delays in starting PEP, starter packs of recommended drugs should be available in all health care settings.
3.5 PEP should be continued for 4 weeks. PEP should be discontinued if there are serious toxicities or intolerance and should be continued even in the presence of mild side effects.
3.6 Exposures such as small blood volumes or other body fluid contact on normal healthy skin are considered very low risk. PEP is not recommended in these cases but can be assessed on a case by case basis. For exposures to urine or faeces, PEP is not recommended unless these are contaminated with blood.
3.7 If the source patient’s HIV status is not known, initiating PEP should be decided upon on a case by case basis, and based on circumstances including the likelihood of HIV infection in the source patient.
3.8 PEP is recommended if: 1) the source patient is HIV positive; 2) the rapid HIV test is positive; or, 3) or if there is a high index of suspicion that the source patient is HIV positive.
3.9 An Elisa HIV test should be done and documented on the exposed health care worker at baseline (i.e. within 24 hours of the injury), at 6 weeks, 12 weeks and at 6 months. In rare instances sero-conversion can take place over a period longer than 6 months.
3.10 Tests for occupational exposure to Hepatitis B and C, syphilis, malaria etc should also be considered if deemed appropriate. PCR and p24 antigen tests are not routinely recommended as false positive and negative tests are not infrequent and these tests are costly.
3.11 Supportive counseling should be available to the health care worker. The health care worker should consider using a barrier method for safer sex. Avoidance of pregnancy in female health care workers is also recommended until sero-conversion is excluded. Pregnancy in health care workers should not preclude the use of PEP.
3.12 If HIV sero-conversion occurs the health care worker should be referred for appropriate counseling and treatment and informed about compensation claims (see Appendix 2).
3.13 An appropriate and confidential reporting system should exist within health facilities to document all occupational exposures and details on the source patient, and health care worker for medico-legal purposes and for possible compensation and insurance claims. All HIV related occupational exposures, irrespective of whether PEP is recommended, should be reported to health facilities.
3.14 Health care facilities should delegate responsible officials to oversee the reporting and recording of occupational HIV exposures.
3.15 If the HIV test on the source patient is negative, it can be assumed that there is a low risk of exposure to HIV unless there is reasonable information to suggest that the source patient is in the window period. In these cases PEP is not recommended.
| Percutaneous injury |
Risk of exposure |
Recommendation for PEP |
| Superficial injury, solid needle | Some risk | Consider Basic Regimen |
| Skin puncture, visible blood on the needle, hollow needle, | High risk | Recommend Basic Regimen |
| Needle used in a vein or artery | Highest risk | Recommend Basic Regimen, Consider Expanded Regimen |
| Deep intra-muscular injury or injection into the body | Highest risk | Recommend Basic Regimen, Consider Expanded Regimen |
| Mucousal and skin contacts | Risk of exposure | Recommendation for PEP |
| Unbroken healthy skin | Low risk | Not recommended |
| Compromised skin, small volume and brief contact | Low risk | Consider Basic Regimen |
| Compromised skin, large volume and/or prolonged contact | Increased risk | Recommend Basic Regimen |
| HIV Status of Source | Risk of exposure | Recommendation for PEP |
| Negative | Very Low | Not recommended |
| Positive, Clinical AIDS and/or a low CD4 cell count and /or a high viral load | Low for small volumes or short duration on intact skin | Consider Basic Regimen |
| HIV Positive, Clinical AIDS and/or a low CD4 cell count and /or a high viral load | High risk for percutaneous injuries | Recommend basic or expanded regimen depending on the severity of injury |
| Unknown | Consider PEP on a case by case basis |
| Drug |
Dose |
Frequency |
Duration |
|
Zidovudine (AZT) |
200mg |
8 hourly |
4 weeks |
|
Lamivudine (3TC) |
150mg |
12 hourly |
4 weeks |
For very high risk exposures - Add
| Indinivir |
800mg |
8 hourly |
4 weeks |
Compensation for occupationally acquired HIV infection
The following information is from a series of consultations with the Compensation Commission (formerly known as the Workmen’s Compensation Commission) and other relevant role players on the issue of compensation for occupationally acquired HIV exposure and HIV infection. It must be noted that the final decision as to whether there is a entitlement to compensation for any particular injury will rest with the Compensation Commission and each case will be judged on its own merits and on the facts of the case. It should further be noted that some of the rules and regulations and the approach to assessing compensation may change over time and this policy may therefore need to be updated from time to time.
1.0 Occupationally acquired HIV infection from an injury in the workplace is a compensatable injury.
1.1 It is the duty of the employer to provide for the necessary procedures and costs for the management of occupational HIV exposure in the pre-sero-conversion phase. This may include the HIV tests, the medical consultations, other laboratory tests, post exposure prophylaxis, and counseling.
1.2 The Compensation Commission will consider compensation only from the time of sero-conversion (this may include the HIV test which documented the sero-conversion).
1.3 For compensation purposes, the employee must prove a link between the injury on duty and the HIV infection. For this reason it is important to document the HIV status of the employee and the source patient. Knowledge of the source patient’s HIV status will strengthen the claim. To support an application for compensation for an occupationally acquired HIV infection the employee must demonstrate an HIV negative status at the time of the injury and the source patient should have a documented HIV positive test result.
1.4 In the absence of the source patient’s HIV status, the employer must be able to demonstrate that every effort was taken to assess the HIV status of the source patient and that this was refused by the source patient. Other relevant clinical information on the source patient must also be documented for the claim. A sero-conversion within 3 months of the injury is considered to be reasonable evidence that the sero-conversion was as a result of the injury, provided all other necessary information is provided. If the source patient or the employee is considered to be in the window period then PCR testing should be considered.
1.5 Each claim will be assessed on its merits. Employees and employers should ensure that documentation of occupational exposures are kept on record and that claims are submitted within 11 months from the time of the injury. The CC will provide compensation for reasonable care at reasonable cost for a successful claimant, and any claims for disability will be assessed in the usual manner.
1.6 The CC will not provide compensation for treatment to reduce mother-to-child HIV transmission in cases of occupationally acquired HIV infection in the mother.
Provincial HIV and AIDS Coordinators:
Resources for Consultation
Persons who seek assistance in managing occupational HIV exposures should contact Provincial HIV and AIDS co-ordinators or the National Department of Health HIV and AIDS/STD Directorate
| Postal Address | Physical Address | Telephone | Fax |
| Ms Wanda Mthembu HIV and AIDS & STD Programme Department of Health Private Bag X9051 Pietermartizburg 3200 |
Long Market Street Pietermartizburg 3200 |
0331 - 95-2729 083-457-1172 |
0331 - 42-6744 |
| Dr Victor Mafungo HIV and AIDS & STD Programme Department of Health Private Bag X5049 Kimberley 8301 |
Floor 12 Post Office Building Crn. Knight & Stead Streets Kimberley 8301 Jane Stuurman-Moleleki Koin |
053 - 80-0658 053 - 830-0761 053 - 830-0712 |
053 - 800-6060 053 - 833-3814 |
| Dr MD Masipa HIV and AIDS & STD Programme Department of Health Private Bag X9302 Pietersburg 0700 |
Jan Moolman Building 34 Hans van Rensburg Street Pietersburg 0700 |
015 - 295-2851 X2334 |
015 - 2915961 |
| Ms Sylvia Abrahams Department of Health HIV and AIDS and STD Programme PO Box 2060 Cape Town 8000 |
4 Dorp Street Cape Town 8001 |
021 - 483-4071 483-3458 |
021 - 483-4345 483-2264 |
| Ms Marlene Poolman HIV and AIDS & STD Programme Department of Health Private Bag X0038 Bisho 5608 |
Room 136A Dukumbana Buildings Department of Health Independence Avenue Bisho 5608 |
040 - 609-3907 082-823-8200 |
040 - 635-0072 936-1142 0431-47-3698 |
| Dr Kelvin Billinghurst HIV and AIDS & STD Programme Private Bag X11278 Nelspruit 1200 kelvinb@social.mpu.gov.za |
17 Hope Street Nelspruit 1201 |
013 - 752-8085 X2071 |
013 - 755-3549 755-3546 |
| Dr Vitalis Chipfackacha HIV and AIDS & STD Programme Private Bag X2068 Mmabatho 8681 |
Tirelo Building, Room 2034 Department of Health Opposite UNIBO Mmabatho 8681 |
018 - 387-5227 | 018 - 387-5332 |
| Ms Ntsiki Jolingana HIV and AIDS and STD Programme Department of Health P O Box 517 Bloemfontein 9300 |
5th Floor, Room 537 Lebohang Provincial Building St Andrews Street Bloemfontein 9301 |
057 - 352-1453 X 2219 |
083 305-8768 057- 352-9277 |
| Dr Liz Floyd Director: Communicable Diseases Department of Health Private Bag X085 Marshalltown 2107 |
Floor 18 Bank of Lisbon Building Cnr Sauer and Market Street Johannesburg 2000 |
011- 355-3866 Cell phone 082-372-0552 |
011 - 355-3399 011 - 355-3386 011 - 838-1708 |
National Department of Health HIV and AIDS/STD Directorate: (012) 312-0121