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31st October 2014 No. 26 Occupational Exposure to HIV and Post Exposure Prophylaxis NSY Padayachee Moderator: CS Alphonsus Discipline of Anaesthesiology and Critical Care CONTENTS INTRODUCTION ................................................................................................... 3 OCCUPATIONAL EXPOSURE TO HIV ................................................................ 4 RISK OF OCCUPATIONAL TRANSMISSION TO HIV ......................................... 4 POST EXPOSURE PROPHYLAXIS AND ITS RATIONALE ................................ 7 PEP CONSIDERED ON BASIS OF HIV PATHOGENESIS .................................. 8 PEP EFFICACY IN ANIMAL STUDIES ................................................................ 9 PEP EFFICACY IN HUMAN STUDIES ............................................................... 10 PEP TREATMENT FAILURE .............................................................................. 10 PEP DRUG REGIMENS ..................................................................................... 12 PEP TIMING AND DURATION ........................................................................... 13 ADVERSE EFFECTS, TOXICITY, AND DRUG INTERACTIONS ....................... 14 LEGAL FRAMEWORK OF PEP ......................................................................... 16 PREVENTATIVE STRATEGIES ......................................................................... 16 STEP WISE APPROACH TO AN OCCUPATIONAL EXPOSURE ..................... 18 GENERAL MEASURES ..................................................................................... 18 EVALUATION OF EXPOSURE .......................................................................... 18 TESTING OF THE SOURCE PATIENT .............................................................. 19 REPORTING OF THE EXPOSURE .................................................................... 19 COUNSELLING SUPPORT ................................................................................ 19 ASSESSMENT OF THE HEALTH CARE WORKER .......................................... 20 CONCLUSION .................................................................................................... 21 REFERENCES.................................................................................................... 22 Page 2 of 24 OCCUPATIONAL EXPOSURE TO HIV AND POST EXPOSURE PROPHYLAXIS INTRODUCTION Exposure to the human immunodeficiency virus(HIV) in an occupational setting, creates a small but possible risk of infection(1) . Health care workers(HCW’s) are at increased risk of contracting HIV. This is due to exposure to potentially contaminated bodily fluids in association with inadequate safety precautions(1) . According to the World Health Organisation(WHO), there are 1000 new HIV infections per annum due to occupational exposure which are estimated from 3 million percutaneous injuries among 35 million HCW’s worldwide. More than 90 % of these exposures occur in the resource constrained countries of the developing world(2). The highest incidence of exposure being in sub-Saharan Africa and Asia - 9 exposures/health worker/year(3.4). The actual risk of occupational transmission of HIV is greater than usually reported for the following reasons: (a) suboptimal monitoring and surveillance of occupational exposures in the developing world; (b) higher prevalence of HIV; and (c) inadequate safety precautions and risk reduction strategies(5). In light of the growing HIV and AIDS epidemic, protecting health care workers in developing countries where basic medical care is inadequate, proves to be a formidable challenge. Human resources are depleted due to occupational exposure to HIV. This is not only as a direct result of transmission and related morbidity but also the psychological stressors and anxiety regarding safety and lack of support in preventing the risk(6). Primary preventative strategies should form the mainstay of prevention against occupational exposure to HIV. Health care workers who sustain a significant exposure to bodily fluids that are known or likely to be contaminated should receive post exposure prophylaxis(6). Page 3 of 24 OCCUPATIONAL EXPOSURE TO HIV An occupational exposure can be defined as a percutaneous injury ( cut with a sharp instrument or needle stick) , exposure of mucosal surfaces or broken skin ( chapped skin , abraded skin , dermatitis ) or intact skin ( when contact is prolonged or involves extensive areas of skin ) with potentially infectious blood, tissues or bodily fluids (7) . These fluids include: (a) bodily fluids visibly contaminated with blood, semen, vaginal secretions and breast milk - these substances are associated with HIV transmission; (b) cerebrospinal fluid, pleural fluid, pericardial fluid, synovial fluid, perito neal fluid and amniotic fluid - these fluids carry an undetermined risk of HIV transmission; and (c) HIV containing lab specimens (unfixed organs and tissues, organ cultures and blood, concentrated virus) (7) Other bodily fluids such as urine, saliva, tears, sputum, nasal secretions, sweat, faeces and gastric content are non-infectious unless visibly blood stained (7). In the occupational setting a broad range of personnel are exposed to the risk of HIV infection. These are categorised as health care workers and non-health care workers. Health care personnel comprise of medical doctors, nurses, traditional healers, paramedics, dentists. Non-health care personnel comprise of bar bouncers, educators, sex workers and firemen(8). RISK OF OCCUPATIONAL TRANSMISSION TO HIV The first reported case of a health care worker contracting the HIV infection was documented in 1984 following a needle stick injury(9). According to 23 prospective studies conducted globally the risk of HIV infection following percutaneous injury with HIV infected blood is 0.3% and 0.09% following mucocutaneous exposure(7,10). The risk of HIV transmission following non-intact skin exposure has not been quantified but is estimated to be less than the risk for mucocutaneous exposure (11) . Whilst the risk of transmission following exposure to fluids or tissues other than HIV infected blood, which has not been quantified, is most likely lower than blood exposure (12). The risk of HIV transmission varies with the type and severity of exposure. Page 4 of 24 It is important to note that the statistics above are calculated from data acquired from developed countries. This is due to a lack of monitoring and reporting in the developing world. Occupational exposures reported from North America and Western Europe comprise 90% of cases, whilst only 4% of cases were reported from sub-Saharan Africa where approximately 70% of the worlds HIV infected population live(1). The risk of occupational transmission of HIV infection depends on multiple factors relating to the health care worker, the source patient and the circumstances of exposure(1). Genetic variation maybe responsible for reduced susceptibility to HIV infection. This can be seen in high risk groups of prostitutes and homosexual men who remain HIV free despite frequent exposure(13).This reduced susceptibility to HIV infection is associated with a deletion in the CCR5 co-receptor which inhibits viral entry into the cell thus creating a relative resistance to HIV infection(14). Cardo et al. (15) has shown the risk of HIV transmission from a percutaneous injury is enhanced under the following circumstances : (a) a deep injury; (b) injury with device that was visibly contaminated with blood; (c) injuries where needle placed directly into artery or vein; and (d) hollow bore and thick needle. These above features are consistent with a transfer of a greater quantity of blood from the source patient to the exposed health care worker. Other factors associated with increased risk of transmission following occupational exposure include : (1) prevalence of infection in the specific population : risk of occupational exposure is substantially increased due to high prevalence of HIV in developing countries; (2) frequency of activities capable of transmitting the infectious agent: unsafe practices together with cultural influence regarding injections increase the risk of occupational injuries in developing countries; (3) nature and efficacy of transmission of exposure : percutaneous injury has an increased risk of transmission compared to mucocutaneous or skin exposures; Page 5 of 24 (4) virus present in contaminated fluid and viral load : greater number of patients with primary HIV infection, advanced disease and high viral loads are present in developing countries; and (5) availability and efficacy of pre-exposure and post-exposure prophylaxis : appropriate guidelines are still not available in some developing countries(16). More than half a million health care workers (HCW’s) per year are documented to be exposed to HIV in the USA, with in excess of 50% of exposures left unreported(8). Data from Southern African countries are poor. Amongst the largest study conducted in West African countries, 45% of HCW’s sustained at least one accidental blood exposure, although over 60% of which went unreported(8). In 2001, Chris Hani Baragwanath Hospital in Gauteng revealed that 69% of its interns sustained at least one percutaneous injury. Whilst 45% of interns sustained a mucocutaneous blood exposure(18). More than 60% of exposures were unreported. A study conducted in 2002 revealed that 91% of needle stick injuries were sustained amongst junior doctors at Tygerberg Hospital. The majority of these injuries occurred “after hours “or on calls(19). Occupational exposure to HIV was further highlighted by a study conducted in Durban in 2000,in the department of Obstetrics and Gynaecology at King Edward VIII Hospital. It revealed that 13% of staff reported injuries with HIV positive patients. These injuries being percutaneous in 94% of cases. Majority of injuries occurring during emergency surgery(65%), with the highest risk group being registrars(60%)(5). Page 6 of 24 Omrani S,Freedman A. Prophylaxis of HIV infection. British Medical Bulletin. 2005;73,74:93-105 POST EXPOSURE PROPHYLAXIS AND ITS RATIONALE According to the World Health Organisation, post exposure prophylaxis refers to the medical response instituted to prevent the transmission of blood -born pathogens following a potential exposure to HIV(20). Post exposure prophylaxis refers to interventions that aim to manage specific aspects of HIV exposure and assists to prevent infection in the individual that is at risk(20). Services include first aid, counseling including assessment of risk exposure, HIV testing, and Page 7 of 24 dependent on outcome, a course of antiretroviral therapy with appropriate support and follow up(20). Post exposure prophylaxis is considered a medical emergency. Anti-retroviral drugs must be available in all health care settings and at all times for administration to employees following accidental exposure to HIV(21). PEP is based on the following factors : (16) (1) HIV infection pathogenesis, especially early in the course of infection; (2) anti-retrovirals can prevent transmission of HIV based on biological plausibility; (3) the risk benefit ratio of post exposure prophylaxis to exposed health care workers; and (4) proof of effectiveness of particular agents used for prophylaxis which may be direct or indirect HIV transmission has been shown to be significantly reduced by the post exposure administration of anti-retroviral agents as seen in several clinical studies. Although trials concerning efficacy of PEP were not randomised nor placebo controlled, data obtained concerning benefit of its use are extrapolated from animal, case control and PMTCT studies.(15,16,22). PEP CONSIDERED ON BASIS OF HIV PATHOGENESIS After the initial exposure there is a delay to systemic infection. Thus creating a “window period “during which the initiation of post exposure anti-retroviral therapy may inhibit or suppress viral entry into host cells and viral replication (16). Experimental models of HIV infection have shown that local viral replication occurs within 24 hours at the site of inoculation in tissue macrophages and dendritic cells. This stimulates host cytotoxic T cells to kill infected target cells. Failure to arrest viral replication at this stage, results in proliferation in regional lymph nodes in the following 2 - 3 days followed by systemic dissemination resulting in a viraemia in the next 3 - 5 days(23). Owing to the rapid infection of target cells following viral inoculation of the host, recommended antiretrovirals for PEP must have a rapid onset of action, a multimodal mechanism of action and high potency to be effective(23). A small study amongst HCW’s suggests evidence that host defences influence the risk of HIV infection. Following percutaneous exposure to HIV there was no Page 8 of 24 seroconversion indicating that limited viral replication can occur without infection. HIV specific T cell proliferative response was seen in majority of subjects,as this response is a major histocompatilibilty complex (MHC) class 1 specific its associated with limited viral replication within tissue macrophages(23).This indicates that host immune responses may prevent HIV infection. In a study involving 20 HCW’s with occupational HIV exposure, one group received zidovudine as PEP and the control did not. Results in the zidovudine group revealed a blunted HIV specific CTL response and that early HIV replication maybe inhibited by PEP(24). Timely initiation of anti-retrovirals post exposure to HIV may prevent or inhibit systemic infection by limiting viral replication in the target cells or regional lymph nodes(23). PEP EFFICACY IN ANIMAL STUDIES PEP has proven to be successful in animal studies in preventing the infection of primates with simian immunodeficiency virus (SIV) . Following intravenous, oral and rectal inoculation of SIV, the anti-retrovirals administered prevented infection(25,26). It is important to note that these outcomes cannot be directly extrapolated to humans. This is due to the following differences: (23) (a) infective strains ( SIV vs HIV ); (b) variance in host susceptibility to infection; (c) variance in drug metabolism; (d) inoculums route and volume; and (e) drug regimen However subsequent studies served to refine methodology and sought to provide better evidence for the efficacy of PEP(27,28). These studies revealed that delays in initiation of the first dose, decreased duration of treatment and suboptimal dosing of PEP together with larger viral inoculums on exposure is associated with decreased efficacy of ARV’s for PEP(27,28). Page 9 of 24 PEP EFFICACY IN HUMAN STUDIES The efficacy of occupational PEP in humans has not been validated in large randomised controlled trials. A retrospective study amongst HCW’s following percutaneous exposure to HIV revealed that zidovudine chemoprophylaxis reduced the risk of HIV transmission by 81% in those that took a 28 day course. However due to limitations in numbers, study design and reporting, bias could not be excluded(14). PEP has a definitive role in preventing perinatal transmission of HIV. Antepartum and intrapartum administration of zidovudine to the mother, with zidovudine administration to the neonate at 6 weeks postpartum, has proved to decrease the risk of vertical transmission by 67%(29). The therapeutic effect of zidovudine extends beyond the maternal reduction of HIV RNA in preventing vertical transmission. It also seems to offer direct protective effects to the HIV exposed but uninfected neonate born to HIV infected mothers who received no antiretroviral treatment or prophylaxis during pregnancy, labour or delivery(30). The limitations imposed by animal and human studies must be considered as well as the routes of exposure following perinatal transmission versus that of occupational transmission of HIV when evaluating the efficacy of PEP(23). PEP TREATMENT FAILURE There has been 21 cases in which PEP has failed to prevent HIV transmission in HCW’s. In the majority of cases PEP monotherapy with zidovudine was used versus dual therapy and triple drug therapy in others, in which HIV seroconversion was respectively less according to the greater number of agents utilised. Despite this evidence there has been documented cases of occupational transmission of HIV with combination drug therapy being used(31,32,33). Antiretroviral resistance testing in cases of PEP treatment failure have revealed resistant strains of the source virus to all classes of antiretrovirals as well as specific agents (23). Antiretroviral drug resistance can be suspected in source patients who despite being on prolonged therapy, display: (33) (a) clinical progression of disease; (b) falling CD4 counts; and (c) increasing viral loads (d) In addition to treatment failure due to resistant viral strains, other factors such as high viral titre, large inoculums of exposure, delayed initiation, suboptimal dosing and short duration of PEP together with decreased host immunity contribute to cases of treatment failure(23). Page 10 of 24 Morbidity and Mortality weekly report. Updated U.S Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Postexposure Prophylaxis. 2001 June/Vol.50/No.RR-11. Page 11 of 24 PEP DRUG REGIMENS Zidovudine is the only drug proven to show risk reduction in HIV transmission following occupational exposure(14). No data exists to support the addition of other ARV’s in improving the efficacy of post exposure prophylaxis. However, combination therapy of antiretrovirals in HIV infected patients aims to achieve superior suppression of viral replication compared to zidovudine monotherapy(34,35). Hence combination drug therapy enhances the efficacy of post exposure prophylaxis as a result of activity at various levels of the viral replication cycle. This is especially important with exposures associated with an increased risk of transmission. Combination therapy PEP also addresses the concern of PEP treatment failure in cases of viral resistance(33,34). However post exposure prophylaxis is poorly tolerated and associated with poor adherence in 20 - 40 % of cases due to toxicity and side effect profile(36). It is imperative that exposures are assessed according to the substance/body fluid involved and the route and severity of the exposure together with details of the source patient to guide judicious PEP therapy regimens(36). Low risk exposures require a basic PEP regimen (2 drugs) consisting of 2 nucleoside/nucleotide reverse transcriptase inhibitors(NRTI’s) viz. zidovudine(AZT) and lamivudine(3TC) or stavudine(D4T) and lamivudine(3TC). High risk exposures require an expanded regimen (3 drugs) consisting of 2 NRTI’s and a PI (lopinavir/ritonavir) or an NNRTI (efavirenz). Expanded regimens should be reserved for increased risk of transmission or in cases of suspected viral drug resistance(34,36). Latest South African guidelines regarding PEP, advocate triple drug regimen for prophylaxis and treatment of all significant exposures. Rationale for this recommendation is based on the extremely high HIV prevalence, high patient volume and attendant risk of high number of exposures. Although the risk of HIV transmission following an occupational exposure in our setting has not been quantified, the aforementioned risk factors makes these recommendations plausible(8). Page 12 of 24 PEP TIMING AND DURATION PEP is a medical emergency and requires urgent initiation of antiretrovirals within 2 hours of exposure following adequate evaluation of the HCW, exposure incident and source patient to avoid inappropriate antiretroviral therapy. If concern over source patient or complexity of exposure exists regarding instituting a basic or expanded regime, a basic regime should be immediately prescribed whilst awaiting necessary details to guide further therapy. An absolute time after which PEP has no efficacy in administration cannot be said with certainty but animal and PMTCT studies have shown that the efficacy decreases beyond 36 - 72 hours of exposure incident. Delayed PEP administration beyond 72 hours maybe advocated in circumstances of delayed presentation and increased risk of transmission (following transfusion of HIV infected blood products) under specialist advice(37,38). Duration of PEP for all regimens must be 28 days. Minimal efficacy is associated with therapy of less than 2 weeks duration and no added benefit is offered with therapy extending beyond 28 days as documented in animal and case control studies(16). Status of the Source HIV Positive Percutaneous exposure to bloodor potentially infectious Triple Therapy fluids Mucocutaneous splash or contact with open wound with Triple Therapy blood or potentially infectious fluids Percutaneous exposure, mucocutaneous splash or No PEP contact with an open wound, with non infectious bodily fluids Unknown HIV Negative Triple Therapy No PEP Triple Therapy No PEP No PEP No PEP Post Exposure Prophylaxis. The South African Journal of HIV Medicine-Winter 2008. Page 13 of 24 ADVERSE EFFECTS, TOXICITY, AND DRUG INTERACTIONS The primary objective of PEP is successful completion of 28 days of uninterrupted prophylaxis. Side effects due to prophylactic antiretroviral therapy appears to be more frequent and severe in HIV negative exposed HCW’s than in HIV positive patients on antiretroviral treatment. Side effect management is critical to completion and is often under managed. Approximately 50% of HCW’s experience adverse side effects whilst taking PEP resulting in premature discontinuation of prophylaxis in 35% of cases. Common side effects include: nausea , vomiting and diarrhoea, headaches, malaise(8,16,23). Counseling, reassurance, follow-up and prescription of anti-emetics and antidiarrhoeal agents together with modification of dosing intervals if needed serve to improve compliance without the need to change the PEP regimen(8). Zidovudine (AZT) and protease inhibitors (PI’s) are associated with significant side effects. AZT is poorly tolerated in PEP settings and shows no clear advantage over tenofovir which forms part of the preferred regimen of PEP prophylaxis in the developed world. D4T and tenofovir are associated with successful outcomes in PMTCT regimens, with D4T being far better tolerated than AZT(23,38). The use of PI’s are associated with new onset diabetes, exacerbation of preexisting diabetes, hyperglycaemia, diabetic ketoacidosis, dyslipidaemia and peripheral neuropathy. Specifically indinavir use is associated with hyperprolactinaemia and galactorrhoea whilst use in pregnancy is associated with hyperbilirubinaemia and nephrolithiasis, whilst cases of cholestatic jaundice have been reported with nelfinavir. Nelfinavir and Indinavir are generally poorly tolerated, with PI’s having several drug interactions and complicating management of several pathologies including hypertension, diabetes, asthma, tuberculosis, pregnancy, epilepsy, DVT/PE(8,16,23). Abacavir (NRTI) should be avoided due to increased risk of hypersensitivity reactions. Combination of stavudine and didanosine should be avoided due to possibility of mitochondrial toxicity and lactic acidosis (fatal and non fatal) most commonly seen in pregnancy(23). With regard to NNRTI’s, efavirenz though accepted as treatment of choice for chronic HIV infection, its use in initial PEP prophylaxis ( basic regimen) is not recommended due to the following reasons including : (23) (a) CNS side effects being common complicating the need for the first dose and impairing work ability with subsequent dosing; Page 14 of 24 (b) teratogenic to pregnant woman and should be avoided in woman of childbearing age unless effective contraception is taken and adherence is assured. Nevirapine carries a high risk of hepatotoxicity and Steven Johnsons syndrome and is associated with reverse transcriptase gene mutation, leading to cases of NNRTI resistance, when used for PEP and as result should be avoided both in PEP regimens and in pregnancy. Post Exposure Prophylaxis. The South African Journal of HIV Medicine-Winter 2008 Page 15 of 24 LEGAL FRAMEWORK OF PEP (22) Exposure to HIV and other blood borne viruses in the work place should be prevented as per the responsibility of both the employer and the employee. The Occupational Health and Safety Act No. 85 of 1993 ( OHSA ): Employers are to ensure a safe and secure work place for the employees as far as is possible. The implication of the Act regarding HIV specifically is that the employer needs to minimise the risk of infection within the workplace. Compensation for Occupational Injuries and Diseases Act No. 130 of 1993: The Act provides for compensation to be paid to an employee for illnesses or accidents sustained during the course of his or her employment. To qualify for compensation, an employee is required to prove that the HIV infection was acquired as a result of occupational exposure. It’s imperative that meticulous recording and reporting of an occupational injury is undertaken by the employee who should also be subject to HIV testing. PREVENTATIVE STRATEGIES Occupational exposures to HIV are avoidable and warrant investigation with a view to improve infection control(8). Studies have suggested that circumstances involved in predisposing the HCW to occupational exposure to HIV include (16,40) : (1) the unnecessary use of needles; (2) lack of sharps containers and needle holders; (3) repeated resheathing of needles after use; (4) lack of training of HCW’s; (5) long working hours > 40 hours/week; (6) lack of wearing gloves when tasked with needle use ; and (7) belief amongst HCW’s that HIV seroconversion following occupational exposure to HIV is low Page 16 of 24 Behaviour modification in the work place forms the cornerstone of primary preventative strategies in reducing the risk of occupational exposure to HIV. HCW’s should be: (1) educated about the risks in the workplace; (2) aware of the magnitude of these risks; (3) trained in decreasing exposure by appropriate risk reduction strategies (standard precautions ) - All patients to be treated as potential carriers of HIV - Use of appropriate personal protective equipment viz. Mask, gown, gloves, visors etc during procedures that carry a high risk of contamination with blood or bodily fluids - Meticulous handling of sharps and avoidance of injury - Proper disposal of sharps and infectious waste; (4) Training provided to modify procedures that carry an increased risk; and (5) Adequate provision of instruments and devices that reduce risk of exposure by advanced manufacturing technique Institutional policy is an important aspect of management in health care settings for post exposure management of HCW’s to potentially infectious bodily fluids. Page 17 of 24 STEP WISE APPROACH TO AN OCCUPATIONAL EXPOSURE The following are recommendations contaminated blood or bodily fluids: following exposure to potentially GENERAL MEASURES Immediate treatment of the exposure site follows washing area with soap and water. Mucous membranes that have been exposed should be irrigated with water or normal saline. Although the use of antiseptics have been encouraged by some authors, others have discouraged its use as it may impair local host defense mechanisms and has not been proven to decrease the risk of HIV transmission. Squeezing the wound has also been advised against due to the promotion of hyperaemia and inflammation at the wound site, potentially increasing systemic exposure to HIV(16,40). EVALUATION OF EXPOSURE The route and severity of exposure determines the risk of potential HIV transmission. Whilst awaiting for the source patient to be tested for HIV, PEP should be indicated in the following circumstances: (22) - breach of the skin by a sharp object that has blood, bloody fluid, or other infectious material or that has been in the source patients blood vessel - patient with blood exposed in the mouth that bites and causes bleeding in the the HCW - mucocutaneous exposure (mouth, nose, eyes ) to blood, bloody fluid or other potentially infectious material - non-intact skin exposure to blood, bloody fluid, or potentially infectious material Page 18 of 24 TESTING OF THE SOURCE PATIENT The HIV status of the source patient should be determined as soon as possible, this can be done via documented sources of the patient’s status or if unknown informed consent can be obtained prior to HIV testing. If the source patient is incapable of providing informed consent, a surrogate will be able to do so. If consent for HIV testing is refused by the source patient, the HCW should assume the patient to be HIV +ve. If the patient is HIV -ve, it is assumed there is no risk of HIV unless reasonable suspicion exists that the patient is in the “ window period “, which will necessitate continuation of PEP until lab tests ( HIV DNA PCR ) exclude the window period. REPORTING OF THE EXPOSURE The incident requires to be reported to the supervisor as soon as possible, the occupational clinic within 1-2 hours (if during working hours) and the institutional manager within 24 hours. Trained medical personnel should document the following information in the HCW’s medical record: - demographic details of the source patient chronology of the exposure type of exposure body area involved and duration of exposure HIV status of the source patient if known a descriptive report of percutaneous wounds if present circumstance of the exposure previous testing and serostatus of the exposed HCW COUNSELLING SUPPORT Supportive counselling must be available to the exposed HCW and services should include: - appropriate pre and post test counselling information on the risk of transmission of HIV information on the reduction in risk of HIV transmission with PEP information on side effects of ARV’s and methods to address it emphasis on importance of PEP adherence Page 19 of 24 The HCW should also be advised of the following: - barrier method of contraception for 6 months to avoid possible infection of sexual partners during the “ window period “ - avoid pregnancy until seroconversion has been excluded - pregnancy does not preclude the use of PEP - not to donate blood and organs for 3 months ASSESSMENT OF THE HEALTH CARE WORKER The HCW must be tested to qualify for PEP and possible compensation. Testing is based on informed consent. If the HCW refused baseline HIV testing, they do not qualify for PEP in terms of government (DOH) policy in Kwazulu-Natal and they must be informed that such refusal negates the right to any future claim for compensation in respect of that particular exposure and therefore must indemnify the Department of Health in writing. Blood must be taken confidentially from the HCW, and the details on the lab request form must document the specimen is from a HCW who sustained an occupational exposure and the contact details of the attending doctor or professional nurse must be reflected to facilitate the results being issued. HIV testing should be conducting at baseline, 6 weeks, 12 weeks and 24 weeks, whilst baseline FBC, U&E, LFT should be done to monitor for possible toxicity and should be repeated in the 2nd and 4th week. Pregnancy testing should also be done at baseline for woman of child bearing age. Page 20 of 24 CONCLUSION Developing countries are afflicted by the greatest burden of HIV/AIDS where access to antiretrovirals is limited. Health care workers are scarce but highly valued, and need to be protected from occupational hazards that pose an increased risk of acquiring HIV. Primary preventative strategies should form the mainstay of management in terms of prevention of occupational HIV exposure but in resource constrained countries this is not always possible to achieve. Post exposure prophylaxis if initiated timeously in the appropriate setting with the appropriate regimen for the appropriate duration can prevent occupational HIV infection. It is imperative to provide on-going support and counseling to the exposed HCW whose psychological burden of exposure and risk of contracting a fatal illness together with the adverse effects of antiretroviral therapy associated with PEP, may result in the loss of hospital staff resources. 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