HIV Postexposure Prophylaxis (PEP) in a Nigerian Tertiary Health Institution

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1 HIV Postexposure Prophylaxis (PEP) in a Nigerian Tertiary Health Institution Journal of the International Association of Physicians in AIDS Care 10(3) ª The Author(s) 2011 Reprints and permission: sagepub.com/journalspermissions.nav DOI: / Cajetan C. Onyedum, MBBS, FWACP, FCCP 1, Chinwe Chukwuka, MBBS, FMCP, FCCP 1, Chukwuemeka A. Iyoke, MBBS, MPH, FWACS 2, and Olusegun Funsho Omotola, BPharm 3 Abstract Background: Use of PEP drugs is useful in preventing seroconversion following accidental occupational or nonoccupational exposures, thereby limiting further spread of HIV. Objective: This study aims to evaluate the clinicodemographic characteristics of patients accessing PEP services in a tertiary health institution. Study Design: This was a retrospective review of patients who obtained postexposure prophylaxis from the HIV clinic of a University Teaching Hospital in Nigeria. Results: A total of 116 clients sought for PEP services during the study period. The commonest setting of exposure was needle injury (44.8%). Half of the clients presented within 24 hours following exposure. Being a male and knowing HIV status of source patient independently increased the likelihood of early presentation following exposure (P <.05). None of the patients that obtained the PEP drugs came for follow-up visits. Conclusion/Recommendation: Late presentation for PEP services following exposure means that more awareness needs to be created to facilitate early presentation. Keywords postexposure, prophylaxis, HIV, Nigeria Introduction Human immunodeficiency virus (HIV) postexposure prophylaxis (PEP) involves taking a brief course (usually 28 days) of antiretroviral drugs (ARVs) as soon as possible 1 after exposure to HIV to reduce and if possible eliminate the possibility of acquiring HIV infection. Exposure to HIV can occur in an occupational or nonoccupational setting. Use of ARVs following exposure to HIV is a form of secondary HIV prevention that has been shown to reduce the incidence of HIV infections. 2 PEP aims to inhibit the replication of the initial inoculums of the virus thereby preventing the establishment of chronic HIV infection. 2 The 2007 Nigeria national guidelines for HIV and AIDS treatment and care recommended PEP following exposure of an individual to potentially infectious body fluids in occupational setting and nonoccupational settings like rape. 3 PEP is generally not recommended for people who seek care more than 72 hours after exposure or those who are at no substantial risk for HIV transmission. PEP is not an alternative to the adoption and observation of universal precautions against exposures to potentially infective fluids and materials. The use of PEP following exposure is justified by the initial findings suggesting that the odds of HIV infection among health care workers after HIV exposure via needle stick injuries were reduced by about 81% following the use of PEP in retrospective case-controlled studies. 2 Limited data however exist about the effectiveness of PEP following sexual and other nonoccupational exposures. 4,5 Health care workers including young doctors and phlebotomists who often come in contact with blood products are at more risk of being exposed to HIV via needle prick injuries and splashes of potentially infective body fluids. Following exposure to potentially infective fluids, there is often heightened anxiety among the victims which warrant a lot of counseling. Even with the provision of the PEP services, challenges often arise with regard to how many drugs to be used (either 2 or 3) and which drug combinations should be used. Nevirapine-based combinations are generally avoided because of increased incidence of adverse drug reactions when used in people with high level of CD4 lymphocytes, which is 1 Department of Medicine, UNTH, Enugu, Nigeria 2 Department of Obstetrics and Gynaecology, UNTH, Enugu, Nigeria 3 Department of Pharmacy, UNTH, Enugu, Nigeria Corresponding Author: Onyedum Cajetan C., Department of Medicine, UNTH, Enugu , Nigeria cajetan.onyedum@unn.edu.ng

2 172 Journal of the International Association of Physicians in AIDS Care 10(3) often the case in patients seeking PEP services. Other challenges in HIV PEP provision are related to adherence to therapy and completion of the regimen duration. A review of available literature shows that there is paucity of data concerning the provision and delivery of HIV PEP services in sub-saharan Africa despite the high prevalence of HIV and invariably the high number of exposures in different occupational and nonoccupational settings. Little is also known about the factors responsible for late presentation for PEP by victims of accidental occupational exposure to body fluids in this area. This study aims to review the provision of the PEP services in a tertiary health institution in Nigeria with a view to: finding out the number of people that accessed the services during the study period, identifying the sociodemographic characteristics and profile of people accessing the services, establishing the average time it took to access the services from exposure time, identifying the number of people who completed the whole stages of the therapy including coming back for post PEP HIV counseling and testing, and determining sociodemographic and clinical characteristics that are associated with late presentation. Methods Study Setting This study was conducted at the University of Nigeria Teaching Hospital, Ituku Ozalla Enugu, a tertiary hospital in South East Nigeria. The hospital has about 700 beds, with a workforce of more than 5000 health care workers of different categories. The hospital receives patients from Enugu and other parts of the South East region of Nigeria comprising 5 states. HIV PEP services were initially incorporated into the antiretroviral (ARV) drug program from inception of the HIV treatment clinic in 2002 but data regarding clients who accessed care initially were generally lacking until 3 years ago when a comprehensive multidisciplinary PEP unit was established in the hospital to address the problem of increasing exposures of health care workers to HIV in the work place. Provision of ARV drugs started at this centre in February 2002 under the subsidized Federal Ministry of Health s ARV programme. From May 2008, provision of HIV services at the hospital is now supported by the Presidential Emergency Plan for AIDS Relief (PEPFAR) programme run by the Harvard School of Public health in collaboration with AIDS Prevention Initiative in Nigeria (APIN). Health care workers and individuals who are accidentally exposed to potentially infective fluids and sources are expected to present to the PEP service points including ART clinic, outpatient and inpatient pharmacy, medical counseling units for pre-pep assessment following occupational and nonoccupational exposures. These service points are manned by PEP focal persons and victims are managed using our standard operating procedure. PEP assessment starts with opening of folder and registration followed by counseling and collection of blood for baseline HIV screening before commencement of PEP drugs for those who meet the national guidelines for provision of HIV PEP drugs. ARV drugs including PEP drugs are provided for free of charge at this centre. Study Design This was a retrospective review of patients who obtained PEP from the ART clinic of UNTH over a two-and-half-year period Data Collection Data were retrieved retrospectively from the records of all patients who sought HIV PEP services at the University Teaching Hospital from January 2007 to June Data on demographic characteristics, type of exposure, time to presentation, baseline HIV status of exposed and source patient, whether PEP was offered, and post-pep HIV status were retrieved and recorded in a data collection sheet. Data Analysis Data were subsequently entered and analyzed using SPSS version 15.0 for windows (SPSS Inc. Chicago, Illinois). Descriptive statistics of demographic and clinical variables were presented as frequencies, percentage, means, standard deviation, and range. Bivariate analysis was done to determine the association of sociodemographic and clinical characteristics of patients with time of presentation following exposure. Tests of significance were done with Pearson chi-square (or Fisher Exact test where appropriate). Binary logistic regression models were constructed to determine which sociodemographic or clinical characteristics constituted independent risk factors for late presentation for PEP and results reported as adjusted odds ratios. P values.05 were considered significant. Ethical Approval Ethical approval was obtained from the University of Nigeria Teaching Hospitals Ethics committee. Results A total of 116 exposed victims presented at the various service points for PEP services within the study period. There were 74 females (64%) and 42 males (36%). The mean age of the victims was years. A total of 84% were aged 21 to 40 years. In all, 105 HIV-exposed individuals including 11 victims who declined baseline HIV screening were eventually offered the PEP drugs. Medical practitioners especially young house officers accounted for most occupational exposures (Table 1).

3 Onyedum et al 173 Table 1. Showing the Frequency Distribution of Demographic and Clinical Characteristics of Clients Who Received PEP Characteristics Frequency Percentage Yearly distribution of clients (Up till June 2009) Male Female Age category (years) Civil servant Health worker House officer Laboratory scientist Med/nursing student Medical doctor Nurse/midwife Seamstress HIV status of victim Positive Negative Unknown 15 (refused to do tests) 13.0 Needle prick Rape Splash of body fluid Human bite Blade cut IV Status of source Positive Negative Unknown Time before seeking PEP Within 24 hours hours After 72 hours The highest setting of HIV exposure was needle prick injuries accounting for 44.8% followed by rape (25.9%). There were 4 cases due to human bite (Table 1). Fifty eight (50%) exposed victims presented within 24 hours of exposure (Table 1) Seven of the victims (6.9% of those screened) tested positive to HIV screening test while 15 of the exposed victims refused to have a baseline HIV screening test. HIV status of source patients was known only in 37 exposures (31.9%). Twenty of them were positive, and 17 were negative to HIV antibodies. None of the patients who obtained the PEP drugs came for follow-up visit including coming for post-pep-hiv screening. There were no recorded cases of adverse drug reactions following the PEP drugs during the study period. Table 2 shows the results of bivariate analysis to determine sociodemographic and clinical characteristics associated with time of presentation for PEP. Gender, occupation, and HIV status of source were significantly associated with the time of presentation for PEP following exposure (P.05 for all variables). Table 3 shows the results of binary logistic regression to determine which sociodemographic and clinical characteristics predicted late presentation for PEP. Only gender and HIV status of exposure were significant. Being a male predicted increased likelihood of presenting early for PEP compared to being a female. Similarly, knowing the HIV status of source increased the likelihood of presenting early for PEP compared to not knowing the HIV status of source. Discussion This study showed that clients with occupational and nonoccupational exposures sought for HIV PEP services at this tertiary health institution during the study period. Commonest setting of HIV exposures during the study period was due to needle prick injuries as has been previously documented. 6 It is worrisome that a large proportion of people who presented had exposures following rape which is a nonoccupational exposure. High rates of nonoccupational exposures following sexual assault have been reported previously. 6-9 A good proportion of exposed patients up to 50% presented after 24 hours despite the fact that they had the exposure within the hospital environment. This probably shows poor awareness of the availability and the need for early seeking of PEP among the health care workers in this facility. This is unlike in a previous study in Nigeria where all the exposed health care workers were seen within 24 hours of exposure. 10 It is important to note that this previous study evaluated only health care workers unlike the present study that looked at both occupational and nonoccupational exposures treated at the hospital. Late presentations for PEP following HIV exposure especially beyond 72 hours is likely to lead to lack of benefits from PEP regimen and such clients are generally not offered PEP drugs as stipulated in the national guidelines. Most of the exposed victims that presented after 72 hours of exposure were due to sexual abuse following rape. This is not surprising because nonoccupational exposures like rape are often associated with stigma and legal proceedings thereby delaying the time for presentation at hospitals for accessing PEP care. Comprehensive and holistic management of rape cases should include offering of PEP services early enough to the affected victims to ensure maximum benefits. Factors such as known HIV status of source and male sex independently predicted increased likelihood of early presentation following exposure. This suggests that males tend to present earlier than females and that those who know the HIV status of source also tend to present earlier. These reasons for the gender difference are not clear. However, they may be related to the fact that males tend to take independent decisions whereas females tend to seek the opinion of male

4 174 Journal of the International Association of Physicians in AIDS Care 10(3) Table 2. Showing the Results of Bivariate Analysis to Determine Factors Associated with Time of Presentation for PEP Following Exposure Characteristic Time of Presentation Chi-square or Within 24 Hours After 24 Hours Fisher Exact Test P Value Male w 2 ¼ a Female Age category (yrs) FET ¼ Civil servant 4 3 FET¼ a Health worker 5 0 House officer 14 4 Laboratory scientist 3 3 Med/nursing student Medical doctor Nurse/midwife 7 11 Seamstress 1 0 Needle prick FET ¼ Rape Splash of body fluid Human bite 1 3 Blade cut 3 0 HIV Status of source Positive 15 5 X 2 ¼ a Negative 15 2 Unknown Abbreviations: FET, Fisher exact test; w 2 ¼ chi-square. a Significant. partners before taking decisions concerning their own health. Knowing the HIV status of source may leave one with less need for delay arising from time taken to determine the appropriate step to take. It thus appears that more females than males sought for the services (63.8%) if both occupational and nonoccupational exposures are considered, but when the cases due to rape are excluded, the proportion of males to females tend toward the same (42; 44). More females seeking PEP services following HIV exposures have been reported previously even in occupational setting only. 10 However, a study from Jos, Nigeria, reported that more males were exposed. 6 However, the number of exposed victims studied in these earlier studies was smaller than those evaluated in this present study. The overall 6.9% prevalence of HIV infection among the screened victims was comparable to the local prevalence of HIV in Enugu state (5.8%) and was, however, higher than the national prevalence (4.6%) of HIV in Nigeria. 11 The apparent disparity in the prevalence rates could be due to the methodology of ascertaining the national prevalence rates which is a Table 3. Showing the Results of Binary Logistic Regression to Determine Factors that Predict Late Presentation for PEP Characteristic Adjusted Odds Ratio P Value Male a Female Age category (years) Civil servant 8E þ Health worker House officer 2E þ Laboratory scientist 1E þ Medical/nursing student 7E þ Medical doctor 1E þ Nurse/midwife 1E þ Seamstress HIV Status of source Positive a Negative a Unknown Needle prick 4E þ Rape 2E þ Splash of body fluid 4E þ Human bite 3E þ Blade cut a Significant. sentinel study looking at women who came to register at antenatal clinics. Doctors, especially young preregistration house officers, were more exposed especially in the setting of needle prick injuries. This is possibly a reflection of the naivety of the younger doctors in handling sharp objects and on the increased frequency of contact with potentially infective fluids and situations. They are also more likely to use syringes and needles to draw blood or give intravenous injections than other health workers. The HIV status of source was known in 31.9% of cases. This is however lower than 100% and 80.7% got in previous studies. 10,12 The apparent low frequency of known HIV status of source in this cohort may be due to high number of rape cases which makes it difficult to trace the source. If possible, it is important that the HIV status of source is known as this could be of help in choosing the regimen for the affected victim, and also for proper counseling and follow-up of the source if the status is not already known to the source. About 11 out of the 15 patients who refused to be screened still received the PEP drugs. Further review showed that these were highly placed doctors who used their positions in the hospital to access the drugs despite the fact that they did not meet the national guidelines which stipulates that the exposed

5 Onyedum et al 175 victims must be screened and found to be negative to HIV. 3 This kind of practice must be discouraged as patients who are HIV positive at the time of exposure should not be offered PEP drugs as this is often done with 2 drug combinations and for a short duration thus encouraging the development of resistance strains. It is rather surprising that none of clients came for follow-up visits despite the fact that they were supposed to be counseled. This is unlike in a previous study in Nigeria where only about 16.7% failed to complete their follow-up clinic visit. It becomes difficult to evaluate the effectiveness of the services provided since a major outcome measure, which is seroconversion, cannot be determined from this study. Equally, information on the completion of therapy and side effect profile of the regimen is not available due to lack of follow-up visits. The stigma erroneously attached to HIV is a possible reason why these visits are missed. It is possible that these clients were not properly counseled on the need for follow-up visits. Clients still do not want to be associated with the clinic and will keep visits to the barest minimum. We realize that most of the clients were given the complete 28-day PEP pack at commencement of the therapy. This may need to be changed as it is possible that if the packs are broken down to weekly supplies, the exposed victims are more likely to turn up for follow up during weekly drug collections. This however needs to be weighed against the background of some clients that may not keep these appointments and thus will not complete the PEP regimen. The major limitation of this study is that it is retrospective, and documentation of activities offered to the clients was poor most especially regarding the kind of drug regimen started for each patient and in the case of health workers, there was no detailed record of the hospital department where they were deployed. The exact duration in hours before seeking PEP was not documented too. In conclusion, HIV exposure at this health institution has involved mostly young health workers, and most clients were females. Needles stick injuries and rape constituted the commonest settings of exposure. Late presentation for PEP is quite high and is associated with being a female or not knowing the HIV status of source. We recommend the following measures. More awareness needs to be created to enable exposed victims present early enough for the services. Counseling sessions should be made more robust to enable clients know why they should have baseline HIV screening before accessing PEP drugs and why they should come for follow-up visits. Strict adherence to the national guidelines should be maintained in all situations. There should be better documentation of services rendered to clients. It is our opinion that the assessment forms used for baseline data capture should be modified to collect information that will enable clients be traced if they fail to turn up for follow-up visits. We suggest that a trial run for weekly PEP drugs be undertaken to determine if this will improve clients follow-up visits as they come for their drugs. Declaration of Conflicting Interests The author(s) declared no conflicts of interest with respect to the authorship and/or publication of this article. Funding The author(s) received no financial support for the research and/or authorship of this article. References 1. Jost J. Post-exposure HIV prevention within and outside the hospital. Ther Umsch. 1998;55(5): Young TN, Arens FJ, Kennedy GE, Laurie JW, Rutherford G. Antiretroviral post-exposure prophylaxis (PEP) for occupational HIV exposure. Cochrane Database Syst Rev. 2007;(1): CD National guidelines for HIV and AIDS Treatment and Care in adolescents and adults. Nigeria: Federal Ministry of Health Abuja; Bryant J, Baxter L, Hird S. Non-occupational post exposure prophylaxis for HIV: a systematic review. Health Techno Assess. 2009;13(14):iii, ix-x, Fong C. Post-exposure prophylaxis for HIV infection after sexual assault: when is it indicated? Emerg Med J. 2001;18(4): Ojoh R, Simpet W, Agaba P, Agbaji O, Idoko J. Profile of post exposure prophylaxis in APIN PLUS Jos Nigeria. 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 22-25, 2007; Sydney, Australia. 7. Siika AM, Nyandiko WM, Mwangi A, et al. The structure and outcomes of a HIV postexposure prophylaxis program in a high HIV prevalence setup in western Kenya. J Acquir Immune Defic Syndr. 2009;51(1): Kim JC, Askew I, Muvhango L, et al. Comprehensive care and HIV prophylaxis after sexual assault in rural South Africa: the Refentse intervention study. BMJ. 2009;338:b515. doi: / bmj.b Olowookere SA, Fatiregun AA. 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