eISSN: 1896-9151
ISSN: 1734-1922
Archives of Medical Science
Current issue Archive Manuscripts accepted About the journal Special issues Editorial board Abstracting and indexing Subscription Contact Instructions for authors
SCImago Journal & Country Rank
3/2018
vol. 14
 
Share:
Share:
more
 
 
abstract:
Clinical research

Suspected unexpected and other adverse reactions to antiretroviral drugs used as post-exposure prophylaxis of HIV infection – five-year experience from clinical practice

Justyna D. Kowalska, Ewa Pietraszkiewicz, Ewa Firląg-Burkacka, Andrzej Horban

Arch Med Sci 2018; 14, 3: 547–553
Online publish date: 2016/05/05
View full text
Get citation
ENW
EndNote
BIB
JabRef, Mendeley
RIS
Papers, Reference Manager, RefWorks, Zotero
AMA
APA
Chicago
Harvard
MLA
Vancouver
 
Introduction
With increased use of antiretroviral drugs (ARVs) in HIV uninfected persons, proper reporting on suspected unexpected serious adverse reactions (SUSARs) and continued insight into adverse drug reactions (ADRs) are needed for adequate information on safety of ARVs in such populations.

Material and methods
Medical documentation of persons receiving ARVs after non-occupational HIV exposure (non-occupational post-exposure prophylaxis – nPEP) during 5 successive years (2009–2013) was evaluated by two HIV physicians. Adverse drug reactions s and SUSARs were defined according to international standards. In statistical analyses Cox proportional hazard models were used to identify independent predictors of developing a first ADR.

Results
In total 375 persons received nPEP with the following indications: needle stick (43%), unprotected sexual intercourse (17%), rape (10%) and first aid (10%). In 84 (22%) cases the source patient was HIV positive or an active injecting drug user. In total 170 ADRs were reported. One hundred thirty-nine persons had only 1 ADR. The most frequent first ADRs were gastrointestinal disorders (22%), followed by general symptoms (9%), hypersensitivity reactions (1.6%) and CNS symptoms (1.3%). The remaining events represented less than 1% of all patients. Eight (2.1%) patients developed a SUSAR. In multivariate analyses only age at first visit to the clinic was an independent predictor of developing an ADR (HR = 1.17, 95% CI: 1.03–1.34; p = 0.02).

Conclusions
In our observations ADRs in reaction to nPEP were frequent yet usually mild events, mostly occurring in the first 2 weeks and rarely causing discontinuation. The only significant factor increasing the risk of ADR was age. SUSARs were rare, transient and clinically insignificant.

keywords:

HIV prophylaxis, post-exposure prophylaxis, adverse drug reaction, suspected unexpected serious adverse reactions

references:
Sonder GJ, van den Hoek A, Regez RM, et al. Trends in HIV postexposure prophylaxis prescription and compliance after sexual exposure in Amsterdam, 2000-2004. Sex Transm Dis 2007; 34: 288-93.
Lunding S, Katzenstein TL, Kronborg G, et al. The Danish PEP registry: experience with the use of postexposure prophylaxis (PEP) following sexual exposure to HIV from 1998 to 2006. Sex Transm Dis 2010; 37: 49-52.
McDougal SJ, Alexander J, Dhanireddy S, Harrington RD, Stekler JD. Non-occupational post-exposure prophylaxis for HIV: 10-year retrospective analysis in Seattle, Washington. PLoS One 2014; 9: e105030.
Rodriguez AE, Castel AD, Parish CL, et al. HIV medical providers’ perceptions of the use of antiretroviral therapy as nonoccupational postexposure prophylaxis in 2 major metropolitan areas. J Acquir Immune Deficien Syndrom 2013; 64 Suppl. 1: S68-79.
Service USPH. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR Recomm Rep 2001; 50 (RR-11): 1-52.
Smith DK, Grohskopf LA, Black RJ, et al. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep 2005; 54 (RR-2): 1-20.
Marrazzo JM, del Rio C, Holtgrave DR, et al. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society-USA Panel. JAMA 2014; 312: 390-409.
Fernandez-Balbuena S, Belza MJ, Castilla J, et al. Awareness and use of nonoccupational HIV post-exposure prophylaxis among people receiving rapid HIV testing in Spain. HIV Med 2013; 14: 252-7.
Kuhar DT, Henderson DK, Struble KA, et al. Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis. Infect Control Hospital Epidemiol 2013; 34: 875-92.
Diaz-Brito V, Leon A, Knobel H, et al. Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. Antivir Ther 2012; 17: 337-46.
Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010; 363: 2587-99.
Ford N, Irvine C, Shubber Z, et al. Adherence to HIV postexposure prophylaxis: a systematic review and meta-analysis. AIDS 2014; 28: 2721-7.
Kowalska JD, Firlag-Burkacka E, Niezabitowska M, et al. Post-exposure prophylaxis of HIV infection in out-patient clinic of hospital for infectious diseases in Warsaw in 2001-2002 [Polish]. Przegl Epidemiol 2006; 60: 789-94.
Kowalska JD, Firlag-Burkacka E, Niezabitowska M, Horban A. Factors influencing time from exposure to post-exposure prophylaxis of HIV infection in patients consulted in 2001-2004 in out-patient clinic of Hospital for Infectious Diseases in Warsaw [Polish]. Przegl Epidemiol 2007; 61: 357-62.
Braczkowska B, Kowalska M, Beniowski M, Zejda JE, Mazur W, Witor A. Occupational exposure to HIV in health care workers, Silesia voivodeship [Polish]. Medycyna Pracy 2010; 61: 315-22.
Krawczyk P, Bialkowska J, Dworniak D, Kamerys J, Szosland D, Jablkowski M. Is healthcare personnel the only professional group exposed to the risk of occupational HBV, HCV or HIV infections? [Polish]. Medycyna Pracy 2010; 61: 15-22.
Karris MY, Beekmann SE, Mehta SR, Anderson CM, Polgreen PM. Are we prepped for preexposure prophylaxis (PrEP)? Provider opinions on the real-world use of PrEP in the United States and Canada. Clin Infect Dis 2014; 58: 704-12.
Centers for Disease C, Prevention. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR 2011; 60: 65-8.
Prevention. CfDCa. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 Clinical Practice Guideline. Accessed on: 2 January 2015. Available from: http://www.cdc.gov/hiv/prevention/research/prep/.
McCormack S, Fidler S, Fisher M; British HIVA, British Association for Sexual H, Hiv. The British HIV Association/British Association for Sexual Health and HIV Position Statement on pre-exposure prophylaxis in the UK. Int
J STD AIDS 2012; 23: 1-4.
Minas B, Laing S, Jordan H, Mak DB. Improved awareness and appropriate use of non-occupational post-exposure prophylaxis (nPEP) for HIV prevention following a multi-modal communication strategy. BMC Public Health 2012; 12: 906.
Donnell D, Mimiaga MJ, Mayer K, Chesney M, Koblin B, Coates T. Use of non-occupational post-exposure prophylaxis does not lead to an increase in high risk sex behaviors in men who have sex with men participating in the EXPLORE trial. AIDS Behavior 2010; 14: 1182-9.
Li HC, Cheng YP, Yang CJ. Safety, tolerability and effectiveness of HIV non-occupational prophylaxis in Taiwan. J Intern AIDS Soci 2014; 17 (4 Suppl. 3): 19736.
Mayer KH, Mimiaga MJ, Cohen D, et al. Tenofovir DF plus lamivudine or emtricitabine for nonoccupational postexposure prophylaxis (NPEP) in a Boston Community Health Center. J Acquir Immune Defic Syndr 2008; 47: 494-9.
Luque A, Hulse S, Wang D, et al. Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus. Infect Control Hospital Epidemiol 2007; 28: 695-701.
Kahn JO, Martin JN, Roland ME, et al. Feasibility of postexposure prophylaxis (PEP) against human immunodeficiency virus infection after sexual or injection drug use exposure: the San Francisco PEP Study. J Infect Dis 2001; 183: 707-14.
Tosini W, Muller P, Prazuck T, et al. Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation. AIDS 2010; 24: 2375-80.
Tetteh RA, Nartey ET, Lartey M, et al. Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana. BMC Public Health 2015; 15: 573.
Choopanya K, Martin M, Suntharasamai P, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2013; 381: 2083-90.
Corneli AL, Deese J, Wang M, et al. FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis. J Acquir Immune Defic Syndr 2014; 66: 324-31.
Mandala J, Nanda K, Wang M, et al. Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial. BMC Pharmacol Toxicol 2014; 15: 77.
PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men. [2 January 2015]. Available from: http://www.proud.mrc.ac.uk/study_protocol.aspx.
Wang SA, Panlilio AL, Doi PA, White AD, Stek M Jr, Saah A. Experience of healthcare workers taking postexposure prophylaxis after occupational HIV exposures: findings of the HIV Postexposure Prophylaxis Registry. Infect Control Hospital Epidemiol 2000; 21: 780-5.
Hirsch M, Steigbigel R, Staszewski S, et al. A randomized, controlled trial of indinavir, zidovudine, and lamivudine in adults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy. J Infect Dis 1999; 180: 659-65.
Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365: 493-505.
Schleenvoigt BT, Fobiwe JP, Keller PM, Hagel S, Pletz MW. HIV post exposure prophylaxis induced bicytopenia: a case report. AIDS Res Ther 2014; 11: 11.
Puro V, Soldani F, De Carli G, et al. Drug-induced aminotransferase alterations during antiretroviral HIV post-exposure prophylaxis. AIDS 2003; 17: 1988-90.
Pietraszkiewicz E, Firlag-Burkacka E, Horban A, Kowalska JD. The suspected unexpected and serious adverse events of antiretroviral drugs used as HIV prophylaxis in HIV uninfected persons. J Intern AIDS Soc 2014; 17 (4 Suppl. 3): 19733.
FEATURED PRODUCTS
Quick links
© 2018 Termedia Sp. z o.o. All rights reserved.
Developed by Bentus.
PayU - płatności internetowe