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Zotero
EndNote
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Kvalsund MP, Haworth A, Murman DL, Velie E, Birbeck GL, 2009. Closing gaps in antiretroviral therapy access: human immunodeficiency virus-associated dementia screening instruments for non-physician healthcare workers. Am J Trop Med Hyg 80: 1054–1059.
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Patient-Reported Adverse Effects Associated with Combination Antiretroviral Therapy and Coadministered Enzyme-Inducing Antiepileptic Drugs
Melissa A. Elafros
Melissa A. Elafros
Department of Internal Medicine, Johns Hopkins Bayview Medical Center, Baltimore, Maryland.
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Gretchen L. Birbeck
Gretchen L. Birbeck
Department of Neurology, University of Rochester, Rochester, New York.
Epilepsy Care Team, Chikankata Hospital, Mazabuka, Zambia.
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Epilepsy Care Team, Chikankata Hospital, Mazabuka, Zambia.
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Joseph C. Gardiner
Joseph C. Gardiner
Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, Michigan.
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Omar K. Siddiqi
Omar K. Siddiqi
Global Neurology Program, Division of Neuroimmunology, Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Department of Internal Medicine, University of Zambia School of Medicine, Lusaka, Zambia.
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Department of Internal Medicine, University of Zambia School of Medicine, Lusaka, Zambia.
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Izukanji Sikazwe
Izukanji Sikazwe
Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.
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Nigel Paneth
Nigel Paneth
Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, Michigan.
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Christopher M. Bositis
Christopher M. Bositis
Greater Lawrence Family Health Center, Lawrence, Massachusetts.
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Jason F. Okulicz
Jason F. Okulicz
Infectious Disease Service, San Antonio Military Medical Center, San Antonio, Texas.
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Concurrent treatment with combination antiretroviral therapy (cART) and an enzyme-inducing antiepileptic drug (EI-AED) is common in resource-limited settings; however, the incidence and impact of adverse effects in cotreated patients is largely unknown. Symptoms of adverse effects were assessed by both spontaneous report and checklist for 145 human immunodeficiency virus (HIV)–infected Zambian adults initiating various treatment combinations, such as cART with an EI-AED (N = 20), cART only (N = 43), or neither drug (untreated; N = 82). At study baseline, the cART + EI-AED group reported more headache, generalized fatigue, problems with concentration, and depression than the untreated group (P < 0.01 for all). At 2 weeks, a greater proportion of cART + EI-AED participants reported increased nausea or vomiting compared with baseline (P < 0.05). Adverse effects did not appear to impact self-reported adherence at 2 weeks as 100% cART adherence was reported in 19 of 20 (95%) and 42 of 43 (98%) cART + EI-AED and cART-only participants, respectively; 100% EI-AED adherence was reported in 19 of 20 (95%) participants. However, adherence at 6 months was suboptimal in both groups with 18 of 33 (56%) participants on cART experiencing greater than 1-week lapse in pharmacy-reported medication supply. Our results highlight the need to educate patients about the increased potential for nausea and vomiting with cART + EI-AED cotreatment. Although adherence was high early during treatment, adherence should be reinforced overtime to minimize the potential for HIV and/or epilepsy treatment failure.
Author Notes
Financial support: The project described was supported by the Fogarty International Center and the National Institute of Neurological Disorders and Stroke (NINDS) under award 1R21NS073509. Melissa A. Elafros was supported in part by an MD/PhD Fellowship from Spectrum Health, the AMA Foundation, and the Lois C. Walker Endowed Fund for Student Research at the College of Human Medicine, Michigan State University. Omar K. Siddiqi was supported by an American Academy of Neurology Clinical Research Fellowship. Gretchen L. Birbeck, Omar K. Siddiqi, and Izukanji Sikazwe received a grant (1R21NS073509) from the National Institutes of Health (NIH) Fogarty International Center and the National Institute of Neurological Disorders and Stroke (NINDS) for this work. Omar K. Siddiqi received a Clinical Research Training Fellowship for work related to this manuscript.
Authors' addresses: Melissa A. Elafros, Johns Hopkins Bayview Medical Center, Baltimore, MD, E-mail: melafro1@jhmi.edu. Gretchen L. Birbeck, Strong Epilepsy Center, Department of Neurology, University of Rochester, Rochester, NY, E-mail: gretchen_birbeck@urmc.rochester.edu. Joseph C. Gardiner and Nigel Paneth, Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI, E-mails: jgardiner@epi.msu.edu and paneth@epi.msu.edu. Omar K. Siddiqi, Beth Israel Deaconess Medical Center, Boston, MA, E-mail: osiddiqi@bidmc.harvard.edu. Izukanji Sikazwe, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia, E-mail: izukanji.sikazwe@cidrz.org. Christopher M. Bositis, Greater Lawrence Family Health Center, Lawrence, MA, E-mail: cbositis@glfhc.org. Jason F. Okulicz, Infectious Disease Service, Brooke Army Medical Center, Fort Sam Houston, TX, E-mail: jason.okulicz@amedd.army.mil.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Max B, Sherer R, 2000. Management of the adverse effects of antiretroviral therapy and medication adherence. Clin Infect Dis 30 (Suppl 2): S96–S116.
-
2.
Monforte A, Lepri A, Rezza G, Pezzotti P, Antinori A, Philips A, Angarano G, Colangeli V, de Luca A, Ippolito G, Caggese L, Soscia F, Feilice G, Gritti F, Narciso P, Tirelli U, Moroni M, 2000. Insights into the reason for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naive patients. Aids Alert 14: 499–507.
-
3.
Wasti SP, Simkhada P, Randall J, Freeman JV, van Teijlingen E, 2012. Factors influencing adherence to antiretroviral treatment in Nepal: a mixed-methods study. PLoS One 7: e35547.
-
4.
World Health Organization, 2013. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. A Public Health Approach. Geneva, Switzerland: World Health Organization.
-
5.
Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW; AIDS Clinical Trials Unit Outcomes Committee, 2001. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol 54 (Suppl 1): S77–S90.
-
6.
Ammassari A, Murri R, Pezzotti P, Trotta MP, Ravasio L, De Longis P, Lo Caputo S, Narciso P, Pauluzzi S, Carosi G, Nappa S, Piano P, Izzo CM, Lichtner M, Rezza G, d'Arminio Monforte A, Ippolito G, Moroni M, Wu AW, Antinori A, 2001. Self-reported symptoms and medication side effects influence adherence to highly active antiretroviral therapy in persons with HIV infection. J Acquir Immune Defic Syndr 28: 445–449.
-
7.
World Health Organization, 2013. HIV/AIDS Programme: Surveillance of Antiretroviral Drug Toxicity within Antiretroviral Treatment Programmes. Technical Brief: Surveillance of Antiretroviral Toxicity. Geneva, Switzerland: World Health Organization.
-
8.
Tapsfield J, Mathews T, Lungu M, Van Oosterhout JJ, 2011. Underreporting of side effects of standard first-line ART in the routine setting in Blantyre, Malawi. Malawi Med J 23: 115–117.
-
9.
Johnson MO, Stallworth T, Neilands TB, 2003. The drugs or the disease? Causal attributions of symptoms held by HIV-positive adults on HAART. AIDS Behav 7: 109–117.
-
10.
Nachega JB, Hsu AJ, Uthman OA, Spinewine A, Pham PA, 2012. Antiretroviral therapy adherence and drug-drug interactions in the aging HIV population. AIDS 26 (Suppl 1): S39–S53.
-
11.
Romanelli F, Ryan M, 2002. Seizures in HIV-seropositive individuals: epidemiology and treatment. CNS Drugs 16: 91–98.
-
12.
Ji P, Damle B, Xie J, Unger SE, Grasela DM, Kaul S, 2008. Pharmacokinetic interaction between efavirenz and carbamazepine after multiple-dose administration in healthy subjects. J Clin Pharmacol 48: 948–956.
-
13.
Birbeck GL, French JA, Perucca E, Simpson DM, Fraimow H, George JM, Okulicz JF, Clifford DB, Hachad H, Levy RH; Quality Standards Subcommittee of the American Academy of Neurology; Ad Hoc Task Force of the Commission on Therapeutic Strategies of the International League Against Epilepsy, 2012. Evidence-based guideline: antiepileptic drug selection for people with HIV/AIDS: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Ad Hoc Task Force of the Commission on Therapeutic Strategies of the International League Against Epilepsy. Neurology 78: 139–145.
-
14.
Okulicz JF, Grandits GA, French JA, George JM, Simpson DM, Birbeck GL, Ganesan A, Weintrob AC, Crum-Cianflone N, Lalani T, Landrum ML; The Infectious Disease Clinical Research Program HIV Working Group, 2011. Virologic outcomes of HAART with concurrent use of cytochrome P450 enzyme-inducing antiepileptics: a retrospective case control study. AIDS Res Ther 8: 18.
-
15.
Okulicz JF, Grandits GA, French JA, Perucca E, George JM, Landrum ML, Acosta EP, Birbeck GL, 2013. The impact of enzyme-inducing antiepileptic drugs on antiretroviral drug levels: a case-control study. Epilepsy Res 103: 245–253.
-
16.
Birbeck G, Chomba E, Ddumba E, Kauye F, Mielke J, 2007. Lack of appropriate treatment for people with comorbid HIV/AIDS and epilepsy in sub-Saharan Africa. Epilepsia 48: 1424–1425.
-
17.
Wright E, Brew BJ, Lal L, Ali ST, Arayawichanont A, Imran D, Kamarulzaman A, Kongsaengdao S, Kruy L, Merati TP, Samintharapanya K, Sarim C, Tau G, Thangsing C, Vin-Samnang C, Wesselingh SL, 2008. Response to Birbeck et al. Epilepsia 49: 541–543.
-
18.
Carpay JA, Aldenkamp AP, van Donselaar CA, 2005. Complaints associated with the use of antiepileptic drugs: results from a community-based study. Seizure 14: 198–206.
-
19.
Perucca P, Gilliam FG, 2012. Adverse effects of antiepileptic drugs. Lancet Neurol 11: 792–802.
-
20.
Elafros MA, Bui E, Birbeck GL, 2014. Medication side effects among people with epilepsy taking phenobarbital in Zambia. Epilepsy Res 108: 1680–1684.
-
21.
Kellinghaus C, Engbring C, Kovac S, Moddel G, Boesebeck F, Fischera M, Anneken K, Klonne K, Reichelt D, Evers S, Husstedt IW, 2008. Frequency of seizures and epilepsy in neurological HIV-infected patients. Seizure 17: 27–33.
-
22.
Wong MC, Suite ND, Labar DR, 1990. Seizures in human immunodeficiency virus infection. Arch Neurol 47: 640–642.
-
23.
Kaufman KR, 2011. Antiepileptic drugs in the treatment of psychiatric disorders. Epilepsy Behav 21: 1–11.
-
24.
Kvalsund MP, Haworth A, Murman DL, Velie E, Birbeck GL, 2009. Closing gaps in antiretroviral therapy access: human immunodeficiency virus-associated dementia screening instruments for non-physician healthcare workers. Am J Trop Med Hyg 80: 1054–1059.
-
25.
Ministry of Health, Zambia, 2007. National Guidelines: Management of HIV Infected People. Lusaka, Zambia: Ministry of Health.
-
26.
Wu AW, Rubin HR, Mathews WC, Ware JE Jr, Brysk LT, Hardy WD, Bozzette SA, Spector SA, Richman DD, 1991. A health status questionnaire using 30 items from the Medical Outcomes Study. Preliminary validation in persons with early HIV infection. Med Care 29: 786–798.
-
27.
Fellay J, Boubaker K, Ledergerber B, Bernasconi E, Furrer H, Battegay M, Hirschel B, Vernazza P, Francioli P, Greub G, Flepp M, Telenti A; Swiss HIV Cohort Study, 2001. Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. Lancet 358: 1322–1327.
-
28.
Cleary PD, Fowler FJ Jr, Weissman J, Massagli MP, Wilson I, Seage GR 3rd, Gatsonis C, Epstein A, 1993. Health-related quality of life in persons with acquired immune deficiency syndrome. Med Care 31: 569–580.
-
29.
Whalen CC, Antani M, Carey J, Landefeld CS, 1994. An index of symptoms for infection with human immunodeficiency virus: reliability and validity. J Clin Epidemiol 47: 537–546.
-
30.
Ware JE Jr, Sherbourne CD, 1992. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30: 473–483.
-
31.
Holzemer WL, Hudson A, Kirksey KM, Hamilton MJ, Bakken S, 2001. The revised Sign and Symptom Check-List for HIV (SSC-HIVrev). J Assoc Nurses AIDS Care 12: 60–70.
-
32.
Baker G, Jacoby A, Francis P, Chadwick D, 1994. Initial development, reliability, and validity of a patient-based adverse drug event scale. Epilepsia 35: 20.
-
33.
Salinsky MC, Storzbach D, 2005. The Portland Neurotoxicity Scale: validation of a brief self-report measure of antiepileptic-drug-related neurotoxicity. Assessment 12: 107–117.
-
34.
Aldenkamp AP, Baker G, Pieters MS, Schoemaker HC, Cohen AF, Schwabe S, 1995. The Neurotoxicity Scale: the validity of a patient-based scale, assessing neurotoxicity. Epilepsy Res 20: 229–239.
-
35.
Uijl SG, Uiterwaal CS, Aldenkamp AP, Carpay JA, Doelman JC, Keizer K, Vecht CJ, de Krom MC, van Donselaar CA, 2006. A cross-sectional study of subjective complaints in patients with epilepsy who seem to be well-controlled with anti-epileptic drugs. Seizure 15: 242–248.
-
36.
Birbeck G, Kvalsund M, Byers P, Bradbury R, Mang'ombe C, Organek N, Kaile T, Sinyama A, Sinyangwe S, Malama K, Malama C, 2011. Neuropsychiatric and socioeconomic status impact antiretroviral adherence and mortality in rural Zambia. Am J Trop Med Hyg 85: 782–789.
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