Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia

Demissie Assegu Fenta; Agete Tadewos Hirigo

doi:doi:10.11648/j.ajhr.20140206.23

| Peer-Reviewed

Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia

Demissie Assegu Fenta, Agete Tadewos Hirigo

Published in American Journal of Health Research (Volume 2, Issue 6)

Received: 29 November 2014 Accepted: 11 December 2014 Published: 18 December 2014

Views: Downloads:

Download PDF

Share This Article

Twitter
Linked In
Facebook

Abstract

Background: During stavudine phase-out in a resource limited countries, Zidovudine or Tenofovir is used to substitute stavudine. However, data concerning any difference in liver enzymes level after therapy change (switching) in Ethiopia is very limited. Methods: This prospective cohort study was carried out from May 2013 to July 2014 at ART clinic of Hawassa University teaching hospital. Of hundred fifty HIV-infected; immunologically stable adults receiving triple antiretroviral therapy: 120 were patients receiving stavudine based regimen with either of efavirenz or nevirapine during ART initiation (switch group); and the rest 30 patients were receiving zidovudine based regimen with either of efavirenz or nevirapine and also never switched (control group). Lamivudine is common for both groups. Levels of serum liver enzymes were determined and hepatotoxicity assessed according to World Health Organization ART guideline. Statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 20. Results: Serum mean AST and ALT level in the switch group decreased significantly over the time observed (p=<0.0001 for both enzymes); however ALP level was significantly increased (p=<0.0001). Hepatotoxicity in the switch group was significantly decreased (AST grade > 1 from 35.8% to15.8%; and ALT from 20.8% to 3.3%) after 12 month of therapy change. Conclusion: Significantly a decreased hepatotoxicity was observed at the 12 month of post switch and this indicated that a substitution of stavudine to Zidovudine could have a potential to reverse hepatotoxicity. However, significantly decreased white blood cells count and abnormally increased level of ALP enzyme should require periodic monitoring and further investigations.

Published in	American Journal of Health Research (Volume 2, Issue 6)
DOI	10.11648/j.ajhr.20140206.23
Page(s)	397-403
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Hepatotoxicity, HAART Switching, HIV/AIDS, Hawassa, Ethiopia

References

[1]	F.J. Palella, K.M. Delaney, A.C. Moorman, M.O. Loveless, J. Palella FJ, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998; 338(13): 853–60.
[2]	Kalyesubula R, Kagimu M, Opio KC, Kiguba R, Semitala CF, Schlech WF et al. Hepatotoxicity from first line antiretroviral therapy: an experience from a resource limited setting. Afr Health Sc 2011; 11(1): 16 –23.
[3]	WHO. Anti-retroviral therapy for HIV infection in adults and adolescents 2006. http://www.who.int/hiv/pub/arv/adult2010/en/index.html. accessed on 02 Oct 2014
[4]	Mankhatithan W, Lueangniyomkul A, Manosuthin W. Hepatotoxicity in patients co-infected coinfected with tuberculosis and HIV-1 while receiving non-nucleoside reverse transcriptase inhibitors based antiretroviral therapy and rifampicin containing antituberculosis drugs. Southeast Asian J Trop Med Public Health 2011; 42(3): 651-58.
[5]	Sulkowski MS. Drug-induced liver injury associated with antiretroviral therapy that includes HIV-1 protease inhibitors. Clin Infect Dis 2004; 38(2):90-7.
[6]	Rivero A, Mira JA, Pineda JA. Liver toxicity induced by non-nucleoside reverse transcriptase inhibitors. J Antimicrobial Chemotherapy 2007; 59(3): 342-6.
[7]	Brück S, Witte S, Brust J, Schuster D, Mosthaf F, Procaccianti M et al. Hepatotoxicity in patients prescribed Efavirenz or Nevirapine. Euro J Med Res 2008; 13(7): 343-48.
[8]	WHO. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach.. http://www.who.int/about/licensing/copyright_form/en/index.html. accessed on 02 Oct 2014.
[9]	Gallant JE, Hoffmann CJ. Johns Hopkins HIV guideline of Hepatotoxicity. http://www.hopkinsguides.com/hopkins/ub/view/Johns_Hopkins_HIV_Guide/545091/all/Hepatotoxicity. accessed on 05 Oct 2014
[10]	Leth F, Phanuphak P, Stroes E, Gazzard B, Cahn P, Raffi FRP et al. Nevirapine and efavirenz elicit different changes in lipid profiles in antiretroviral therapy-naïve patients infected with HIV-1. PLoS Med 2004; 1(1): e19.
[11]	WHO. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach. World Health organization, 2010. http:// whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf. accessed on 03 Oct 2014
[12]	Claas GJ, Jülg B, Röling J, Goebel FD, Bogner JR. Metabolic and anthropometric changes one year after switching from didanosine/stavudine to tenofovir in HIV-infected patients. Eur J Med Res 2007; 12: 54-6.
[13]	Pollard R, Robinson P, Dransfield K. Safety profile of nevirapine, a non-nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus infection. Clin Ther 1998; 20(6):1071–92.
[14]	Martinez E, Blanco J, Arnaiz J. Hepatotoxicity in HIV-1–infected patients receiving nevirapine-containing antiretroviral therapy. AIDS 2001; 15(10): 1261-8.
[15]	Stern J, Robinson P, Love J, Lanes S, Imperiale M, Mayers D. A comprehensive hepatic safety analysis of nevirapine in different populations of HIV infected patients. J Acquir Immune Defic Syndr 2003;. 34 (Suppl 1): 21–33.
[16]	Wit F, Weverling G, Jurriaans S, Lange J. Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. J Infect Dis 2002; 186: 23–31.
[17]	Ogedegbe AO, Sulkowski MS. Antiretroviral-associated liver injury. Clin Liver Dis 2003; 7(2): 475-99.
[18]	Severe P, Leger P, Charles M, Noel F, Bonhomee G, Bios G et al. Antiretroviral therapy in a thousand patients with AIDS in Haiti. N Eng J Med 2005; 353(22):2325-34.
[19]	Kumarasamy N, Lai A, Cecelia AJ, Saghayam S, Solomon S, Flanigan T et al. Toxicities and adverse events following generic HAART in south Indian HIV-infected individuals: In proceedings of the 7th International Congress on Drug Therapy and HIV Infection. Glasgow, United Kingdom, 2004.
[20]	Anekthananon T, Ratanasuwan W, Techasathit W, Sonjai A, Suwanagool S. Safety and efficacy of a simplified fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) for the treatment of advanced HIV-infected patients: a 24-week study. J Med Assoc Thai 2004; 87(7): 760-7.
[21]	Pujari SN, Patel AK, Naik E, Patel KK, Dravid A, Patel JK et al. Effectiveness of generic fixed-dose combinations of highly active antiretroviral therapy for treatment of HIV infection in India. J Acquir Immune Defic Syndr 2004; 37(5):1566-9.
[22]	Oosterhout JJ, Bodasing N, Kumwenda JJ, Nyirenda C, Mallewa J, Cleary PR et al. Evaluation of antiretroviral therapy results in a resource-poor setting in Blantyre, Malawi. Trop Med Int Health 2005; 10(5): 464-70.
[23]	Cantrell R, Chi B, Mulenga L, Sinkala M, Levy J, Stringer E et al. Incidence and predictors of hepatotoxicity among patients receiving nevirapine (NVP)-containing antiretroviral therapy (ART) in Zambia: in Program and abstracts of the 16th International AIDS Conference (Toronto, Canada). Toronto, Canada: International AIDS Society, 2006.
[24]	Reisler R, Liou S, Servoss J, Robbins G, Theodore D, Murphy R et al. Incidence of hepatotoxicity and mortality in 21 adult antiretroviral treatment trials: ACTG Liver Diseases Focus Group. 1st International AIDS Society Conference on HIV Pathogenesis and Treatment, 2001.
[25]	Manfredi R, Calza L, Chiodo F. Efavirenz versus Nevirapine in current clinical practice: A prospective, open-label observational study. JAIDS, 2004; 35(5):492-502.
[26]	Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B et al. Comparison of first-line antiretroviral therapy with regimens including Nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomized open-label trial, the 2NN study. Lancet 2004; 363(9417):1253-63.
[27]	Sanne I, Mommeja-Marin H, Hinkle J, Bartlett JA, Lederman MM, Maartens G et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis 2005; 191 (6): 825-829.
[28]	Leith L, PilieroP, Storfer S, Mayers D, Hinzmann R. Appropriate use of nevirapine for long- term therapy. J Infect Dis 2005; 192(3):545-6, 2005.

Cite This Article

Plain Text BibTeX RIS

APA Style

Demissie Assegu Fenta, Agete Tadewos Hirigo. (2014). Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia. American Journal of Health Research, 2(6), 397-403. https://doi.org/10.11648/j.ajhr.20140206.23

Copy | Download

ACS Style

Demissie Assegu Fenta; Agete Tadewos Hirigo. Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia. Am. J. Health Res. 2014, 2(6), 397-403. doi: 10.11648/j.ajhr.20140206.23

Copy | Download

AMA Style

Demissie Assegu Fenta, Agete Tadewos Hirigo. Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia. Am J Health Res. 2014;2(6):397-403. doi: 10.11648/j.ajhr.20140206.23

Copy | Download

@article{10.11648/j.ajhr.20140206.23,
  author = {Demissie Assegu Fenta and Agete Tadewos Hirigo},
  title = {Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia},
  journal = {American Journal of Health Research},
  volume = {2},
  number = {6},
  pages = {397-403},
  doi = {10.11648/j.ajhr.20140206.23},
  url = {https://doi.org/10.11648/j.ajhr.20140206.23},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajhr.20140206.23},
  abstract = {Background: During stavudine phase-out in a resource limited countries, Zidovudine or Tenofovir is used to substitute stavudine. However, data concerning any difference in liver enzymes level after therapy change (switching) in Ethiopia is very limited.  Methods: This prospective cohort study was carried out from May 2013 to July 2014 at ART clinic of Hawassa University teaching hospital. Of hundred fifty HIV-infected; immunologically stable adults receiving triple antiretroviral therapy: 120 were patients receiving stavudine based regimen with either of efavirenz or nevirapine during ART initiation (switch group); and the rest 30 patients were receiving zidovudine based regimen with either of efavirenz or nevirapine and  also never switched (control group). Lamivudine is common for both groups. Levels of serum liver enzymes were determined and hepatotoxicity assessed according to World Health Organization ART guideline. Statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 20. Results: Serum mean AST and ALT level in the switch group decreased significantly over the time observed (p= 1 from 35.8% to15.8%; and ALT from 20.8% to 3.3%) after 12 month of therapy change. Conclusion: Significantly a decreased hepatotoxicity was observed at the 12 month of post switch and this indicated that a substitution of stavudine to Zidovudine could have a potential to reverse hepatotoxicity. However, significantly decreased white blood cells count and abnormally increased level of ALP enzyme should require periodic monitoring and further investigations.},
 year = {2014}
}

Copy | Download

TY  - JOUR
T1  - Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia
AU  - Demissie Assegu Fenta
AU  - Agete Tadewos Hirigo
Y1  - 2014/12/18
PY  - 2014
N1  - https://doi.org/10.11648/j.ajhr.20140206.23
DO  - 10.11648/j.ajhr.20140206.23
T2  - American Journal of Health Research
JF  - American Journal of Health Research
JO  - American Journal of Health Research
SP  - 397
EP  - 403
PB  - Science Publishing Group
SN  - 2330-8796
UR  - https://doi.org/10.11648/j.ajhr.20140206.23
AB  - Background: During stavudine phase-out in a resource limited countries, Zidovudine or Tenofovir is used to substitute stavudine. However, data concerning any difference in liver enzymes level after therapy change (switching) in Ethiopia is very limited.  Methods: This prospective cohort study was carried out from May 2013 to July 2014 at ART clinic of Hawassa University teaching hospital. Of hundred fifty HIV-infected; immunologically stable adults receiving triple antiretroviral therapy: 120 were patients receiving stavudine based regimen with either of efavirenz or nevirapine during ART initiation (switch group); and the rest 30 patients were receiving zidovudine based regimen with either of efavirenz or nevirapine and  also never switched (control group). Lamivudine is common for both groups. Levels of serum liver enzymes were determined and hepatotoxicity assessed according to World Health Organization ART guideline. Statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 20. Results: Serum mean AST and ALT level in the switch group decreased significantly over the time observed (p= 1 from 35.8% to15.8%; and ALT from 20.8% to 3.3%) after 12 month of therapy change. Conclusion: Significantly a decreased hepatotoxicity was observed at the 12 month of post switch and this indicated that a substitution of stavudine to Zidovudine could have a potential to reverse hepatotoxicity. However, significantly decreased white blood cells count and abnormally increased level of ALP enzyme should require periodic monitoring and further investigations.
VL  - 2
IS  - 6
ER  -

Copy | Download

Author Information

Demissie Assegu Fenta

Hawassa University College of Medicine and Health Science Teaching Hospital, Hawassa, Southern Ethiopia
Agete Tadewos Hirigo

Hawassa University College of Medicine and Health Science Teaching Hospital, Hawassa, Southern Ethiopia

Download PDF

Sections

Plain Text BibTeX RIS

APA Style

Demissie Assegu Fenta, Agete Tadewos Hirigo. (2014). Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia. American Journal of Health Research, 2(6), 397-403. https://doi.org/10.11648/j.ajhr.20140206.23

Copy | Download

ACS Style

Demissie Assegu Fenta; Agete Tadewos Hirigo. Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia. Am. J. Health Res. 2014, 2(6), 397-403. doi: 10.11648/j.ajhr.20140206.23

Copy | Download

AMA Style

Demissie Assegu Fenta, Agete Tadewos Hirigo. Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia. Am J Health Res. 2014;2(6):397-403. doi: 10.11648/j.ajhr.20140206.23

Copy | Download

@article{10.11648/j.ajhr.20140206.23,
  author = {Demissie Assegu Fenta and Agete Tadewos Hirigo},
  title = {Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia},
  journal = {American Journal of Health Research},
  volume = {2},
  number = {6},
  pages = {397-403},
  doi = {10.11648/j.ajhr.20140206.23},
  url = {https://doi.org/10.11648/j.ajhr.20140206.23},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajhr.20140206.23},
  abstract = {Background: During stavudine phase-out in a resource limited countries, Zidovudine or Tenofovir is used to substitute stavudine. However, data concerning any difference in liver enzymes level after therapy change (switching) in Ethiopia is very limited.  Methods: This prospective cohort study was carried out from May 2013 to July 2014 at ART clinic of Hawassa University teaching hospital. Of hundred fifty HIV-infected; immunologically stable adults receiving triple antiretroviral therapy: 120 were patients receiving stavudine based regimen with either of efavirenz or nevirapine during ART initiation (switch group); and the rest 30 patients were receiving zidovudine based regimen with either of efavirenz or nevirapine and  also never switched (control group). Lamivudine is common for both groups. Levels of serum liver enzymes were determined and hepatotoxicity assessed according to World Health Organization ART guideline. Statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 20. Results: Serum mean AST and ALT level in the switch group decreased significantly over the time observed (p= 1 from 35.8% to15.8%; and ALT from 20.8% to 3.3%) after 12 month of therapy change. Conclusion: Significantly a decreased hepatotoxicity was observed at the 12 month of post switch and this indicated that a substitution of stavudine to Zidovudine could have a potential to reverse hepatotoxicity. However, significantly decreased white blood cells count and abnormally increased level of ALP enzyme should require periodic monitoring and further investigations.},
 year = {2014}
}

Copy | Download

TY  - JOUR
T1  - Changes in Serum Liver Enzymes Level after Switching from Stavudine/Lamivudine to Zidovudine/Lamivudine in NNRTIs Based Anti-Retroviral Regimens in Hawassa, Southern Ethiopia
AU  - Demissie Assegu Fenta
AU  - Agete Tadewos Hirigo
Y1  - 2014/12/18
PY  - 2014
N1  - https://doi.org/10.11648/j.ajhr.20140206.23
DO  - 10.11648/j.ajhr.20140206.23
T2  - American Journal of Health Research
JF  - American Journal of Health Research
JO  - American Journal of Health Research
SP  - 397
EP  - 403
PB  - Science Publishing Group
SN  - 2330-8796
UR  - https://doi.org/10.11648/j.ajhr.20140206.23
AB  - Background: During stavudine phase-out in a resource limited countries, Zidovudine or Tenofovir is used to substitute stavudine. However, data concerning any difference in liver enzymes level after therapy change (switching) in Ethiopia is very limited.  Methods: This prospective cohort study was carried out from May 2013 to July 2014 at ART clinic of Hawassa University teaching hospital. Of hundred fifty HIV-infected; immunologically stable adults receiving triple antiretroviral therapy: 120 were patients receiving stavudine based regimen with either of efavirenz or nevirapine during ART initiation (switch group); and the rest 30 patients were receiving zidovudine based regimen with either of efavirenz or nevirapine and  also never switched (control group). Lamivudine is common for both groups. Levels of serum liver enzymes were determined and hepatotoxicity assessed according to World Health Organization ART guideline. Statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 20. Results: Serum mean AST and ALT level in the switch group decreased significantly over the time observed (p= 1 from 35.8% to15.8%; and ALT from 20.8% to 3.3%) after 12 month of therapy change. Conclusion: Significantly a decreased hepatotoxicity was observed at the 12 month of post switch and this indicated that a substitution of stavudine to Zidovudine could have a potential to reverse hepatotoxicity. However, significantly decreased white blood cells count and abnormally increased level of ALP enzyme should require periodic monitoring and further investigations.
VL  - 2
IS  - 6
ER  -

Copy | Download