Clinical Outcomes and Renal Safety in HIV/AIDS Patients on Tenofovir-containing Regimens in Lesotho
Journal of Family Medicine and Health Care
Volume 5, Issue 4, December 2019, Pages: 38-44
Received: Aug. 13, 2019;
Accepted: Sep. 2, 2019;
Published: Oct. 9, 2019
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Molungoa Sello, Department of Pharmacy, National University of Lesotho, Roma, Lesotho; Medicine Usage in South Africa, North-West University, Potchefstroom, South Africa
Dorcas Rakumakoe, Medicine Usage in South Africa, North-West University, Potchefstroom, South Africa
Martie Lubbe, Medicine Usage in South Africa, North-West University, Potchefstroom, South Africa
Maseabata Ramathebane, Department of Pharmacy, National University of Lesotho, Roma, Lesotho; Medicine Usage in South Africa, North-West University, Potchefstroom, South Africa
Marike Cockeran, Medicine Usage in South Africa, North-West University, Potchefstroom, South Africa
Although TDF use has been associated with acceptable safety, reports of rare manifestation of renal disease in HAART regimens that include TDF have been documented. The study was conducted at Paballong HIV/AIDS care centre in Berea, Lesotho. The aim of the study was to evaluate clinical outcomes and renal safety in HIV/AIDS patients taking TDF-containing HAART regimens. Descriptive, observational, longitudinal retrospective design was followed on 255 adults on TDF-containing HAART regimens at the study area; from October 2015 to March 2016. Data captured on a data collection tool included baseline, follow-up and end-line characteristics of clinical outcomes and renal safety. Patients gained an estimated body weight of to 0.10 kg from baseline (p < 0.05) at any age. Females were on average 2.49 kg heavier than males (p < 0.05). The CD4 cell count results estimated a daily increase of 0.20 cells/mm3 at any age. The mean CD4 cell count of female patients was 69.13 cells/mm3 higher than for males (p = 0.02). The eGFR results contended that sex, age and body weight are risk factors to developing renal insufficiency. The eGFR declined by 0.78 ml/min/1.73m2 over the treatment duration at any age of treatment initiation (p < 0.05), while the average eGFR for females was lower (13.05 ml/min) (p < 0.05). Clinical outcomes manifesting by weight gain and CD4 cell count elevation improve at any age and better in females. The renal function is progressively deteriorated at any age and worsened in females.
Clinical Outcomes and Renal Safety in HIV/AIDS Patients on Tenofovir-containing Regimens in Lesotho, Journal of Family Medicine and Health Care.
Vol. 5, No. 4,
2019, pp. 38-44.
Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA, 2004; 292 (2): 191-201.
Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med, 2006; 324 (3): 251-260.
Chua AC, Llorin RM, Lai K, et al. Renal safety of tenofovir containing antiretroviral regimen in a Singapore cohort. AIDS Res. Ther, 2012; 9: 1-5.
Cooper RD, Wiebe N, Smith N, et al. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-Infected patients. Clin. Infect. Dis., 2010; 51: 496-505.
Crum-Cianflone N, Ganesan A, Teneza-Mora N, et al. Prevalence and factors associated with renal dysfunction among HIV-infected patients. AIDS patient care st, 2010; 24 (6): 353-360.
Johnson DC, Chasela C, Maliwichi M, et al. Tenofovir use and renal insufficiency among pregnant and general adult population of HIV-infected, ART-naive individuals in Lilongwe, Malawi. PloS one, 2012; 7 (7): 1-7.
Kalyesubula R & Perazella MA. Nephrotoxicity of HAART. Hindawi: 2011; 1-11.
Sadre A, Munshi N, Dhande S, et al. Tenofovir-induced acute kidney injury in HIV-infected patients in western India: a resource limited setting perspective. JIAS, 2012; 15: 1.
United Nations Programme on HIV/AIDS. Access to antiretroviral therapy in Africa: status report on progress towards the 2015 targets. 2013. http://www.unaids.org/sites/default/files/media_asset/20131219_AccessARTAfricaStatusReportProgresstowards2015Targets_en_0.pdf Date of access: 13 Nov. 2016.
World Health Organization. Treat all people living with HIV, offer antiretrovirals as additional prevention choice for people at "substantial" risk. 2016b; http://www.who.int/mediacentre/news/releases/2015/hiv-treat-all-recommendation/en Date of access: 15 Mar. 2016.
World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2016c; http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf?ua=1 Date of access: 13 Nov. 2016.
United States of America. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 2016; http://aidsinfo.nih.gov/guidelines Date of access: 15 Sep. 2016.
Kalayjian RC, Lau B, Mechekano RN, et al. Risk factors for chronic kidney disease in a large cohort of HIV-1 infected individuals initiating antiretroviral therapy in routine care. J Acquir Immune Defic Syndr, 2012; 26 (15): 1907-1915.
Avihingsanon A, Gatechompol S, Sapsirisavat V, et al. Efficacy and safety of a once-daily single-tablet regimen of tenofovir, lamivudine, and efavirenz assessed at 144 weeks among antiretroviral-naïve and experienced HIV-1-infected Thai adults. Int J Infect Dis, 2017; 61: 89-96.
Louie M, Hogan C, Hurley A, et al. Determining the antiviral activity of tenofovir disoproxil fumarate in treatment-naive chronically HIV-1-infected individuals. J Acquir Immune Defic Syndr, 2003; 17 (8): 1151-1156.
Pozniak AL, Gallant JE, DeJesus E, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes-a 96-week analysis. J Acquir Immune Defic Syndr, 2006; 43 (5): 535-540.
Arribas JR, Pozniak AL, Gallant JE, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients 144-week analysis. J Acquir Immune Defic Syndr, 2008; 47 (1): 74-78.
Min IS, Lee CH, Shin IS, et al. Treatment outcome and renal safety of 3-year Tenofovir Disoproxil Fumarate therapy in chronic hepatitis B patients with preserved glomerular filtration rate. Gut liver, 2019 13 (1): 93-103.
Woodward CLN, Hall AM, Williams IG, et al. Tenofovir-associated renal and bone toxicity. HIV med, 2009; 10: 482-487.
Hagos Y & Wolf NA. Assessment of the role of renal organic anion transporters in drug-induced nephrotoxicity. Toxins, 2010; 2: 2055-2082.
Kohler JJ, Hosseini SH, Hoying-Brandt A, et al. Tenofovir renal toxicity targets mitochondria of renal proximal tubules. Lab invest, 2009; 89 (5): 513-519.
Post FA, Yazdanpanah Y, Schembri G, et al. Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomized, double-blind, active-controlled phase 3 trial. HIV Clin Trials, 2017; 18 (3): 135-140.
Kohler JJ, Hosseini SH, Green E, et al. Tenofovir renal proximal tubular toxicity is regulated by OAT1 and MRP4 transporters. Lab invest, 2011. 91 (6): 852-858.
Lerma EV & Nissenson A. Nephrology secrets. 3rd ed. Philadelphia, PA: Mosby. 2012.
Fernandez-Fernandez B, Montoya-Ferrer A, Sanz AB, et al. Tenofovir nephrotoxicity: 2011 update. AIDS Res Treat, 2011: 1-11.
Lesotho. Ministry of Health and Social Welfare. National guidelines for HIV & AIDS Care and treatment. Maseru. 2010.
Mwase T, Kariisa E, Doherty J, et al. Lesotho health systems assessment 2010. Maseru: Health Systems 2020. 2010.
United States Software Announcement. International Business Machines Statistical Package for the Social Sciences (IBM® SPSS®) version 22® Statistical software. 2013.
Razali NM & Wah YB. Power comparisons of Shapiro-Wilk, Kolmogorov-Smirnov, Lilliefors and Anderson-Darling tests. JOSMA, 2011; 2 (1): 21-33.
Denue BA, Ikunaiye PNY & Denue CBA. Body mass index changes during highly active antiretroviral therapy in Nigeria. East Mediterr Health J, 2013; 19: 89-97.
Olawumi HO, Olatunji PO, Salami AK, et al. Effect of highly active antiretroviral therapy on CD4 count and weight in AIDS patients seen at the Uith, Ilorin. Niger J Clin Pract, 2008; 11 (4): 312-315.
Squires K. The impact of sex/gender on antiretroviral therapy and its complications. Women and HIV, 2003; 43.
Lakey W, Yang L, Yancy W, et al. Short communication from wasting to obesity: initial antiretroviral therapy and weight gain in HIV-infected persons. AIDS res hum retroviruses, 2013; 29 (3): 435-440.
Maskew M, Brennan AT, Westreich D, et al. Gender differences in mortality and CD4 count response among virally suppressed HIV-positive patients. J Womens Health, 2013; 22 (2): 113-120.
Chow WZ, Lim SH, Ong LY, et al. Impact of HIV-1 subtype on the time toCD4+ T-cell recovery in combination antiretroviral therapy (cART)-experienced patients. PloS one, 2015; 10 (9): 1-9.
Castilho JL, Melekhin VV & Sterling TR, et al. Sex differences in HIV outcomes in the highly active antiretroviral therapy era: a systematic review. AIDS res hum retroviruses, 2014; 30 (5): 446-456.
Poggio, ED, Rule AD, Tanchanco R, et al. Demographic and clinical characteristics associated with glomerular filtration rates in living kidney donors. Kidney Int, 2009; 75 (10): 1079-1087.
Stohr W, Walker AS, Munder P, et al. Estimating glomerular filtration rate in HIV-infected adults in Africa: comparison of Cockroft-Gault and modification of diet in renal disease formulae. Antivir. Ther, 2008; 13: 761-770.
Pujari, S. N., Smith, C., Makane, A., Youle, M., Johnson, M., Bele, V., Joshi, K., Dabhade, D. & Bhagani, S. 2014. Higher risk of renal impairment associated with tenofovir use amongst people living with HIV in India: a comparative cohort analysis between Western India and United Kingdom. BMC Infect Dis, 12 (173): 1-7.
Lesotho. Ministry of Health. National guidelines on the use of antiretroviral therapy for HIV prevention and treatment. 5th ed. Maseru. 2016.