Nephrotoxicity Associated with Concomitant Use of Ledipasvir-Sofosbuvir and Tenofovir in a Patient with Hepatitis C Virus and Human Immunodeficiency Virus Coinfection

Pharmacotherapy

Volumn 36, Issue 9, 2016, Pages e148-e153

  Bunnell, Kristen L ^a   Vibhakar, Sonia ^b   Glowacki, Robert C ^a,c   Gallagher, Maureen A ^b   Osei, Albert M ^c   Huhn, Gregory ^b,c  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b Cook Country Health and Hospitals System ^*  (United States)

^c Jr Hospital of Cook County   (United States)

Author keywords

adverse drug reaction; antiretrovirals; hepatitis C; nephrotoxicity

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; BICARBONATE; CREATININE; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; LACTIC ACID; LEDIPASVIR PLUS SOFOSBUVIR; PREDNISONE; TENOFOVIR DISOPROXIL;

ACIDOSIS; ACUTE KIDNEY FAILURE; ACUTE KIDNEY TUBULE NECROSIS; ADULT; ADVERSE OUTCOME; ANION GAP; ARTICLE; CASE REPORT; CD4 LYMPHOCYTE COUNT; CLINICAL PRACTICE; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DISEASE ASSOCIATION; DIZZINESS; DRUG DOSE REDUCTION; DRUG POTENTIATION; DRUG SAFETY; DRUG WITHDRAWAL; ECHOGRAPHY; EMERGENCY WARD; FEMALE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 1A; HOSPITAL PATIENT; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMAN TISSUE; HYPOKALEMIA; INTERSTITIAL NEPHRITIS; KIDNEY BIOPSY; LACTATE BLOOD LEVEL; LIVER STIFFNESS; MICROSCOPY; MIDDLE AGED; MIXED INFECTION; NEPHROTOXICITY; PH MEASUREMENT; PHYSICAL EXAMINATION; PROTEINURIA; PYURIA; RELATIVE DENSITY; TRANSIENT ELASTOGRAPHY; TREATMENT DURATION; URINALYSIS; VIRUS LOAD;

EID: 84990227022     PISSN: 02770008     EISSN: 18759114     Source Type: Journal    
DOI: 10.1002/phar.1803     Document Type: Article

References (34)

1. Florian J, Mishra P, Arya V, et al. Direct-acting antiviral drugs for the treatment of chronic hepatitis C virus infection: interferon free is now. Clin Pharmacol Ther 2015;98:394–402.
2. AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology 2015;62:932–54.
3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents: considerations for antiretroviral use in patients with coinfections. Washington, DC: Department of Health and Human Services; 2015.
4. Naggie S, Cooper C, Saag M, et al. Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med 2015;373:705–13.
5. Gilead Sciences, Inc. Harvoni (ledipasvir and sofosbuvir) package insert. Foster City, CA; 2015.
6. Jafari A, Khalili H, Dashti-Khavidaki S. Tenofovir-induced nephrotoxicity: incidence, mechanism, risk factors, prognosis and proposed agents for prevention. Eur J Clin Pharmacol 2014;70:1029–40.
7. Winston J, Chonchol M, Gallant J, et al. Discontinuation of tenofovir disoproxil fumarate for presumed renal adverse events in treatment-naïve HIV-1 patients: meta-analysis of randomized clinical studies. HIV Clin Trials 2014;15:231–45.
8. Ryom L, Mocroft A, Kirk O, et al. Association between antiretroviral exposure and renal impairment among HIV-positive persons with normal baseline renal function: the D:A: D study. J Infect Dis 2013;207:1359–69.
9. Rodriguez-Nóvoa S, Alvarez E, Labarga P, Soriano V. Renal toxicity associated with tenofovir use. Expert Opin Drug Saf 2010;9:545–59.
10. Brennan A, Evans D, Maskew M, et al. Relationship between renal dysfunction, nephrotoxicity and death among HIV adults on tenofovir. AIDS 2011;25:1603–9.
11. Waheed S, Attia D, Estrella MM, et al. Proximal tubular dysfunction and kidney injury associated with tenofovir in HIV patients: a case series. Clin Kidney J 2015;8:420–5.
12. Rodríguez-Nóvoa S, Labarga P, D'avolio A, et al. Impairment in kidney tubular function in patients receiving tenofovir is associated with higher tenofovir plasma concentrations. AIDS 2010;24:1064–6.
13. Herlitz LC, Mohan S, Stokes MB, Radhakrishnan J, D'Agati VD, Markowitz GS. Tenofovir nephrotoxicity: acute tubular necrosis with distinctive clinical, pathological, and mitochondrial abnormalities. Kidney Int 2010;78:1171–7.
14. Schaaf B, Aries SP, Kramme E, Steinhoff J, Dalhoff K. Acute renal failure associated with tenofovir treatment in a patient with acquired immunodeficiency syndrome. Clin Infect Dis 2003;37:e41–3.
15. Zimmermann AE, Pizzoferrato T, Bedford J, Morris A, Hoffman R, Braden G. Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions. Clin Infect Dis 2006;42:283–90.
16. Hamzah L, Booth JW, Jose S, et al. Renal tubular disease in the era of combination antiretroviral therapy. AIDS 2015;29:1831–6.
17. Sise ME, Hirsch JS, Canetta PA, Herlitz L, Mohan S. Nonalbumin proteinuria predominates in biopsy-proven tenofovir nephrotoxicity. AIDS 2015;29:941–6.
18. Hernandez J, Tarbox L, Anstead G, Dyer C. Tenofovir related acute interstitial nephritis: a case series. (Abstract 147). Am J Kidney Dis 2014;63:A1–121.
19. Poizot-Martin I, Solas C, Allemand J, et al. Renal impairment in patients receiving a tenofovir-cART regimen: impact of tenofovir trough concentration. J Acquir Immune Defic Syndr 2013;62:375–80.
20. German P, Pang P, West S, Han L, Sajwani K, Mathias A. Drug interactions between direct-acting anti-HCV antivirals sofosbuvir and ledipasvir and HIV antiretrovirals. 15th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; 2014; Washington, DC.
21. Gilead Sciences, Inc. Viread (tenofovir disoproxil fumarate) package insert. Foster City, CA; 2015.
22. Osinusi A, Townsend K, Kohli A, et al. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. JAMA 2015;313:1232–9.
23. Mechain M, Peix C, Duvignaud A, Minot A, Sazio C, Pedebosq D. Drug-drug interaction between ledipasvir/sofosbuvir and tenofovir + boosted PI: case report on major renal implications. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2015; San Diego, CA: American Society for Microbiology.
24. Wanchoo R, Thakkar J, Schwartz D, Jhaveri KD. Harvoni (ledipasvir with sofosbuvir)-induced renal injury. Am J Gastroenterol 2016;111:148–9.
25. Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Ann Pharmacother 2007;41:674–80.
26. Parkhie SM, Fine DM, Lucas GM, Atta MG. Characteristics of patients with HIV and biopsy-proven acute interstitial nephritis. Clin J Am Soc Nephrol 2010;5:798–804.
27. Perazella MA, Markowitz GS. Drug-induced acute interstitial nephritis. Nat Rev Nephrol 2010;6:461–70.
28. Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet 2015;385:2606–15.
29. Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis 2016;16:43–52.
30. Bam RA, Yant SR, Cihlar T. Tenofovir alafenamide is not a substrate for renal organic anion transporters (OATs) and does not exhibit OAT-dependent cytotoxicity. Antivir Ther 2014;19:687–92.
31. Markowitz M, Zolopa A, Squires K, et al. Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults. J Antimicrob Chemother 2014;69:1362–9.
32. Doyle E, Custodio J, Pang PS, et al. Lack of drug interactions between boosted and unboosted tenofovir alafenamide-based antiretroviral single tablet regimens (emtricitabine/rilpivirine/tenofovir alafenamide and elvitegravir/cobicistat/emtricitamine/tenofovir alafenamide) and the anti-HCV single tablet regimen ledipasvir/sofosbuvir (abstract 727). Open Forum Infect Dis 2015;2(Suppl 1):S29.
33. Dick TB, Lindberg LS, Ramirez DD, Charlton MR. A clinician's guide to drug-drug interactions with direct-acting antiviral agents for the treatment of hepatitis C viral infection. Hepatology 2016;63:634–43.
34. Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med 2015;373:714–25.