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Table 2 Characteristics of included studies

From: Tenofovir-associated kidney disease in Africans: a systematic review

Author: year

Setting/Region*

Age group of interest

Design

Sample size (on TDF containing regimen)

Treatment regimen

Comparator

Duration on ART at baseline

Duration of follow up

Outcome measurements

Mulenga: 2014

Zambia: SA

≥16 years

RC

62,230 (38,716)

TDF-based regimen

Non TDF containing

–

12 months

eGFR by CKD-EPI

De Waal: 2017

South Africa: SA

≥ 16 years

RC

15,156 (15,156)

TDF containing

–

Median 12.9 months 

–

eGFR using MDRD, CKD-EPI and CG. No factor for black race used

Ndagije: 2015

Uganda; EA

Adults

Implementation: (TSR)

10,225 (53)

TDF based

–

> 2 years

2 years

SCr, urinalysis, clinical signs and symptoms

Reid: 2008

DART: Uganda and Zimbabwe

≥16 years

OC within RCT

3316 (2469)

TDF/3TC/AZT

Non TDF

Naïve at baseline

96 weeks

Creatinine levels and eGFR by CG

Stöhr: 2011

South Africa: SA

Adults

OC within RCT

3316 (2469)

TDF/3TC/AZT

Non TDF

Naïve at baseline

96 weeks 

eGFR by CG

Shamu: 2015

Zimbabwe: SA

Adults ≥ 18yrs

RC

1986 (1862)

TDF containing

Non TDF

 

6411 person yrs

Two consecutive CrCl < 60 ml/min by the CG equation, or two consecutive urine dipsticks positive for protein (≥ 30 g/L albumin)

Myer, 2013

South Africa: SA

Women ≥ 25 years

RC

1861 (238)

TDF, 3TC/FTC, and EFV

Men and non-pregnant women, similar regimen

initiating Rx

2 years

CrCl and absolute serum creatinine values

Dekert: 2017

Zambia; SA

≥16 years

RC

1118 (1118)

TDF containing

–

≥ 90 days

Median 1461 days

eGFR, CKD-Epi formula

Mayanja: 2017

Uganda; EA

Adults

PC

1095 (608)

TDF containing

236 on a PI + other

≥6 months, Median 9.4 years

 

sUrea, sCr, Fractional Tubular phosphates reabsorption & eGFR. (CG/MDRD/CKD-Epi)

Kamkuemah: 2015

South Africa: SA

Adults

Cohort

1092 (1092)

TenolamE

–

initiating ART

12 months

CrCl after 12 months on ART measured by glomerular filtration rate (eGFR) using CG

Salome: 2016

Uganda; EA

Adults

CS

953 (568)

TDF containing

385 non TDF

≥ 6 months. Median 9.3 years

Cross sectional

eGFR by CKI-Epi

Bygrave: 2011

Lesotho: SA

Adults

RC

933 (566)

TDF containing

–

pts initiating TDF ART 

12 months

CrCl using CG

Brennan: 2011

South Africa: SA

Adults

RC

890 (890)

TDF-containing

–

pts initiating TDF ART

48 months

Nephrotoxicity defined as decline in kidney function from baseline secondary to a toxin. CrCl to estimate eGFR using CG

Mwafongo: 2014

Eastern and Southern Africa:

Women ≥ 13 years

RCT

741 (741)

TDF containing

–

TDF naïve at baseline

48 weeks median 2.3 years

CrCl or clinical renal diagnosis

Zachor : 2016

South Africa: SA

Adults

RC

650 (650)

TDF containing

–

ART naïve

median 47 w

eGFR by CKD-EPI and confirmed by MDRD

Mugomeri: 2014

Lesotho: SA

Adults

RC

485 (312)

TDF containing

173 on other

> 6 months

> 6 months

eGFR by CG

Zannou: 2015

Benin; WA

Adults ≥ 16yrs

CS

480 (62)

 

2 NRTIs + 1 NNRTI. Those on 2nd line comprised 2 nucleosides RTIs + 1 PI

> 3 nths

Cross sectional

CrCl by CG

Wantakisha: 2017

Zambia: SA

Adults ≥ 15 years

CS

445 (445)

TDF containing

−

18 months

Cross sectional

CrCl

Cournil: 2016

Cameroon, Burkina Faso, senegal

Adults

RCT

438 (306)

A: TDF + FTC + LPV/r (152); C: TDF + FTC + darunavir (DRV)/r (154)

B: ABC + ddI + LPV/r

18 months on 2nd line

18 months

eGFR (MDRD)

De Beaudrap: 2010

Senegal: WA

Adults

PC

428 (40)

TDF-containing

Non-TDF

pts initiating on ART

42 months

eGFR using CG and MDRD

Chadwick: 2015

Ghana: WA

Adults

CSO

330 (101)

TDF containing

Either AZT or D4T + NVP or EFV

≥ 6 months, 20 months median time for TDF

Cross sectional

CrCl using CG, dipstick proteinuria, uPCR, uACR, uAPR, fractional phosphate and urate excretion. TD defined as having ≥ 2 of: fractional phosphate excretion > 18%, fractional urate excretion > 15%, normo-glycaemic glycosuria, proteinuria (uPCR > 20 mg/mmol) with uAPR < 0.4

Banda: 2010

Zambia; adults

Adults

CS

300 (52)

TDF containing

D4T (3), AZT (6), HIV- (158)

Not stated

Cross sectional

RD defined as rise of sCr to 1.5 × upper limit of normal i.e. ≥ 180 umol/L

Orluwene: 2015

Nigeria: WA

≥ 16 years

PCC

254 (100)

100 TDF based

102 Non-TDF. 52 Rx naïve

…

…

Urinary interleukin (Il)-18, eGFR by CG/MDRD/CKI-Epi

Mpondo: 2014

Tanzania; EA

Adults

RC

238 (54)

54 TDF

184

–

Median 2 yrs

eGFR by CG/MDRD

Agbaji: 2011

Nigeria; WA

Adults

OC

186 (84)

TDF containing

Non TDF

≥ 48 weeks

> 48 weeks

sCr and CrCl using CG

Fritzsche: 2017

Cameroon; WA

Adults

CS

179 (119)

TDF containing

ART naïve pts

Mean period of 301 ± 193 days

Cross sectional

Urinary dipstick for proteinuria, sCr, eGFR using CKD-EPI. Kidney size and structure by ultrasound, renal echogenecity grading as described by Garko

Seedat: 2017

South Africa: SA

≥ 15 years

PC

175 (93)

93 TDF exposed,

TDF unexposed

…

Duration of hospitalisation.

AKI by (KDIGO) 2012 Clinical Practice AKI Guideline. sCr eGFR by MDRD

Kalemeera: 2016

Namibia: SA

Adults

RC

71 (71)

Second line TDF containing ART.

–

Mean 5.2 years on 1st line, 1.8 years on 2nd line

Cross sectional

CrCl. Renal function categories based on CG

Gajee: 2016

South Africa: SA

Adults 20–40

RC partial prospective

66 (66)

TDF containing

–

12 months

12 months

eGFR by CG at before TDF commencement and 12 months post-TDF commencement.

Tewogbade: 2010

Nigeria;WA

Adults

PC

55 (19)

TDF + 3TC + EFV. or as truvada

D4T or AZT

initiating ART

12 months

CrCl (MDRD), eGFR by CG

Mulubwa: 2016

South Africa: SA

Adult women

CS

30 (30)

300 mg TDF nocte

30 HIV uninfected

–

Cross sectional

eGFR (MDRD), CrCl by CG

  1. Designs: OC observational cohort, RC retrospective cohort, PC prospective cohort, CS cross sectional, RCT randomized control trial, TSR targeted spontaneous reporting, PCC prospective Case Control Regions of Africa: CA Central Africa, EA Eastern Africa, SA Southern Africa, WA West Africa