Page 47 - UNAM Virtual Graduation 2020 e-Book

FACULTY OF HEALTH SCIENCES
SCHOOL OF PHARMACY

DOCTOR OF PHILOSOPHY IN PHARMACY PRACTICE AND
POLICY (PHARMACOEPIDEMIOLOGY)
CANDIDATE: KALEMEERA Francis

CURRICULUM VITAE

After completion of his BPharm degree, Francis worked as a community pharmacist
from where he took on a post of a clinical pharmacist at the AIDS Treatment
Information Centre (ATIC) of the Infectious Disease Institute, Makerere University
Kampala. He became the team leader of the centre. He completed his MSc in
Clinical Pharmacy while at the ATIC. He then took a post of Senior Program associate with Management Sciences
for Health (MSH) in Namibia, under the Strengthening Pharmaceutical Systems project. Further, he took on the post of
Senior Technical Advisor in MSH during the Systems for Improved Access to Pharmaceuticals and Services program.
With MSH, Francis worked closely with the Ministry of Health and Social Services: Namibia in the area of Therapeutics
Information and Pharmacovigilance. From there, Francis joined the Faculty of Health Sciences at UNAM as a lecturer
in pharmacology, clinical pharmacy, pharmacoepidemiology and pharmacovigilance. He now occupies the position
of senior lecturer, while he is the head of department of Pharmacology and Therapeutics at UNAM. He is a member of
the Pharmaceutical Society of Namibia, Pharmaceutical Society of Uganda, and an Associate member of the Royal
Pharmaceutical Society of Great Britain. He has served on the clinical committee of Namibia’s Medicine Regulatory
Council, on the Adverse Events Following Immunisation Committee, and on the Technical Working Group for the
National Action Plan against antimicrobial resistance. His research interest is in the area of pharmacoepidemiology,
particularly on drug safety surveillance, with the purpose of ensuring patient safety.
CANDIDATE’S DISSERTATION

THE RENAL SAFETY OF TENOFOVIR DISOPROXIL FUMARATE-CONTAINING ANTERETROVIRAL THERAPY IN NAMIBIA

The doctoral study was undertaken and completed under the supervision of Professor Timothy William Rennie of the
University of Namibia as Main-Supervisor and Professor Andy Stergachis from the University of Washington as Co-
Supervisor.

Antiretroviral therapy (ART) has tremendously reduced HIV-related morbidity and mortality. However, antiretroviral
drugs (ARV) are associated with serious adverse drug reactions (ADR). Tenofovir Disoproxil Fumarate has been reported
to cause nephropathy, but there has been conflicting evidence regarding the risk factors for TDF-related nephropathy.
For Namibia, the prevalence and risk factors for TDF-associated nephropathy have not been evaluated. Therefore,
this research was conducted to address these information gaps. Three studies were conducted to (1) estimate the
incidence of TDF-associated nephrotoxicity and chronic kidney disease (CKD), (2) evaluate the risk factors therein;
and (3) assess the renal function outcomes in patients with a creatinine clearance (CrCl) less than 60 ml/min. The
studies were retrospective in nature with data from the electronic Patient Management System (ePMS). The incidence
of TDF-associated nephrotoxicity was estimated with the OpenEpi calculator. Odds ratios (OR) were generated for
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risk factors. The effect of low baseline CrCl (60 ml/min) on renal function following TDF-containing ART was assessed.
The relationship between TDF and new-onset CKD was assessed, with the incidence rate (IR) estimated using the
OpenEpi . CKD risk factors were identified by OR’s generated by binary logistic regression and the Cox-Proportional
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Hazard methods. For all studies the confidence interval was set at 95% and the statistical significance at less than 0.05.
Of 599 patients, 19.7% experienced decline in renal function, with an IR of 25.5 per 100 patient years (CI: 21.2 – 30.4 per
100 patient years; p<00.001). Female gender and duration of ART were associated with these ORs, respectively: 29.5
(12.1 - 71.9, p<00.001) and 1.32 (12.6 – 54.9, p=00.001). Of 389 patients with a baseline CrCl less than 60 ml/min, 37.0%
experienced improvement in renal function, 1.3% experienced a decline. A higher baseline CrCl was associated with
less likelihood of improvement in CrCl: 0.897 (0.859 – 0.956, p <00.001), and a longer duration of exposure to ART was
not associated with any improvement in CrCl: 0.904 (0.880 – 0.923, p<00.001). The odds of experiencing a rapid decline
in CrCl were 0.412 (0.184 – 0.920, p=0.031). Of 1382 patients new onset CKD was observed in 20.0%, for an IR of 9.8 per
100 patient years. Being female increased the risk of acquiring CKD: 1.691 (1.221 – 2.341, p=0.002). A longer duration
did not have an effect on renal function: 0.962 (0.949 – 0.975, p<00.001). IRs of nephrotoxicity and CKD were high. Risk
factors included female gender and increased duration of exposure to TDF. A low baseline CrCl more likely improved
with TDF-containing ART. TDF may not be withheld from such patients unless the risk outweighs the possible resolution.
Further research is required in Namibia to assess the contribution of factors such as hypertension, diabetes mellitus, and
co-medications on renal function in patients receiving TDF-containing ART.
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