Incidence and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz

Abah, Isaac Okoh; Akanbi, Maxwell O; Abah, Mercy Enuwa; Finangwai, Amos Istifanus; Dady, Christy; Falang, Kakjing D.; Ebonyi, Augustine O.; Okopi, Joseph Anejo; Agbaji, Oche; Sagay, AS; Okonkwo, Prosper; Idoko, John; Kanki, Phyllis J.

doi:10.11599/germs.2015.1075

Cited by 22 publications

(32 citation statements)

References 24 publications

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“…Patients with baseline regimen containing stavudine in the combination were at higher risk of developing adverse drug reactions. This is in agreement with previous literature [15,21,24], and it might be because stavudine is known for its typical side effects such as abdominal fat distribution, peripheral neuropathy, lipoatrophy or lipodystrophy, lactic acidosis or severe hepatomegaly with steatosis, and acute pancreatitis [5,25].…”

Section: Discussionsupporting

confidence: 93%

“…The incidence rate of adverse drug reaction was 3 (95% C.I: 2.4, 3.86) per 100-person years of follow up. This finding is lower than findings from Bahir Dar city (4.3/100 PY) [13], finding from seven teaching hospitals in Ethiopia (9/100 PY) [14], two retrospective studies from Nigeria (4.6/100 PY and 4.05/100 PY) [15,16] and another study in Ethiopia [8]. This lower figure might be related to the difference in follow up duration in which all of these previous studies had a shorter duration than the current study.…”

Section: Discussioncontrasting

confidence: 61%

“…About 13.81% (95% C.I: 10.87%, 17.2%) of the cohort had experienced ADR. This figure is higher than findings from Bahir Dar city (10%) [13], a tertiary hospital in Addis Ababa (7.7%) [17], seven teaching hospitals in Ethiopia (9.5%) [14], Nigeria (1.4%) [15,16], a tertiary hospital in Ghana (9.4%) [18] and India (2.4%) [19]. The difference might be due to the longer follow up time in the current study which can be explained by the longer the follow-up, the higher the probability of including the ADR [21] and Kenya where it accounted for 66.3% [22].…”

Section: Discussioncontrasting

confidence: 58%

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Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Kibret

Ayele

Tesfahun

2019

Preprint

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Background: Due to its nature of chronicity and the trend of using more drugs for patients with HIV, antiretroviral toxicity becomes a major challenge of HIV management. Evidences revealed that magnitude of experiencing at least one form of drug toxicity in different setting have been reached up to 90% among patients on antiretroviral therapy. The main aim of this study was to estimate the incidence and predictors of severe adverse drug reactions among People Living with Human Immunodeficiency Virus (PLHIV) at Debre Markos Referral Hospital. Methods: Retrospective follow up study with survival analysis was carried out among people living with Human Immunodeficiency virus. Mean survival time of the cohort was estimated using Kaplan-Meier method. To model the relationship between explanatory variables and the time to adverse drug reaction, Cox-proportional hazard regression model was fitted. Results: Out of the total 485 participants 67 (13.81%; 95% C.I: 10.7%, 16.8%) had experienced sever adverse drug reactions (ADRs). The incidence rate of severe adverse drug reaction development was 3 per 100-person years. Patients residing out of the catchment area to the facility were 73% at higher risk to develop ADR at any time, compared to those living within the catchment area (AHR=1.73; 95% C.I: 1.04, 2.86). The risk of ADRs among patients with baseline WHO clinical stage of III and IV was 2.59 times higher at any time compared to those with WHO stages I and II (95% C.I: 1.54, 4.36). Conclusion: The incidence of adverse drug reactions was relatively lower than reported in different parts of Ethiopia and other African countries. However, the overall burden in the 10 years period was still high. Health professionals working in the ART clinic need to give special attention for patients coming from outside of catchment areas, commercial sex workers and drivers and patients on advanced WHO clinical stages to prevent ADR development among these groups.

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Section: Discussionsupporting

confidence: 93%

Section: Discussioncontrasting

confidence: 61%

Section: Discussioncontrasting

confidence: 58%

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Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Kibret

Ayele

Tesfahun

2019

Preprint

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“…The incidence rate of adverse drug reaction was 3 (95% C.I: 2.4, 3.86) per 100-person years of follow up. This is lower than findings from Bahir Dar city (4.3/100 PY) [16], finding from seven teaching hospitals in Ethiopia (9/100 PY) [17], two retrospective studies from Nigeria (4.6/100 PY and 4.05/100 PY) [18,19] and another study in Ethiopia [11]. This lower figure might be related to the difference in follow up duration in which all of these previous studies had shorter duration than the current study.…”

Section: Discussioncontrasting

confidence: 54%

Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Kibret¹,

Ayele²,

Tesfahun³

2019

Preprint

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Background Due to its nature of chronicity and the trend of using more drugs for patients with HIV, antiretroviral toxicity becomes a major challenge of HIV management. Evidences revealed that magnitude of experiencing at least one form of drug toxicity in different setting have been reached up to 90% among patients on antiretroviral therapy. Objective The main aim of this study was to estimate the incidence and predictors of severe adverse drug reactions among People Living with Human Immunodeficiency Virus (PLHIV) at Debre Markos Referral Hospital. Methods Retrospective follow up study with survival analysis was carried out among people living with Human Immunodeficiency virus. Mean survival time of the cohort was estimated using Kaplan-Meier method. To model the relationship between explanatory variables and the time to adverse drug reaction, Cox-proportional hazard regression model was fitted. Results Out of the total 485 participants 67 (13.81%; 95% C.I: 10.7%, 16.8%) had experienced sever adverse drug reactions (ADRs). The incidence rate of severe adverse drug reaction development was 3 per 100-person years. Patients residing out of the catchment area to the facility were 73% at higher risk to develop ADR at any time, compared to those living within the catchment area (AHR=1.73; 95% C.I: 1.04, 2.86). The risk of ADRs among patients with baseline WHO clinical stage of III and IV was 2.59 times higher at any time compared to those with WHO stages I and II (95% C.I: 1.54, 4.36). Conclusion The incidence of adverse drug reactions was relatively lower than reported in different parts of Ethiopia and other African countries. However, the overall burden in the 10 years period was still high. Health professionals working in the ART clinic need to give special attention for patients coming from outside of catchment areas, commercial sex workers and drivers and patients on advanced WHO clinical stages to prevent ADR development among these groups.

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“…A study from Nigeria of 2920 HIV infected patients reported an incidence of gynaecomastia of 10.7 per 100 person years over 8 years [16]. …”

Section: Discussionmentioning

confidence: 99%

Cases of antiretroviral-associated gynaecomastia reported to the National HIV & Tuberculosis Health Care Worker Hotline in South Africa

et al. 2016

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BackgroundGynaecomastia is associated with exposure to antiretroviral therapy (ART), in particular efavirenz. There is limited data on clinical characteristics of patients with ART-associated gynaecomastia in resource-limited settings and little guidance on the optimal management of this adverse drug reaction (ADR). We describe the clinical characteristics, management and outcomes of gynaecomastia cases reported to the National HIV & Tuberculosis Health Care Worker Hotline in South Africa.MethodsWe identified all gynaecomastia cases in adolescent boys and men on ART reported to the hotline between June 2013 and July 2014. We collected follow up data telephonically at monthly intervals to document clinical management and outcomes.ResultsWe received 51 reports of gynaecomastia between June 2013 and July 2014; 11% of the 475 patient-specific ADR queries to the hotline. All patients were on efavirenz-based ART. Mean age was 34 years (standard deviation 12) and seven were adolescents. The median onset of gynaecomastia was 15 months after efavirenz initiation (interquartile range 6–42). Gynaecomastia was bilateral in 29 patients (57%) and unilateral in 16 (31%). Serum testosterone was quantified in 25 of 35 patients with follow up data, and was low in 2 (8%). Efavirenz was replaced with an alternative antiretroviral in 29/35 patients (83%) and gynaecomastia improved in 20/29 (69%).ConclusionsGynaecomastia was a frequently reported ADR in our setting, occurring with prolonged efavirenz exposure. Testosterone was low in the minority of tested cases. Most clinicians elected to switch patients off efavirenz, and gynaecomastia improved in the majority.

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Incidence and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz

Abstract: Introduction Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (

Cited by 22 publications

References 24 publications

Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Incidence and Predictors of Sever Adverse Drug Reactions Among Patients on Antiretroviral Therapy at Debre Markos Referral Hospital, Northwest Ethiopia

Cases of antiretroviral-associated gynaecomastia reported to the National HIV & Tuberculosis Health Care Worker Hotline in South Africa

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