Leveraging Experience From Active TB Drug-Safety Monitoring and Management for Monitoring Active Antiretroviral Toxicity

Lisa Stevens; Kelly E. Perry; Iakuna Moide; Francil Kaemala; Justine Nankinga; Anh L. Innes; Ignatius Mogaba

doi:10.9745/GHSP-D-21-00595

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FIGURE 1
Generic Model of aDSM Within Drug-Safety Structures at the National Level
Abbreviations: aDSM, active drug safety monitoring and management; PMDT, programmatic management of drug resistant TB; NTP, national TB program.
Adapted from the World Health Organization Framework for aDSM Implementation.²²
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FIGURE 2
Data Collection and Reporting Process for Active Toxicity Monitoring for New ARV Drugs
Abbreviations: ART, antiretroviral therapy; ARV, antiretroviral; WHO, World Health Organization.
Adapted from the World Health Organization Implementation Tool for Monitoring the Toxicity of New Antiretroviral and Antiviral Medicines in HIV and Viral Hepatitis Programmes.³¹

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TABLE 1.

Data and Specificity Captured by Active Toxicity Monitoring Versus Routine Toxicity Monitoring^{^a}

Data Element	Routine Toxicity Monitoring	Active Toxicity Monitoring
Management of adverse drug reactions	Partially (drug substitutions resulting from toxicity captured)	Yes
Seriousness of adverse drug reactions	No	Yes
Outcome of adverse drug reactions (resolved, requires, or prolongs hospitalization, disability, death, etc.)	No	Yes

↵a Described in the World Health Organization Implementation Tool for Monitoring the Toxicity of New Antiretroviral and Antiviral Medicines in HIV and Viral Hepatitis Programmes.³¹

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TABLE 2.

Major Antiretroviral Toxicities Described in the WHO Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Prevention HIV Infection 2016³⁸

Antiretroviral Drug	Toxicity
Abacavir	Hypersensitivity reaction
Atazanavir/r	Electrocardiographic abnormalities (PR and QRS interval prolongation) Indirect hyperbilirubinemia (clinical jaundice) Nephrolithiasis
Zidovudine	Severe anemia, neutropenia Lactic acidosis or severe hepatomegaly with steatosis Lipoatrophy Lipodystrophy Myopathy
Darunavir/r	Hepatotoxicity Severe skin and hypersensitivity reactions
Dolutegravir	Hepatotoxicity Hypersensitivity reactions
Efavirenz	Persistent central nervous system toxicity (such as dizziness, insomnia, abnormal dreams) or mental symptoms (anxiety, depression, mental confusion) Convulsions Hepatotoxicity Severe skin and hypersensitivity reactions Gynecomastia Severe skin and hypersensitivity reactions
Lopinavir/r	Electrocardiographic abnormalities (PR and QRS interval prolongation, torsades de pointes) Hepatotoxicity Pancreatitis Dyslipidemia Diarrhea
Nevirapine	Hepatotoxicity Severe skin rash and hypersensitivity reaction, including Stevens-Johnson syndrome
Raltegravir	Rhabdomyolysis, myopathy, myalgia Hepatitis and hepatic failure Severe skin rash and hypersensitivity reaction
Tenofovir Disoproxil Fumarate	Chronic kidney disease Acute kidney injury and Fanconi syndrome Decreases in bone mineral density Lactic acidosis or severe hepatomegaly with steatosis