Page 173 - HIV/AIDS Guidelines

Adverse Effects of Antiretroviral Agents (Last updated March 27, 2012; last reviewed March 27,
2012)
Adverse effects have been reported with use of all antiretroviral (ARV) drugs and are among the most
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common reasons for switching or discontinuing therapy as well as for medication nonadherence. Rates of
treatment-limiting adverse events in antiretroviral therapy (ART)-naive patients enrolled in randomized trials
appear to be declining with use of newer ARV regimens and are generally now occurring in less than 10% of
study participants. However, most clinical trials have a relatively short follow-up duration and can
underestimate longer term complications of therapy. In the Swiss Cohort study, the presence of laboratory
adverse events was associated with higher rates of mortality during 6 years of follow-up, highlighting the
importance of adverse events in overall patient management. 2

Several factors may predispose individuals to adverse effects of ARV medications. For example, compared
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with men, women (ART-naive women with CD4 counts >250 cells/mm ) seem to have a higher propensity of
developing Stevens-Johnson syndrome, rashes, and hepatotoxicity from nevirapine (NVP) 3-5 and have higher
rates of lactic acidosis from nucleoside reverse transcriptase inhibitors (NRTIs). 6-8 Other factors may also
contribute to the development of adverse events: concomitant use of medications with overlapping and
additive toxicities; comorbid conditions that may increase the risk of or exacerbate adverse effects (e.g.,
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alcoholism or coinfection with viral hepatitis, which may increase risk of hepatotoxicity 10-12 ); drug-drug
interactions that may lead to an increase in drug toxicities (e.g., interactions that result from concomitant use
of statins with protease inhibitors [PIs]); or genetic factors predisposing patients to abacavir (ABC)
hypersensitivity reaction (HSR). 13-14
Although the therapeutic goals of ART include achieving and maintaining viral suppression and improving
immune function, an overarching goal should be to select a regimen that is not only effective but also is safe.
This requires consideration of not only the toxicity potential of an ARV regimen but also an individual
patient’s underlying conditions, concomitant medications, and prior history of drug intolerances.
In addition, it should be appreciated that in general the overall benefits of HIV therapy outweigh its risks and
that some conditions such as anemia, cardiovascular disease (CVD), and renal impairment may be more
likely in the absence of ART. 15-16
Information on adverse events is outlined in multiple tables in the guidelines. Table 13 provides clinicians
with a list of the most common and/or severe known ARV-associated adverse events listed by drug class.
Appendix B, Tables 1–6 summarize the most common adverse effects of individual ARV agents. Some
approaches to the management of complications of ART have been published and will not be discussed in
these tables. 17-20

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents K-7

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