Adverse Drug Reactions to Nonnucleoside Reverse Transcriptase Inhibitor-Based Antiretroviral Regimen: A 24-Week Prospective Study

Abstract

As the developing world increasingly uses generic ART, the clinician must be constantly vigilant for treatment-related adverse events.

Neuropsychiatric effects of tenofovir in comparison with other antiretroviral drugs

“…70 Neuropsychiatric manifestations most commonly associated with EFV use include dizziness, confusion, lethargy, impaired concentration, amnesia, hallucinations, abnormal dreams, insomnia, sleep disorders, depression, and irritability. 71,72 The CNS symptoms usually appear in the first weeks of therapy and abate within several weeks. [73][74][75][76][77] While the exact mechanism responsible for these neuropsychiatric effects by EFV has not been established, some studies suggest that the CNS side effects are related to the higher level of plasma EFV exposure .…”

Future Perspectives in NNRTI-Based Therapy: Bases for Understanding Their Toxicity

“…Severe life-threatening hepatotoxicity, including fatal fulminant hepatitis, has also been reported during therapy with NVP. In a recent study of NVP patients, 25.7% developed grade 1 hepatotoxicity and 2.8% displayed severe hepatotoxicity (Jena, 2009). There is also conflicting evidence about the involvement of NVP therapy in the progression of liver fibrosis in patients with a concomitant HCV infection, as some studies support this hypothesis (Macías, 2004) whereas others relate NVP to a reduction of fibrosis (Berenguer, 2008).…”

“…There is also conflicting evidence about the involvement of NVP therapy in the progression of liver fibrosis in patients with a concomitant HCV infection, as some studies support this hypothesis (Macías, 2004) whereas others relate NVP to a reduction of fibrosis (Berenguer, 2008). Up to 10% of EFV-treated patients exhibit increases of liver enzymes that may require discontinuation of therapy and which have been associated both with hypersensitivity to EFV and dose-dependent accumulative effects (Angel-Moreno-Maroto, 2006;Jena, 2009;Kappelhoff, 2005;Rivero, 2007). In fact, a substudy of the 2NN trial showed a correlation between the incidence of elevated levels of liver enzymes and plasma concentrations of EFV during the first 6 weeks of treatment.…”

“…On the other hand, DLV is no longer used due to its limited efficacy. First generation NNRTI exhibit a somewhat ineffective genetic barrier to the development of resistance, and have been shown to induce several moderate-to-severe side effects whose frequency and severity vary significantly with each compound, including hepatotoxicity, cutaneous reactions, central nervous system toxicity, metabolic alterations and gastrointestinal adverse events (van den Berg-Wolf, 2008;Jena, 2009). These disadvantages have fuelled the search of new NNRTI with an improved resistance profile and higher efficacy and tolerability, such as Etravirine (ETR), which was approved by the FDA in 2008 (Martínez, 2010) …”

A retrospective study to evaluate the pattern of spontaneously reported antiretroviral induced adverse drug reactions in a tertiary care hospital

“…4 Although the primary therapeutic goals of ART are to achieve and maintain viral suppression and improve patient immune function, among the secondary goals should be to select a safe and effective regimen, taking into account individual patients, underlying conditions, concomitant medications, and history of drug intolerance. 5 In India, the National AIDS Control Organization (NACO) introduced inexpensive and generic ART drugs. 6 So, with the availability of generic HAART at low cost, an increasing number of HIV-infected individuals in India are now receiving therapy.…”