A farewell to didanosine: harm reduction and cost savings by eliminating use of didanosine

Abstract

Didanosine (ddI) is a nucleoside reverse transcriptase inhibitor associated with adverse events and public health concerns which have diminished its place in clinical practice, particularly in resource-rich settings. While international guidelines do not contain ddI-containing regimens in preferred first- or second-line antiretroviral therapy (ART), there is no guidance for management of patients currently on ddI. In 2012 at least 20 countries purchased a total of $1–2 million of ddI. Drug purchase data in that year show 3.2–10.3 times higher costs for ddI compared to lamivudine (3TC). Given issues of multiple toxicities, monitoring, drug interactions, inconvenience, and virologic efficacy, as well as cost and formulary concerns, national (including resource-limited setting) ART programs should consider complete phase-out of ddI.

Didanosine-Associated Retinal Toxicity (DART) Amongst HIV-Positive Patients: a Case Series and Literature Review

“…DDI is a purine (adenosine) analogue NRTI first approved for use in 1991 [3] for the treatment of HIV-positive patients in combination with other antiviral medication as part of HAART. HAART utilises dual class, triple combinational therapy, usually 2 nucleoside/non-nucleoside reverse transcriptase inhibitors and 1 protease inhibitor (e.g.…”

“…In 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set the ambitious target of 90-90-90, aiming for 90% of all HIV-positive patients to be diagnosed, 90% to be on sustained ART and 90% to have effective viral suppression by 2020 [2]; it is therefore clear that ART use will be widespread and sustained. Didanosine (DDI), a nucleoside reverse transcriptase inhibitor (NTRI), was first synthesised in 1964 as an anticancer drug but gained approval for use as an antiretroviral agent for the treatment of HIV by the Federal Drug Administration (FDA) in the USA in 1991 [3]. Between 2002 and 2006, the World Health Organization (WHO) recommended DDI to be used as the second-line ART treatment for HIV-positive patients [3].…”

“…Didanosine (DDI), a nucleoside reverse transcriptase inhibitor (NTRI), was first synthesised in 1964 as an anticancer drug but gained approval for use as an antiretroviral agent for the treatment of HIV by the Federal Drug Administration (FDA) in the USA in 1991 [3]. Between 2002 and 2006, the World Health Organization (WHO) recommended DDI to be used as the second-line ART treatment for HIV-positive patients [3]. However, the 2013 WHO consolidated ART guidelines did not recommend DDI as a first-or second-line ART agent due to toxicity concerns [3].…”

“…Between 2002 and 2006, the World Health Organization (WHO) recommended DDI to be used as the second-line ART treatment for HIV-positive patients [3]. However, the 2013 WHO consolidated ART guidelines did not recommend DDI as a first-or second-line ART agent due to toxicity concerns [3]. The FDA issued updated safety alerts for DDI-induced fatal pancreatitis and lactic acidosis in 2002 and DDI-induced non-cirrhotic portal hypertension in 2010 [3].…”

“…However, the 2013 WHO consolidated ART guidelines did not recommend DDI as a first-or second-line ART agent due to toxicity concerns [3]. The FDA issued updated safety alerts for DDI-induced fatal pancreatitis and lactic acidosis in 2002 and DDI-induced non-cirrhotic portal hypertension in 2010 [3]. While in most developed countries DDI has been substituted with other antiretroviral drugs, despite the reported concerns, in 2012, at least 20 countries purchased a total of 1 to 2 million US dollars' worth of DDI, which is 3 to 10 times the cost of the preferred second-line agent lamivudine [3].…”