The clinical benefits of didanosine
for certain patients with HIV continue to outweigh its potential risks," but the decision to prescribe the drug "must be made on an individual basis between the treating physician and the patient," the FDA said.
Although clinical studies showing marginal efficacy of didanosine
monotherapy were used to get approval for the drug's registration, monotherapy is no longer considered optimal use of this or any antiretroviral drug.
Thirty-five percent of patients had at least one morphologic change, but researchers noted that prevalence at 30 months was twice as high in the group randomized to the stavudine and didanosine
arm than in the groups assigned to the other NRTI combinations (Abstract 19).
Interestingly, the use of abacavir, but not of didanosine
, was associated with higher baseline levels of the inflammatory biomarkers hsCRP and IL-6.
Of these, 4 were excluded: a 27-year-old woman with sepsis, haemolytic anaemia and jaundice; a 23-year-old woman with diarrhoea; a 30-year-old woman with a history of lactic acidosis in 2003 on dual regimen didanosine
and stavudine (she interrupted therapy for 11 months, was recommenced on stavudine, and died from Pneumocystis jirovecii pneumonia immune reconstitution inflammatory syndrome); and the fourth patient because no clinic records were found.
They were then grown in the presence of Ubisol-Aqua(TM): Coenzyme Q10 plus stavudine and Ubisol-Aqua(TM): Coenzyme Q10 plus didanosine
For those beginning antiretrovirals, the guidelines now say that the combination of an NNRTI + didanosine
plus tenofovir should not be used, due to virologic failure and development of resistance.
labeling states that the dose of ddI should be reduced when co-administered with tenofovir because of increased risks of ddI toxicity, including pancreatitis.
Bristol-Myers Squibb sends a warning letter to healthcare providers regarding pancreatitis with the NRTI didanosine
For example, didanosine
and stavudine concentrations drop to subtherapeutic levels when these drugs are taken with methadone.
In December 2004, the FDA approved a generic version of Didanosine
(ddl) Delayed Release capsules (200 mg, 250 mg, and 400 mg) to use in combination with other HIV needs to treat adults with HIV.
Severe hepatotoxicity occurred in patients on zidovudine (ZDV), lamivudine (3TC), or nevirapine (NVP) and with antiretroviral regimens containing didanosine
(ddI) or stavudine (d4T).
We report a case of fatal NRTI-induced lactic acidosis that occurred 4 months after stavudine, didanosine
, and tenofovir were initiated.
Thai AIDS activists had sued to challenge the validity of a patent on the formulation of didanosine
(ddI), used as a component of the lifesaving drug cocktail for people with AIDS.
Seven patients were receiving a stavudine-containing regimen, and one was receiving a combination of stavudine and didanosine