Once daily d4T on horizon

This article is more than 23 years old.

A new extended release formulation of d4T (stavudine), dosed

once daily, is just as potent as twice daily d4T and may result in fewer side

effects, according to results of a 48 week study presented at the Eighth

Glossary

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

trend

In everyday language, a general movement upwards or downwards (e.g. every year there are more HIV infections). When discussing statistics, a trend often describes an apparent difference between results that is not statistically significant. 

treatment-naive

A person who has never taken treatment for a condition.

absorption

The process (or rate) of a drug or other substances, such as food, entering the blood.

toxicity

Side-effects.

European Conference on Clinical Aspects of Treatment of HIV Infection.

The study, presented by Dr Julio Montaner of the University

of British Columbia, Vancouver, involved 150 treatment-naïve patients who were

randomized to receive treatment with a triple regimen of efavirenz, 3TC and

either standard d4T or extended release d4T (at a dose of 100mg a day in those

weighing over 60kg, and 75mg a day in those weighing less than 60kg). 3TC was

dosed twice daily in this study.

Median baseline viral load was 49,000 copies in the extended

release arm and 42,600 in the twice daily arm. After 48 weeks, the proportions

with viral load below 50 copies were 50% and 49% respectively by intent to

treat analysis, although the discontinuation rate was twice as high in the

twice daily arm (18% vs 9%). This was driven largely by non-adherence and

adverse events. There were no significant differences in adverse events, but a

trend was apparent towards more cases of peripheral neuropathy in the twice

daily arm (11% vs 1%).

Implications

These data do not show that taking the current d4T formulation on a once daily basis is safe. The once daily, extended release formulation used in this study is different from the capsules dosed twice daily because it is absorbed less well, according to Dr Andrew Clark of BMS Pharma. Once daily dosing of the current formulation may not be safe and may result in a higher rate of toxicity, so patients should not consider changing their dosing pattern of current d4T capsules on the basis of this study.

Bristol Myers Squibb Pharma, manufacturer of d4T, is likely

to pursue a once daily license for the drug in 2002, and will carry out

studies looking at interactions with other drugs. The company will also study

how food affects the absorption of the drug in more detail, in order to define

what sort of meal the extended release formulation should be taken with. It is probable that an expanded access programme that makes the drug available for patients who have adherence difficulties and who would benefit from a once daily regimen will be set up before the drug is licensed.