People taking Kaletra (lopinavir/ritonavir) prefer the new tablet version - taken once a day - over the soft gel capsules taken twice a day according to data from a small US study presented at the recent Eighth International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV in San Francisco.
Until recently Kaletra was supplied as a soft-gel capsule and three were taken twice daily with meals. The capsules also had to be kept refrigerated.
The new tablet formulation was approved in the United States in October [2005] and recently became available in Europe. The recommended dose in treatment-naïve patients is two tablets twice daily or four tablets once daily with or without food. The tablets do not need to be refrigerated.
Once -daily administration of Kaletra is not recommended in treatment-experienced patients.
It is hoped that the once-daily tablet formulation might improve treatment compliance and reduce the problem of diarrhoea some patients experience with the gel capsules.
This study involved giving multiple choice questionnaires to 332 HIV-infected people who were taking the soft get Kaletra and then switched to the tablet. Respondents were recruited through 52 HIV physician’s practices in the United States. The study was sponsored by the drug's manufacturer, Abbott Laboratories.
Respondents were overwhelmingly male (85%), over 35 years of age (87%) and with lengthy experience of HIV therapy (more than five years: 59%). Eighty-two per cent had been taking Kaletra soft-gel capsules for at least one year, and 89% had switched to Kaletra tablets less than three months prior to filling out the questionnaire.
Eighty per cent of those questioned were ‘very’ or ‘extremely’ satisfied with taking Kaletra tablets compared to 60% on soft gel capsules, and 84% felt they had ‘very good’ or ‘great’ tolerability with the tablet compared to 63% with the gel capsule.
Diarrhoea tended to be less of a problem with the new formulation. The proportion of patients reporting no diarrhoea after switching to the tablets more than doubled for those taking the gel capsules twice a day (p
Eighty-two per cent of those taking the tablets reported no or improved diarrhoea, and the proportion reporting no or rare diarrhoea rose after switching to the tablets, although the way in which the investigators reported the changes in diarrhoea frequency is not transparent, except for the statement that the proportion reporting severe diarrhoea fell from 12% with the soft gel capsules to 3% with the tablets.
Adherence improved from 93% to 97% and 15% more respondents had no missed doses after switching from soft-gel capsules to once-daily capsules.
Twelve per cent of people taking the gel capsules said that avoiding side-effects was one of the reasons they missed doses but after switching this was cited as a reason by only 4%, a significant decline (p
Forty-one per cent of those questioned after switching to the tablet form said that no longer having to take them with food was a major benefit, but only 44% indicated that they had taken at least one dose without food in the previous week.
Finally 88% of those questioned said they preferred the tablets over the gel capsules.
The authors say this study is the first to look at tolerability of Kaletra tablets in HIV-infected patients and say the results warrant further study.
Schrader S et al. Switching to lopinavir/ritonavir (LPV/r) tablets once daily from soft-gel capsule dosed BID/QD led to significant improvements in tolerability, diarrhea, antidiarrheal medication use and satisfaction. Eighth International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, 2006.