WARNING: treatment news
Double check you are taking the right dose of your meds...
Robert Fieldhouse
The week before going to print, BASELINE received reports from two leading UK HIV activists who had not been informed about recent dosing changes to their meds. Both have spent months overdosing on HIV drugs.
Rosy Weston, Lead HIV/GUM pharmacist at St Mary’s Hospital in London told BASELINE, “New dosing recommendations, as in the case of oncedaily dosing of darunavir with 400mg tablets and new formulations, are common in HIV medicine. Ideally all dose and presentation changes should be discussed with individuals during their clinic appointment as well as the dispensing process. “In the case of both atazanavir and darunavir a special information sheet was produced by the manufacturers of atazanavir (Bristol-Myers Squibb) and HIVPA (HIV Pharmacists Association on darunavir to be given out during dispensing to explain the changes.” In one case, the activist has said that the home delivery of her medicines may have played a part in the mix up. 36
A once-daily dose of the protease inhibitor darunavir 800mg (Prezista) was as effective at suppressing HIV viral load as a 600mg twice-daily dose in treatment-experienced patients without pre-existing resistance mutations to darunavir. It was also less likely to cause lipid disturbances.
Rosy Weston reassured BASELINE, “HIVPA does work closely with the home delivery providers to inform them of any planned changes.” The second activist who collects her meds from clinic said neither her doctor nor the pharmacist mentioned that atazanavir had been reformulated and that she should take one pill instead of two. “I just kept getting more and more yellow but took solace from the fact that Alexander McQueen had sent models wearing yellow contact lenses down the catwalk.” Sarah Barber, an HIV specialist nurse at Beckenham hospital in Kent said “Sometimes people get it wrong from the start; taking the first month of meds and thinking the course is finished. My advice is always make sure you have got your prescription renewed even if it doesn’t coincide with your clinic appointment and double check dosing with pharmicist or nurse.” Neither St Mary’s nor Beckenham Hospital were involved in the mix ups.
Life expectancy normal diagnosed today, perhaps
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All patients took darunavir along with two active nucleoside reverse transcriptase inhibitors (NRTIs). Discontinuation rates were similar; 13.9% (oncedaily) and 16.2% (twice-daily).
People who are recently diagnosed or who have high CD4 counts when they start treatment can expect to live a normal or near normal lifespan. Dutch researchers have followed patients diagnosed between 1998 and 2007 and measured their death rate over the next 3 years. This allowed them to make predictions regarding life expectancy. Someone diagnosed today aged 25 could expect to live for 52.7 more years. This is barely different to the Dutch national average of 53.1 years. The predictions rely on HIV drugs continuing to work, and do not apply to the large proportion diagnosed late.
At week 48, 72.1% of those taking once-daily darunavir had a viral load below 50 copies/mL, compared to 70.9% of those taking the drug twice daily.
New CCR5 antagonist likely for first therapy
The trial included 590 treatment-experienced patients.
Two leading UK HIV activists overdosed on meds
One activist reported taking twice the dose of the protease inhibitor atazanavir (Reyataz) for six months; the other took 1200mg of darunavir (Prezista 3 tablets once daily) for ten months. The story highlights the need for everyone with HIV to double check their medicine with a pharmacist, especially if your drugs are being home delivered.
Once-daily darunavir for treatment experienced
CD4 increases were also comparable between those taking the drug once daily or twice daily (100 cells/mm3 vs. 94 cells/mm3). The proportion of patients discontinuing because of side-effects was similar between the two groups (3.4% vs. 4.1%). But once-daily dosing appeared to be better from a lipid point of view; with fewer grade 2-4 elevations in triglycerides (5.2% vs. 11.0%), total cholesterol (10.1% vs. 20.6%) and LDL cholesterol (9.8% vs. 16.7%). Liver toxicity was also slightly less common with once-daily dosing.
Drug giant Merck, Sharpe & Dohme (MSD) has indicated that it will not submit a new drug application to licensing authorities for vicriviroc for treatment-experienced individuals. Vicriviroc failed to work better than a potent background regimen of three active drugs that were already working well. This does not mean that vicriviroc is not a potent drug; rather that it is becoming increasingly difficult for new drugs to show additional efficacy over and above what existing licensed medicines can achieve. This is even true among people who have been treated for many years and who have high levels of drug resistance. Vicriviroc performed well among a group of people who had only had two active HIV drugs in their background regimen, but added no extra value to the treatment of those taking three potent drugs already. Vicriviroc was well tolerated in the study of over 800 patients. It is likely MSD will now focus efforts on studying the drug in people who are starting therapy for the first time and seek a license for first treatment. 37