An ongoing dialogue on HIV/AIDS, infectious diseases,
February 11th, 2010
Ritonavir Tablet Approved
It’s not on Abbott’s web site yet (update: now it’s here), but the FDA has approved a new formulation of ritonavir — a heat-stable 100 mg tablet. From an e-mail release by the FDA:
On February 10, 2010, FDA approved Norvir (ritonavir) 100 mg Tablets. These tablets do not require refrigeration. Unlike the capsule formulation [pictured], Norvir tablets must be taken with meals.
–snip–
NORVIR tablets are not bioequivalent to NORVIR capsules. Under moderate fat conditions (857 kcal; 31% fat, 13% protein, 56% carbohydrates), when a single 100 mg NORVIR dose was administered as a tablet compared with a capsule, AUC(0- ∞) met equivalence criteria but mean Cmax was increased by 26% (92.8% confidence intervals: ↑15 -↑39%).
This is obviously an advance — the Norvir soft-gel capsule is much-despised for a variety of reasons, one of the most notable being the glob of melted capsules that results if the medication is left in the car, in a warm room in the summertime, near a radiator, etc. When Kaletra switched from capsule to tablet, the heat-stability was a big improvement in convenience, and also made treatment in resource-limited settings much easier.
Time will tell if the increase in peak levels has any effect on tolerability, a potential concern since much of ritonavir’s toxicity is dose-related. I suspect Abbott will have both formulations available for a while until this is sorted out.
And for those who still have patients still on 600 mg twice-daily — it’s time to switch to something else!
since there are a lot of medicin for HIV, what is the best combination, efficient medicin for HIV in 2010?
appreciate a lot you reply.
please advise
m,
The latest DHHS Guidelines provide a very nice summary — check the “Preferred” regimens, summarized in Table 5a:
http://www.aidsinfo.nih.gov/Guidelines/GuidelineDetail.aspx?MenuItem=Guidelines&Search=Off&GuidelineID=7&ClassID=1