What Your Doctor May Not Be Telling You About Kaletra
Many patients suffering from HIV infection and AIDS have been helped, had their life expectancy greatly improved and been saved by advances in medication. If you have HIV, you or your doctor may be considering Kaletra as part of your treatment.
What is Kaletra? What does Kaletra do?
Kaletra is an antiviral medication for the treatment of HIV-1 infection in adults and children 14 days and older. It is a combination of two drugs, Lopinavir and Ritonavir.1 Kaletra blocks an HIV enzyme, which prevents the virus from copying itself and spreading, and reduces the amount of the virus in the blood.2
Didn’t Magic Johnson recommend Kaletra?
He did, but the FDA considered a 2009 DVD created by Abbott Laboratories and featuring Johnson to be misleading advertising, and warned Abbott to stop using it to promote the drug.
The FDA charged that the Magic Johnson video downplayed and omitted required information warning patients about the side effects of the drug, some of which are fatal. It also found that Abbott’s video “misleadingly overstate[d] the efficacy of Kaletra” and implied that the usual experience of a patient taking Kaletra would be a normal life – physically, sexually, at work – for at least five years.
Abbott Labs had also included an older version of the package insert with this video, which did not list updated important safety information about Kaletra’s use by pediatric patients, including some side effects, which may be fatal in infants.3
Does Kaletra work?
Patients have rated Kaletra’s effectiveness highly in online patient forums.4 Studies have shown Kaletra to be an effective treatment of HIV and that it significantly reduced viral loads in patients, in many cases more than 50%. However, a percentage of patients, as much as 37%, did not experience this reduction in their viral load.5
A 2007 study showed Kaletra to be effective in reducing viral loads in patients in long-term monotherapy, when it was the only drug therapy.6 Kaletra has shown effectiveness in reducing viral loads in children ages 6-12 in about the same proportion as adults. 7
Some patients who have been previously treated with other protease inhibitors have shown some resistance to Kaletra.8 Kaletra does not cure AIDS or HIV infection and there is no information that it prevents or reduces the risk of passing HIV infection to other people. 9
What should I go over with my doctor before I decide to take Kaletra?
Kaletra has a number of side effects, many of them serious, and dangerous interactions may occur if you take Kaletra with other medications. You should learn about each of these side effects, not just some of them, before you decide to take this medicine.
What if I’m already taking Kaletra?
Discuss any concerns you have about your care and any symptoms you may have while taking Kaletra with your doctor. Never stop taking a prescription medication without talking to your doctor. Your doctor can help you weigh the possible dangers and benefits of taking Kaletra and whether it is the best medication for you.
Learn everything you can about Kaletra before you start taking it.
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1 Food and Drug Administration, Drug Safety and Availability, “Kaletra (lopinavir/ritonavir) Information,” http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm246021.htm
2 FDA Drug Info (retrieved 31 July 2012) http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=3188
3 Food and Drug Administration, Division of Drug Marketing, Advertising and Communications Warning Letter to Abbott Laboratories re: Kaletra (14 July 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM173184.pdf
4 WebMD Patient forums, (retrieved 31 July 2012) http://www.webmd.com/drugs/drugreview-19939-kaletra+oral.aspx?drugid=19939&drugname=kaletra+oral&monoId=4294&monoTitle=LOPINAVIR/RITONAVIR%20CAPSULES%20-%20ORAL
5 http://www.aidsmap.com/Effectiveness/page/1731084/#ref1021523; Negredo, et al. JAIDS Journal of Acquired Immune Deficiency Syndromes, (January 2005), “Lopinavir/Ritonavir Plus Nevirapine as a Nucleoside-Sparing Approach in Antiretroviral-Experienced Patients (NEKA Study)” http://www.natap.org/2005/HIV/011805_01.htm
6 Pulido, F., et al. Journal of Antimicrobial Chemotherapy (2008), http://jac.oxfordjournals.org/content/61/6/1359.full.pdf
7 FDA Drug info, (revised July 2008),“KALETRA,” http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=9642#section-15.3
8 FDA Drug Info http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=3579
9 NIH AIDSinfo Drug Database, “Lopinavir/ritonavir,” http://aidsinfo.nih.gov/drugs/316/kaletra/patient/