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Drug Resistance With HIV, the development of resistance refers to a decrease in a medication's ability to fight the HIV virus. This is brought on by genetic changes within the virus called mutations, which happen while the virus is making copies of itself. A genetic mutation doesn't change the way your medication works, it changes the way the virus looks to the medication. If the virus has changed a lot, the medication will not be able to recognize the virus and will not work the way it should. The virus will no longer be vulnerable or "susceptible" to the medication—this is drug resistance. So, if the amount of HIV in the blood is not kept low and in control, the possibility of drug resistance increases greatly, and this can limit the future use of some drugs. Use 1 KALETRA® (lopinavir/ritonavir) is a prescription anti-HIV medicine that contains two medicines. KALETRA is called a protease inhibitor and is used with other anti-HIV-1 medicines to treat people with human immunodeficiency virus (HIV-1) infection. KALETRA is for adults and for children age 14 days and older. KALETRA does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others. People taking KALETRA may still get opportunistic infections or other conditions that happen with HIV-1. Do not take KALETRA if you are allergic to KALETRA or any of its ingredients, including lopinavir or ritonavir. Do not take KALETRA with certain medicines, as they can cause serious problems or death or make KALETRA less effective against HIV. Some patients taking KALETRA can develop pancreas and liver problems, which can cause death. Patients may develop abnormal heart rhythms, large increases in triglycerides and cholesterol, diabetes, high blood sugar and/or changes in body fat. Some patients with hemophilia may have increased bleeding. Click here for Important Safety Information about KALETRA. Resistance in a Clinical Study*† In a clinical study, a group of patients who were new to therapy was treated with KALETRA in their regimen. Another group of patients new to therapy in the same study was treated with an HIV medicine called Viracept® (nelfinavir) in their regimen. Both groups were also given the nucleosides Epivir® (lamivudine) and Zerit® (stavudine). Patients from both groups who had an increase in the amount of HIV in their blood were tested to see if their HIV developed resistance during 24 to 48 weeks of therapy. The results of these tests showed that of the patients who were tested for resistance:
It is important to remember that resistance to KALETRA can occur.
Click here for Important Safety Information about KALETRA. * In the clinical study, 326 patients took KALETRA and 327 patients took Viracept in combination with Epivir and Zerit. After 48 weeks of therapy 67% of patients on the KALETRA regimen vs. 52% of patients on the Viracept regimen achieved an undetectable viral load (less than 50 copies per milliliter of blood). Of the patients taking KALETRA, 58 had detectable viral loads (more than 400 copies per milliliter of blood). Of the patients taking nelfinavir, 102 had detectable viral loads. Patients from both groups were given a blood test to find out if they had detectable viral loads because their HIV developed resistance. Thirty-seven patients taking KALETRA and 76 patients taking Viracept were available for this blood test. † Walmsley S, Bernstein B, King M, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med; 346: 2039-2046. |
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