Abbott's PROGRESS Study of Kaletra and Isentress Compared with a Standard HIV Regimen Meets the Pre-Specified Primary Efficacy Endpoint - Abbott Press Release
* PROGRESS is the First Study to Present 48-Week Efficacy Results for this Combination When Used in Treatment-Naïve Patients with HIV
July 19, 2010
Vienna, Austria - Abbott (NYSE: ABT) today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naïve adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study. These data met the primary efficacy endpoint, which measured whether a similar proportion of treatment-naïve HIV-infected patients reached undetectable viral loads. The results were presented at the 28th International AIDS Conference in Vienna, Austria.
"The 48-week PROGRESS study results, while not definitive, suggest that the nucleoside-sparing HIV regimen of Kaletra and Isentress may be an alternative treatment option for patients new to HIV therapy, when compared to a standard HIV regimen. This further advances our research into new HIV treatment classes and explores the use of alternative drug combinations for patients," said Jacques Reynes, M.D., professor of medicine, head of the Infectious and Tropical Disease Department at the University Hospital Center of Montpellier, France, and a presenting author of the PROGRESS study.
HIV treatment regimens are typically drawn from approximately 20 approved antiretroviral medications in six classes. Standard regimens for treatment-naïve patients generally consist of two NRTIs plus either a PI or a non-nucleoside reverse transcriptase inhibitor (NNRTI).
PROGRESS is a global, multicenter, 96-week open-label study of approximately 200 HIV-infected patients. Physicians should use caution when interpreting these results of the PROGRESS study. Key findings through week 48 include:
* A similar proportion of patients had HIV-1 RNA levels less than 40 copies/mL (defined as undetectable) when treated with Kaletra and Isentress, compared to Kaletra and Truvada.
* Both groups, on average, had a similar positive immune response, measured by their increase in CD4+ T-cell counts.
* The safety and tolerability, including incidences of treatment-emergent moderate-to-severe medication-related adverse events, were generally similar between regimens. Lipid (cholesterol and triglyceride) elevations were observed more frequently in the Kaletra and Isentress group.
"Kaletra is one of the most widely-studied protease inhibitors available, and Abbott believes it is important to look at new ways of combining Kaletra with other HIV medications to explore additional treatment options for patients," said Scott C. Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "The PROGRESS study is another step toward understanding the science behind potential new treatment approaches to help people living with HIV and demonstrates Abbott's continued commitment to HIV research."
About the PROGRESS Study
* PROGRESS is an open-label, 96-week study evaluating the efficacy and safety of Kaletra in combination with Isentress, compared to Kaletra and Truvada in antiretroviral-naïve patients.
* Merck supplied Isentress for the PROGRESS study.
More Information on Kaletra
Kaletra® (lopinavir/ritonavir) is a prescription anti-HIV-1 medicine called a protease inhibitor that contains lopinavir and ritonavir. Kaletra is used with other anti-HIV-1 medicines to increase the chance of treatment response in people with human immunodeficiency virus (HIV-1) infection. It is not known if Kaletra is safe and effective in children under 14 days old.
Kaletra does not cure HIV-1 infection or AIDS and does not stop people from 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 any of its ingredients, including lopinavir or ritonavir. Do not take Kaletra with certain medicines, as they can cause serious problems, death, or make Kaletra less effective against HIV. Some patients taking Kaletra can develop inflammation of the pancreas and liver problems, which can cause death. Patients may develop changes in heart rhythm, large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or increased bleeding in people with hemophilia. Some patients may develop signs and symptoms of serious infections they already have after starting anti-HIV medicines. Please see the Important Safety Information for more details.
Please click here for full Prescribing Information, including Medication Guide for Kaletra.
Globally, Prescribing Information varies. For more information about Kaletra, please consult full Prescribing Information.
* The Kaletra tablet is the first and only co-formulated protease inhibitor tablet that does not require refrigeration and can be taken with or without food, two important factors in delivering HIV medicine, especially in developing countries.
* The Kaletra tablet is approved in the United States for two dosing options in appropriate adult patients who are new to treatment or who have previously taken antiretroviral therapy, which can provide additional dosing flexibility for patients.
* This year marks the 10th anniversary of the U.S. Food and Drug Administration's (FDA) approval of Kaletra for the treatment of HIV. The FDA granted early access approval on Sept.15, 2000. Kaletra and other protease inhibitors have become critical components of HIV combination therapy used to help patients manage HIV today. Many innovations in HIV treatment have occurred during the past decade, giving physicians and patients more treatment options.
More Information on Isentress
* Isentress is the first medicine to be approved in a new class of antiretroviral medications called integrase inhibitors.
* Isentress is approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients new to treatment and adult patients who have previously taken antiretroviral therapy. The safety and efficacy of Isentress have not been established in pediatric patients.
* Isentress works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.
Important Safety Information for Kaletra
Kaletra should not be taken by people who are allergic to Kaletra or any of its ingredients, including lopinavir or ritonavir. Skin rashes, some of them severe, can occur in people who take Kaletra. People should tell their doctor if they had a rash when they took another medicine for HIV or if they notice any skin rash when they take Kaletra.
The list of drug interactions below is not complete. People must tell their doctor about all medicines they are taking or planning to take, including those without a prescription, vitamins, and herbal products.
Serious problems or death can happen taking these medicines with Kaletra: ergot-containing medicines, including ergotamine (Cafergot® and others), dihydroergotamine (D.H.E. 45® and others), ergonovine (Ergotrate®), and methylergonovine (Methergine®); triazolam (Halcion®); midazolam oral syrup; pimozide (Orap®); lovastatin (Mevacor®); simvastatin (Zocor®); rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®); sildenafil (Revatio®) only when used to treat pulmonary arterial hypertension; alfuzosin (Uroxatral®); or products containing St. John's wort (Hypericum perforatum).
The following medicines may need changes when taken with Kaletra: birth control pills that contain estrogen ("the pill"), birth control (contraceptive) patches, nilotinib (Tasigna®), dasatinib (Sprycel®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®), fosamprenavir (Lexiva®), nelfinavir (Viracept®), phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, sildenafil (Viagra®), tadalafil (Cialis®, Adcirca®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with fluticasone propionate (Advair®), colchicine (Colcrys®), bosentan (Tracleer®), fentanyl (Duragesic®, IonsysTM, Fentora®) and methadone.
Kaletra should not be administered once daily in combination with carbamazepine (Tegretol® and Epitol®), phenobarbital (Luminal®), or phenytoin (Dilantin®).
There is an increased risk of certain problems when taking medicines used for the treatment of erectile problems such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) with Kaletra, because the interaction with these medicines may result in an increase in their side effects, such as low blood pressure (dizziness or fainting), vision changes, and/or erections lasting more than 4 hours. People should tell their doctor right away if they experience any of these side effects.
Kaletra oral solution contains a large amount of alcohol. People should talk with their doctor if they take or plan to take metronidazole (Flagyl®) or disulfiram (Antabuse®). They can have severe nausea and vomiting if they take these medicines with Kaletra.
Kaletra can cause serious side effects:
Kaletra may not be right for everyone. People should tell their doctor about all their medical conditions.
Changes in heart rhythm and electrical activity of the heart can occur when taking Kaletra. These changes can lead to serious heart problems. The risk for these problems may be higher for people who already have a history of abnormal heart rhythm or other types of heart disease, or if they take other medicines that can affect their heart rhythm while taking Kaletra. People should tell their doctor right away if they experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats.
Liver problems, including death, can happen in people who take Kaletra. Blood tests in people who take Kaletra may show possible liver problems. People with liver disease such as hepatitis B or C who take Kaletra may have worsening liver disease. People should tell their doctor right away if they have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain.
Inflammation of the pancreas (pancreatitis), which may be serious and cause death, has occurred in some people who take Kaletra. People have a higher chance of having pancreatitis if they have had it before. People should tell their doctor if they have nausea, vomiting, and/or abdominal pain, as these may be signs of pancreatitis.
Immune reconstitution syndrome may occur after starting anti-HIV medicines, including Kaletra. This happens when people develop signs and symptoms of serious infections they already have, which may require additional treatment.
Large increases in certain fat (triglycerides and cholesterol) levels in the blood have occurred in some people receiving Kaletra. The long-term chance of getting complications such as heart attacks or strokes due to these increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time.
New or more serious diabetes and high blood sugar (hyperglycemia) have occurred in some people who take protease inhibitors, including Kaletra. People should tell their doctor if they notice an increase in thirst or urinate often while taking Kaletra.
Changes in body fat have been seen in some people who take anti-HIV therapy. The cause and long-term health effects of these conditions are not known at this time.
Increased bleeding has occurred in some people with hemophilia who take protease inhibitors, including Kaletra.
Women taking birth control pills or using patches to prevent pregnancy should use an extra form or a different type of birth control since birth control pills or patches may not work as well while taking Kaletra. Women should talk to their doctor about how to prevent pregnancy while taking Kaletra.
It is not known if Kaletra will harm unborn babies. Women who are pregnant or planning to become pregnant should tell their doctor.
Women taking Kaletra during pregnancy should talk with their doctor about how they can take part in an Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to follow the health of the mother and their baby.
Women should not breast-feed while taking Kaletra. There is a chance that HIV can be passed to the baby through breast milk and their baby may have serious side effects from Kaletra.
Common side effects of Kaletra include diarrhea, nausea, stomach area (abdominal) pain, feeling weak, vomiting, headache, and upset stomach. These are not all of the possible side effects of Kaletra.
The long-term effects of Kaletra are not known at this time.
Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. Abbott has developed two protease inhibitors for the treatment of HIV.
Expanding on its scientific contributions, Abbott and the Abbott Fund have invested more than $100 million in developing countries to improve the lives of people affected by HIV/AIDS through programs targeting critical areas of need, including strengthening health care systems, supporting children affected by HIV/AIDS, and advancing HIV testing and treatment. For more information on Abbott's HIV/AIDS programs, please visit www.abbott.com/HIVAIDS and www.abbottglobalcare.org.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.
Truvada is a registered trademark of Gilead Sciences.