KAMPALA, Uganda, December 1 /PRNewswire/ --
- More Than 2 Million Children Living with HIV Stand to Benefit from Scientific Advance
Abbott today made its new lower-strength lopinavir/ritonavir (LPV/r) tablet, known as Aluvia(R) in developing countries and Kaletra(R) in developed countries, available to children living with HIV/AIDS in Uganda -- a step the company hopes will begin to improve the lives of the 2.3 million children worldwide living with HIV/AIDS. The World Health Organization (WHO) recommends LPV/r for the treatment of children who no longer respond to "first line" HIV medicines.
As the first and only co-formulated protease inhibitor tablet that can be used in children, the new lower-strength tablet has the same benefits as the original tablet. The tablet does not require refrigeration and can be taken with or without food - two important advances in delivering HIV medicine in developing countries.
Abbott shipped the medicine to Uganda under a waiver order approved by the country's government. Waiver orders allow medicines to be shipped, before they are approved in a specific country, provided that the national government gives specific permission. However, Abbott accepts waiver orders only after a medicine has been approved by at least one stringent regulator. The Ugandan Government approved the shipment when the U.S. Food and Drug Administration (FDA) approved the lower-strength tablet on Nov. 9. The Ugandan Government's early approval of the waiver order allowed Dr. Victor Musiime of the Joint Clinical Research Centre in Kampala to write the first prescription for the lower-strength tablet just days after it had received marketing authorization in the United States. Other African governments are now also talking to Abbott about the possibility of waiver shipments.
Abbott is also working with African governments to try to expedite registration of this medicine across the continent. Registration in most developing countries can only take place once the regulatory body in the country or region where the medicine is made has approved it, in this case the European Medicines Agency (EMEA).
"Nine out of every ten children with HIV live in sub-Saharan Africa. We developed Aluvia with the distinct needs of children in the developing world in mind," said Mark Masterson, vice president, Asia, Africa, Australia, Central Europe region, Abbott International.
Abbott has invested in sufficient manufacturing capacity to meet the anticipated global demand for the Aluvia tablets and plans to register the lower-strength Aluvia tablet in 150 countries - broader registration than any other pediatric HIV medicine. The company will supply the lower-strength tablet at half the price of the original tablet in developing countries. Both the original strength and lower-strength versions of Abbott's Aluvia tablets are more affordable in these 69 countries than any generic copy.
"Introduction of second-line medicine for children living with HIV will help restore hope for millions of parents and children who would otherwise face a bleak future if first-line therapy failed," said Dr. Peter Mugyenyi, chair and director, Joint Clinical Research Centre (Uganda's pioneer AIDS research and treatment institution), and chairman of African Dialogue on AIDS. "Co-formulated lopinavir/ritonavir is a WHO-recommended second-line HIV treatment regimen for children, and Abbott is making its latest, most innovative version available to our most vulnerable sector of society: children who live in poor countries."
Abbott's effort to provide African children with HIV treatments is part of its five-point global strategy to expand access to HIV treatments around the world by:
-- Focusing on pediatric HIV care -- Continuing to innovate with an eye on the needs of the developing world -- Investing in manufacturing capacity to ensure consistent, quality supply -- Offering tiered and affordable pricing -- Broadening registration of life-enhancing medicines
About Abbott's FDA-Approved Lower-Strength Aluvia Tablet
Abbott's new Aluvia tablet is a lower-strength LPV/r formulation intended to prevent HIV from spreading within the immune system. It is the first and only co-formulated protease inhibitor tablet that can be used in children and is suitable for pediatric patients who meet weight and age requirements for dosing and are reliably able to swallow the tablet intact.
Developed using breakthrough melt-extrusion technology (Meltrex(TM)), the new lower-strength tablet formulation offers the same benefits as the original full-strength tablet but contains 100 mg of lopinavir and 25 mg of ritonavir, as compared to the 200 mg lopinavir and 50 mg ritonavir in the original tablet.
About Abbott's Commitment to Fighting HIV/AIDS
HIV/AIDS is a global problem that demands shared commitment and shared responsibility. Abbott is committed to working with governments, multilateral organizations, nongovernmental organizations (NGOs) and civil society to expand access to HIV/AIDS treatments around the world.
Through its Access program, Abbott provides its HIV medicines at no-profit pricing in many developing countries. Since April 2007, Abbott has offered its HIV medicines in two pricing tiers across 115 low- and lower-middle-income countries. In addition, Abbott has consistently made its medicines available at a price below that of any generic competitor in each of the pricing tiers.
Abbott and Abbott Fund are investing more than US$100 million in developing countries through the Abbott Global AIDS Care programs focusing on four areas: strengthening health care systems; helping children affected by HIV/AIDS; preventing mother-to-child transmission of HIV; and expanding access to testing and treatment.
According to the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the WHO, in 2006, an estimated 2.3 million children under the age of 15 were living with HIV/AIDS worldwide. Last year alone, an estimated 530,000 children were infected with HIV, and 380,000 children died of AIDS. The WHO recommends lopinavir/ritonavir as one of three protease inhibitor (PI) options for the treatment of children who no longer respond to first-line HIV medicines. The U.S. Department of Health and Human Services recommends lopinavir/ritonavir for the initial treatment of children with HIV.
For more information about Abbott's commitment to fighting HIV/AIDS, please visit our Web site at http://www.abbott.com/hiv.
Indication and Important Safety Information for lopinavir/ritonavir
Kaletra is indicated for the treatment of HIV-1 infected adults and children above the age of two years. It is used in combination with other antiretroviral agents.
Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.
Kaletra Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information visit http://www.KALETRA.com.
Kaletra should not be taken by patients who have had an allergic reaction to any of its ingredients, including lopinavir or ritonavir, or any of the excipients, or by patients with severe liver problems.
Taking certain medications with Kaletra could cause serious side effects that could be life threatening. Do not take Kaletra with astemizole, terfenadine, midazolam, triazolam, pimozide, cisapride, ergotamine, dihydroergotamine, ergonovine, and methylergonovine, rifampicin, amiodarone, vardenafil and products containing St. John's Wort (Hypericum perforatum).
Medical advice and approval must be sought before Kaletra is taken with medicines that lower blood cholesterol (e.g. lovastatinor simvastatin), some medicines affecting the immune system (e.g., cyclosporin, sirolimus (rapamycin), tacrolimus), various steroids (e.g., dexamethasone, fluticasone propionate, ethinyl oestradiol), other protease inhibitors, certain heart medicines such as calcium channel antagonists, (e.g., felodipine, nifedipine, nicardipine) and medicines used to correct heart rhythm (e.g., bepridil, systemic lidocaine, quinidine), antifungals, (e.g., ketoconazole, itraconazole), morphine-like medicines (e.g., methadone) anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital), warfarin, certain antibiotics (i.e., rifabutin, clarithromycin), certain antidepressants (e.g. trazodone) and voriconazole.
Kaletra may interact with erectile dysfunction agents (e.g., sildenafil or tadalafil). Lower doses of these medicines should be prescribed in patients taking Kaletra. Kaletra may interact with digoxin (heart medicine); monitoring by a physician is recommended.
Taking Kaletra with certain medicines can cause increased levels of these other medicines in the body. This could increase or prolong their effects and/or adverse reactions, which may result in serious or life-threatening problems. Because of this, patients must tell their doctor about all medicines they are taking or planning to take, including those medicines that can be bought without a prescription and herbal preparations.
Patients using an oral contraceptive or using a patch contraceptive to prevent pregnancy should use an additional or alternative type of contraception since Kaletra may reduce the effectiveness of these products.
Pregnant or nursing mothers should not take Kaletra unless specifically directed by their doctor.
Kaletra oral solution contains 42 percent alcohol. While taking Kaletra oral solution, patients should not take any medicines that may cause a reaction with alcohol such as disulfiram.
It is important that Kaletra oral solution is taken with food. Kaletra tablets may be taken with or without food. It is important that Kaletra tablets are swallowed whole and not be chewed, broken or crushed.
Cases of pancreatitis have been reported in patients taking Kaletra. Liver problems, which can be fatal, have also been reported. Patients should tell their doctor if they have had liver disease such as chronic hepatitis B or C as they are at increased risk for severe and potentially fatal liver adverse events. These patients may require blood tests for control of liver function.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Patients should contact their doctor if they notice changes in body fat.
In patients taking protease inhibitors, increased bleeding (in patients with hemophilia type A and B) has been reported.
Combination antiretroviral therapy may cause new cases of diabetes and high blood sugar or worsening of existing diabetes, as well as increased fats and raised lactic acid in the blood. The long-term risks for complications due to increases in triglycerides and cholesterol are not known at this time. In addition, large amounts of triglycerides have been considered a risk factor for pancreatitis.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. Symptoms of infection should be reported to a doctor immediately.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis. Signs and symptoms are joint stiffness, aches and pains (especially in the hip, knee and shoulder) and difficulty in movement. These symptoms require that patients contact their doctor.
In lopinavir/ritonavir adult clinical trials, the very commonly reported (>1 out of 10 persons treated) and commonly reported (less than 1 out of 10 but more than 1 out of 100 persons treated) side effects of moderate to severe intensity were diarrhea, insomnia, headache, nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder, rash, lipodystrophy, weakness and abnormal liver enzymes. This is not a complete list of reported side effects.
In children two years of age and older, the safety profile is similar to that seen in adults.
For more information about Kaletra, please consult your local prescribing information.
Kaletra tablets do not require any special storage conditions.
Kaletra oral solution: Store in a refrigerator (2-8 degrees C). If kept outside of the refrigerator, do not store above 25 degrees C and discard any unused contents after 42 days (6 weeks). Avoid exposure to excessive heat.
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.
Abbott 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 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com. For more information on Abbott's HIV/AIDS programs, please visit http://www.abbott.com/HIVAIDS and http://www.abbottglobalcare.org.
Jennifer Smoter, +1-847-935-8865, or Dirk van Eeden, +1-847-224-1828, both of Abbott Laboratories