Ugandan Children Are Among the First to Receive Abbott's Lower-Strength Aluvia (lopinavir/ritonavir) Tablet
01/12/2007 11:02
PR Newswire
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.
About KALETRA
Indication and Important Safety Information for lopinavir/ritonavir
Indication
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.
Storage Conditions
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.
About Abbott
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.
Web site: http://www.abbott.com
http://www.KALETRA.com
http://www.abbott.com/HIVAIDS
http://www.abbottglobalcare.org
Jennifer Smoter, +1-847-935-8865, or Dirk van Eeden, +1-847-224-1828, both of Abbott Laboratories