Johannesburg, South Africa (ots/PRNewswire) -
- More than 5 Million South Africans Living with HIV Gain Access
to First and Only Co-formulated, Non-refrigerated Protease Inhibitor
Abbott (NYSE: ABT) today announced that the new tablet
formulation of its protease inhibitor Aluvia(R)
(lopinavir/ritonavir), for the treatment of HIV-1, is now available
to HIV/AIDS patients in South Africa -- a step the company hopes will
positively impact millions of lives across the country.
"Today marks a new beginning for the treatment of HIV in South
Africa," said Steven Miller, professor, Innovir Institute,
Johannesburg, South Africa. "Millions of patients will now have the
opportunity to benefit from a highly effective, co-formulated
protease inhibitor that does not require refrigeration -- a critical
step in advancing treatment and care in a country where HIV
prevalence is among the highest in the world."
South Africa has experienced one of the most severe HIV/AIDS
epidemics in the world. The Actuarial Society of South Africa
estimates that, in 2006, almost half of all deaths in the country
were caused by AIDS. Among adults aged 15-49 years, 71 percent of
deaths were AIDS-related.
The lopinavir/ritonavir tablet (marketed as Aluvia in the
developing world) 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 advances in delivering HIV
medicine, especially in developing countries. The tablet formulation
also offers the increased dosing convenience of fewer pills (a total
daily dose of four tablets, instead of six soft-gel capsules). Each
Aluvia tablet contains 200 mg of lopinavir and 50 mg of ritonavir.
The World Health Organization (WHO) has identified
lopinavir/ritonavir as the recommended protease inhibitor for
second-line therapy in resource-restricted countries, such as South
Africa. Aluvia is always used in combination with other
Abbott's introduction of the Aluvia tablet in South Africa is
part of its five-point global strategy to expand access to HIV
treatments around the world by:
@@start.t1@@ -- Continuing to innovate with an eye on the needs of the developing
-- Investing in manufacturing capacity to ensure consistent, quality
-- Offering tiered and affordable pricing;
-- Broadening registration of life-enhancing medicines; and
-- Focusing on pediatric HIV care.@@end@@
"Bringing a heat-stable tablet version of lopinavir/ritonavir to
South Africa is another example of Abbott's commitment to working
with the business community and health community to improve health
systems and address challenges of capacity building and access in
Africa and beyond," said Scott Brun, M.D., divisional vice president,
infectious diseases and immunology development, Global Pharmaceutical
Research and Development, Abbott.
Lopinavir/ritonavir has been available in soft-gel capsules
(known as Kaletra(R)) and as an oral solution since it was first
approved in the United States in September 2000. Using its
breakthrough Meltrex(TM) technology, Abbott developed the tablet
formulation, which maintains a similar safety and efficacy profile as
the soft-gel capsule. The tablet formulation received approval from
the U.S. Food and Drug Administration in 2005 and the European
Medicines Agency in 2006.
Progress on Global Registration of Lopinavir/Ritonavir Tablets
Abbott has worked diligently to register the tablet around the
world. Today, the tablet is filed, available (where no regulatory
approval is needed) or approved in 154 countries. The original
lopinavir/ritonavir capsule is registered in 118 countries, making it
the most widely registered HIV medicine in the world (according to
The lopinavir/ritonavir tablet is now filed, available or
approved in nearly every African country (48 countries), where the
majority of the world's people with HIV live. In addition to South
Africa, the tablet is available or approved in: Angola, Benin,
Botswana, Cameroon, Camoros, Central African Republic, Congo
Brazzaville, Cote d'Ivoire, Djibouti, DR Congo, Ethiopia, Gabon,
Ghana, Guinea Conarkry, Kenya, Lesotho, Libya, Malawi, Mauritius,
Mauritania, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone,
Swaziland, Tanzania, Togo, Uganda and Zambia.
Availability of Lower-Strength Lopinavir/Ritonavir Tablets
Abbott also has filed its lower-strength lopinavir/ritonavir
tablet, suitable for pediatric use, in South Africa. This new
formulation represents a significant advancement for clinicians and
patients in developing countries, where more than 2 million of the
estimated 2.5 million children with HIV/AIDS under 15 years of age,
worldwide, lived in 2007. The lower-strength tablet formulation
contains 100 mg of lopinavir and 25 mg of ritonavir. The
lower-strength tablet is filed, available or approved in more than
80 countries around the world. Abbott intends to make the
lower-strength tablet available or approved in 155 countries around
the world, just as it will with the adult 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 and patient groups to expand access to HIV treatments
around the world. Abbott has also made significant investments in
expanding manufacturing capacity to meet the growing demand for HIV
treatment in developing countries.
Abbott's lopinavir/ritonavir formulations are among the
lowest-priced protease inhibitors in the developing world. Abbott has
been providing its HIV medicines at a price of US$500 per adult
patient per year in all African and least developed countries since
2002, making these medicines more affordable than any generic copies.
Abbott and the company's philanthropic foundation, Abbott Fund,
have invested more than US$100 million in the fight against HIV/AIDS
in Africa and the developing world. Abbott Fund-supported programs
have served more than 700,000 children and families. In addition,
more than 250,000 patients have been tested through Abbott
Fund-supported voluntary counseling and testing programs, with
thousands being referred to treatment programs. Abbott also has
donated more than 8 million rapid HIV tests to help prevent
mother-to- child HIV transmission.
Abbott and Abbott Fund have announced several efforts to expand
access to treatment and care for children living with HIV/AIDS,
including an additional investment of US$12 million in grants and
product donations this year.
For more information about Abbott's commitment to fighting
HIV/AIDS, please visit http://www.abbott.com/hiv.
Indication and Important Safety Information for
Aluvia is indicated for the treatment of HIV-1 infected adults
and children above the age of 2 years. It is used in combination with
other antiretroviral agents.
Aluvia does not cure HIV infection or AIDS and does not reduce
the risk of passing HIV to others.
Important Safety Information
Aluvia 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 Aluvia could cause serious side
effects that could be life threatening. Do not take Aluvia with
astemizole, terfenadine, midazolam, triazolam, pimozide, cisapride,
ergotamine, dihydroergotamine, ergonovine, methylergonovine,
rifampicin, amiodarone, vardenafil and products containing St. John's
Wort (Hypericum perforatum).
Medical advice and approval must be sought before Aluvia is taken
with medicines that lower blood cholesterol (e.g., lovastatin or
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 (e.g., rifabutin, clarithromycin),
certain antidepressants (e.g., trazodone) and voriconazole.
Aluvia may interact with erectile dysfunction agents (e.g.,
sildenafil or tadalafil). Lower doses of these medicines should be
prescribed in patients taking Aluvia.
Aluvia may interact with digoxin (heart medicine); monitoring by
a physician is recommended.
Taking Aluvia 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 Aluvia may reduce the
effectiveness of these products.
Pregnant or nursing mothers should not take Aluvia unless
specifically directed by their doctor.
Aluvia tablets may be taken with or without food.
Cases of pancreatitis have been reported in patients taking
lopinavir/ritonavir. 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
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
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 common and
commonly reported 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 2 years of age and older, the safety profile is
similar to that seen in adults.
For more information about Aluvia, please consult your local
JOHANNESBURG, South Africa, June 3 /PRNewswire/ --
Aluvia tablets do not require any special storage conditions.
Abbott and HIV/AIDS
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
About Abbott Fund
Abbott Fund is a philanthropic foundation established by Abbott
in 1951. Abbott Fund's mission is to create healthier global
communities by investing in creative ideas that promote science,
expand health care and strengthen communities worldwide.
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 more than 68,000 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
ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.ch
Dirk van Eeden, +1-847-224-1828, or Susan Beverly, +1-847-935-9096,
both of Abbott