Abbott announced that the new tablet formulation of its protease inhibitor Aluvia (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 per cent 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 antiretroviral agents.
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: 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; and Focusing on paediatric HIV care.
"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, MD., 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) and as an oral solution since it was first approved in the United States in September 2000. Using its breakthrough Meltrex 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 US Food and Drug Administration in 2005 and the European Medicines Agency in 2006.