Abbott plans to develop two new formulations of its HIV medicines, Kaletra (lopinavir/ritonavir) and Norvir (ritonavir), to offer new formulation options for people living with HIV-1. The company is currently investigating a new powder formulation of Norvir as well as a co-formulation of three HIV medicines – lopinavir, ritonavir and 3TC (lamivudine).
The Norvir powder formulation is planned to make it easier to store the medicine. The investigational fixed-dose combination of lopinavir, ritonavir and 3TC combines three established HIV medicines and could reduce the daily number of tablets a patient takes. Additionally, this tablet may offer a more cost-effective treatment option for patients. The fixed-dose combination, if developed and approved, would be designed to be taken in combination with one additional anti-HIV medicine.
Abbott is developing the new formulations with the ambition to make a contribution to the World Health Organization’s Treatment 2.0 strategy. This strategy includes providing treatment options to make the most of the resources available in those developing countries that carry the heaviest HIV burden.
“Abbott’s HIV research program confirms our continued commitment to develop and provide effective, quality HIV medicines for patients around the world,” said Scott C. Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. “Advances in HIV treatment formulations are critical as doctors and patients shift their goals from surviving HIV to living with HIV.”
Norvir Powder Formulation
Norvir is most often used in combination with other protease inhibitors as a pharmacokinetic enhancer to increase the blood levels of antiviral medicines that belong to the same group as Norvir (protease inhibitors).The investigational formulation of Norvir is planned to be a heat-stable powder that could be sprinkled over food or added to liquid. This planned formulation could be particularly important for delivering this HIV medicine to developing countries where refrigeration may not be an option. Norvir and another protease inhibitor are given with two additional medications as a daily combination regimen.
“When Abbott originally developed the liquid form of Norvir, we were limited to the technology that was available at the time,” said Brun. “We have developed improved formulation approaches that now allow us to explore a new formulation of Norvir that we hope will be better suited to the needs of HIV-infected children.”
New fixed-dose combination
The investigational fixed-dose combination of Kaletra and 3TC, given with an additional anti-HIV drug, has the potential to offer doctors and patients a simplified medicine that could reduce the number of prescriptions a patient receives and tablets a patient takes.
“Kaletra and 3TC have a long history of use in both the developed and developing worlds,” said Brun. “We are working to ensure that this co-formulation will be heat-stable, which would make it suitable to conditions in areas where storage options are limited.”
Abbott’s Commitment to HIV
Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. The company developed the first HIV diagnostic test more than 25 years ago. Norvir, one of the first protease inhibitors, was launched in 1995 as both a capsule and an oral solution, and remains an essential component of most protease inhibitor-based treatment regimens. And 10 years after its introduction, lopinavir/ritonavir remains a part of the most commonly used second-line treatment regimens in resource limited settings, according to the World Health Organization Price Reporting Mechanism.
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 and a number of nutritionals, devices and diagnostics to help people living with HIV.
Expanding on its scientific contributions, Abbott and the Abbott Fund have invested more than $200 million in developing countries to improve the lives of people affected by HIV/AIDS through programs targeting critical areas of need, including strengthening healthcare systems, supporting children affected by HIV/AIDS and advancing HIV testing and treatment.
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 nearly 90,000 people and markets its products in more than 130 countries.