Increasing access to treatment for CMV retinitis in HIV-patients, a major cause of blindness in developing countries
Agreement with Medicines Patent Pool, an UN-backed organization, improves access to a key medicine to treat cytomegalovirus (CMV) retinitis in people living with HIV in developing countries. CMV retinitis is caused by a viral infection that can result in loss of vision if not treated appropriately. The supply agreement substantially improves access to Valcyte (valganciclovir), an easy-to-take oral medicine, by making it up to 90% cheaper in 138 developing and emerging countries.
Cytomegalovirus retinitis (CMVR) is a treatable disease caused by cytomegalovirus (CMV). The virus attacks the retina of the eye in patients with suppressed immune systems, specifically those infected with HIV, and can cause irreversible blindness.
Vision loss from CMVR can be prevented through early diagnosis and treatment of the virus infection. In developed countries, HIV disease is most often well controlled and opportunistic infections such as CMVR are thus reduced and can be treated if they occur. The full scale of the CMVR problem in developing regions is still not known, as most cases of CMV retinitis are never diagnosed. It has been estimated that between 5% to 30% of all people living with HIV in developing countries can be expected to develop this blinding disorder at some point during the course of their illness, and that CMVR claims the sight of thousands of people each year1.
At-risk people living in developing countries, especially in Asia, and to a lesser extent in Latin America and Africa, are the most vulnerable to CMVR. Lack of training in diagnostic techniques, poor access to treatment options and people presenting in late stage disease are some of the biggest roadblocks to preventing and treating CMVR in these countries.
Currently, the most widely used treatment for CMVR in developing countries consists of intraocular (injections to the eye) or intravenous injections with the drug ganciclovir. Current guidelines for the treatment of CMVR strongly recommend oral valganciclovir and IV ganciclovir as the preferred systemic therapy2. Intravenous injections present logistical challenges, requiring hospitalisation of patients and care by highly trained staff. Valganciclovir, which is an oral version, helps overcome several of these hurdles. In many of these developing countries, however, the absence of quality-assured sources of affordable valganciclovir contributes to the lack of screening, diagnosis and treatment.
What we're doing
Valcyte is Roche’s branded valganciclovir3. Until recently, however, the drug was often not available or affordable for patients in low-income countries.
To increase the number of people able to access and benefit from Valcyte, we entered into a supply agreement with the Medicines Patent Pool in August 2013. The agreement effectively reduces the price of Valcyte by up to 90% in developing countries.
The Medicines Patent Pool, a United Nations backed non-profit organisation, aims to improve the health of people in low- and middle-income countries by creating a pool of relevant patents for licensing to generic manufacturers and other producers. However, in order to speed availability of quality valganciclovir, the Medicines Patent Pool and Roche agreed to cooperate under a type of supply agreement.
The agreement enables eligible non-profit organisations and non-profit treatment programmes, such as national HIV treatment programmes, to purchase reliable, quality valganciclovir at a price close to the cost of manufacture. Agencies include the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), the United States Presidents Emergency Plan for AIDS Relief (PEPFAR), UNITAID, UNICEF and Médecins Sans Frontières (MSF).
“The agreement between the MPP and Roche makes an oral treatment for CMV available to programmes and their patients at lower prices, to help break a cycle of lack of screening and treatment in many developing countries,” said Greg Perry, Executive Director of the Medicines Patent Pool.
“Roche is committed to making Valcyte available to patients suffering from HIV-related CMV infections in developing countries. Our aim is to provide access to affordable Valcyte that is produced under quality conditions and increase the number of people who can access and benefit from our products,” said Daniel O’Day, COO of Roche Pharma.
Under the agreement, Valcyte is now available at close to non-profit prices for HIV/AIDS programmes in 138 countries, including India and China. To date, deliveries have been made to Honduras, Laos, Malawi, Myanmar, Nicaragua, Algeria, Cap Verde, Mozambique and the Philippines.
1.Ford N, Shubber Z, Saranchuk P, Pathai S, Durier N, O’Brien DP, et al. Burden of HIV-related cytomegalovirus retinitis in resource-limited settings: a systematic review. Clin Infect Dis Off Publ Infect Dis Soc Am. 2013 Nov;57(9):1351–61.
2.Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. http://aidsinfo.nih.gov/ContentFiles/Adultand AdolescentGL.pdf. 2013
3.Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)