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How To Cure An Infectious Disease In The World's Poorest Countries

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A picture taken on November 9, 2015 shows Claudia Aulo, a 13-year-old girl living with AIDS who lost both parents to the disease, taking her drugs at her grandmothers house in in Ndiwa. (Photo credit: SIMON MAINA/AFP/Getty Images)

It’s taken many years and tens of billions of dollars, but the number of AIDS-related deaths has almost halved since 2005. But to what degree can the lessons learned from HIV be transferred to a new challenge: preventing deaths from another virus, hepatitis C?

The question matters to me because my employer, Gilead Sciences, is the leading manufacturer of both HIV and hepatitis C (HCV) medicines. HCV therapies remain out of reach for many people living with the disease, and prospects for widespread treatment scale-up seem uncertain at best. To understand why, consider how the landscape has shifted in each of three critical areas: political leadership, donor support and lower drug prices.

In the 2000s, unprecedented global advocacy for HIV treatment led directly to progress on these three key fronts in the 2000s. Since the early 2000s, the Global Fund to Fight AIDS, Tuberculosis and Malaria has committed more than $18 billion to support HIV programs in low- and middle-income countries, and PEPFAR has committed more than $50 billion. Together, they account for the large majority of people on antiretroviral therapy in developing countries today, more than 19.5 million in low- and middle-income countries.

The cost of HIV medicines also fell substantially, as pharmaceutical companies increasingly recognized their obligation to provide access to their medicines to all those in need, and generic companies proved they had the capacity to develop high-quality, low-cost versions of HIV therapies. At Gilead, in low- and middle-income countries, we lowered prices for our branded HIV medicines and also licensed our HIV compounds to multiple generic manufacturers, fostering competition that has lowered the basement cost of tenofovir disoproxil fumarate (marketed by Gilead as Viread®) by 80% since 2006. Today, largely as a result of generic partnerships, Gilead medicines are taken each day by more than 10 million people living with HIV in low- and middle-income countries.

In late 2013, Gilead’s first hepatitis C medicine received U.S. approval, and less than a year later, the drug was launched in Egypt, the country with the world’s highest HCV prevalence. That rapid introduction was made possible by a close partnership between the Egyptian government and Gilead, working together even before U.S. approval to conduct local trials, set up a financing structure and negotiate pricing. Since then, more than a million patients in Egypt alone have been cured of hepatitis C.

But today’s greatest health challenges also compete with other urgent policy crises – terrorism, refugees, climate change – for attention and resources. It is exceedingly difficult for any health condition to rise to the top of the political agenda. We are unlikely to see major new global health funding streams that would allow countries to make large health investments.  Even in nations with a strong commitment to public health, their attention is splintered by numerous priorities. Ebola outbreaks have plagued Western Africa in the last several years, Zika has emerged as a threat in Latin America, antibiotic resistance is on the rise and non-communicable diseases account for a growing share of morbidity and mortality.

We are trying to lower drug prices for these nations. Gilead has modeled its approach in HCV on its successful HIV access program: greatly reduced pricing on branded medicines, tied to a country’s economic status and disease burden, paired with generic licensing to multiple manufacturers. A complete curative HCV regimen in low- and lower-middle-income countries is as low as $750 for branded product and even less for generics, while the mean cost of antiretroviral therapy in PEPFAR-supported programs is approximately $348 per patient per year for a lifetime. But the reality is national health systems are not currently prepared or designed to make upfront investments in new medicines, even if they will yield long-term savings.

Progress is possible. But we can’t recreate the unique HIV treatment access landscape of the 2000s. We need new approaches.

For example, in the country of Georgia, where 7% of adults have HCV, the government is undertaking an ambitious program to eliminate the virus nationwide, employing a combination of disease awareness, screening and treatment initiatives. Georgia’s HCV elimination program started in April 2015 and currently has 30 service centers across the country. Since the end of 2016, 42,000 patients initiated treatment with more than 36,000 completing treatment with cure rates of more than 98% on a Gilead-based regimen.

Although Gilead has donated the treatment for this national scale-up, Georgia and its partners have contributed large investments in the health systems associated with HCV diagnosis and treatment. This underscores the modelling recently done by the World Health Organization and published recently in The Lancet Global Health. The modeling showed that, in 67 low-income and middle-income countries, more than 75% of costs are for health systems with health workforces, with infrastructure as the main cost drivers.

The common thread in all of these efforts is partnership – no single actor can provide access to treatment, so pharmaceutical companies must collaborate with national governments, non-profits and other private sector players in order to reach patients in need.

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