December 2, 2015
Few advances in HIV medicine since the advent of combination antiretroviral therapy (ART) can compete in significance with the new highly effective and tolerable cures for hepatitis C (HCV) infection. With up to a third of people living with HIV also chronically infected with HCV, and coinfection associated with significantly reduced life expectancy, what is good for HCV is good for HIV.
While initial studies suggested similar response rates to direct-acting antiviral agent (DAA) HCV therapy for both coinfected patients and those with HCV alone, this year we saw several treatment studies that looked specifically at those harboring both viruses. Major treatment studies of HIV/HCV-coinfected patients are shown in the table below.
Overall, the super-high SVR (sustained virologic response) rates seen in these studies confirm that HIV infection is not a strike against achieving cure of HCV with DAAs. But, being HIV positive does nothing to protect the patient from the morass that is the HCV drug procurement process.
The high wholesale list prices of HCV regimens have led to shortsighted responses from private and public insurers that have made life difficult for people with HCV infection and their providers. Medicaid, which gets a deep discount on the cost of these drugs, in particular has been a bear to work with. Each state Medicaid program has its own criteria for approval and listed regimens for use -- the former typically ignorant of clinical science and the latter predicated on the best deal that could be cut with a pharmaceutical company. One study from Lo Re and colleagues presented at the American Association for the Study of Liver Diseases (AASLD) meeting this year reported that almost half of the prescriptions for HCV therapy for Medicaid patients handled by two large mid-Atlantic specialty pharmacies were denied last year.
Compounding the bureaucratic obstacles to HCV treatment access is a paucity of providers of HCV care, especially for those who are uninsured or underinsured. While there have been calls for increased HCV screening, there has been less emphasis on building the actual capacity to get care to those who test positive. Gastroenterologists who treat HCV are overrun and cannot handle the load alone. Some infectious diseases specialists are treating HCV (as they should), but there is little incentive for them or primary care providers to take on HCV care given the frustrating and tortured process to obtain HCV medications.
As studies demonstrating the personal and societal value of treatment of HCV accumulate and the cost of HCV therapy drops, this bizarre landscape of great new medications variably out of reach for many who need them will evolve from its current primitive state. Until then, we risk more new cases of HCV among the growing numbers turning to injection drug use, and disease progression for those with chronic HCV for whom a cure seems so close, but sadly remains so far.
What are some other top clinical developments of 2015? Read more of Dr. Wohl's picks.
David Alain Wohl, M.D., is an associate professor of medicine in the Division of Infectious Diseases at the University of North Carolina and site leader of the University of North Carolina AIDS Clinical Trials Unit at Chapel Hill.
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