Tag Archives: Sustained Virologic Response

HIV/HCV Co-Infected Patients Show Similar Cure Rates As Monoinfected

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Patients who are co-infected with both HIV and Hepatitis C (HCV) demonstrated similar cure (Sustained Virologic Response – SVR) rates as patients who were monoinfected with HCV, according to research published in Hepatology, a journal published on behalf of The American Association for the Study of Liver Diseases. These findings were gathered using a review of studies dated January 2004 to July 2017, and came to the conclusion that the designation of patients co-infected with HIV/HCV as a “special population” by the U.S. Food & Drug Administration (FDA) should be reconsidered, given the advent and increasing use of Direct Acting Antivirals (DAAs) to treat HCV.

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The special population designation by the FDA is designed to allow physicians and researchers to take into consideration populations who, for a variety of reasons – weight, existing disease morbidity, age, body composition, pregnancy, et cetera – may not respond in a typical fashion to standard treatment regimens. For patients living with HIV, many of the HIV-specific treatment regimens, until the past decade or so, made treating co-morbidities not HIV-related difficult, as other drugs would hamper or have their effects hampered by the medications used to treat patients’ HIV. The advent of newer, more easily tolerated, and more effective HIV medications has allowed for more flexibility.

Thus is the case with HIV/HCV co-infection. Prior to the entry of HCV DAAs to the market in 2013, interferon-based treatments were the only way to actively achieve SVR in HCV-infected patients. Notoriously difficult to tolerate and with a high treatment abandonment rate, interferon-based regimens resulted in very low SVR rates for both mono- and co-infected patients. This, along with the fact that co-infected populations experience accelerated progression of HCV-related liver disease, as well as existing barriers to care, led the FDA to designated HIV/HCV co-infected patients as a specific population with unmet medical needs.

The newer regiments, which are both easier to tolerate and exponentially more effective at achieving SVR, have produced similar SVR rates in both mono- and co-infected populations. This serves as good news to physicians and patients, alike. While these findings are welcome news, physicians must still be certain to determine if HCV regimens will have any counterindications with existing HIV therapies. Current treatment recommendations advise against stopping HIV therapy to pursue HCV treatment.

References:

  • Sikavi, C., Chen, P. H., Lee, A. D., Saab, E. G., Choi, G. & Saab, S. (2017, November 06). Hepatitis C and Human Immunodeficiency Virus Co-Infection in the Era of Direct-Acting Antiviral Agents: No Longer A Difficult to Treat Population. Hepatology. Alexandria, VA: The American Association for the Study of Liver Diseases. Accepted Author Manuscript. doi:10.1002/hep.29642

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Data Analyses Indicate HCV Treatment for All Saves Money; Part 1

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Since the introduction of Sovaldi (Gilead) and Olysio (Janssen) in 2013, Hepatitis C (HCV) advocates have argued several points: (1.) that the price for these drugs was/is too high; (2.) that Medicaid is required to pay for these treatments by law; (3.) that ensuring that HCV-infected patients achieve a Sustained Virologic Response (SVR – “cure”) will reduce the cost of care over time. This last point was the subject of a recent report published in the American Journal of Managed Care (AJMC).

The argument goes like this: HCV is a deadly virus that results in liver cirrhosis, eventual liver failure, and ultimately death; it is also can result in a number of co-morbidities that are costly to treat, including cancer, liver disease, connective tissue disease, abdominal pain, and upper and lower respiratory infections. That said, state Medicaid programs consistently place incredibly stringent Prior Authorization (PA) prerequisites on patients in order for their treatment to be covered, that can include mandatory enrollment in a drug or alcohol recovery program or treatment facility, a mandatory period of abstinence from all drugs or alcohol, failure of other, less easily tolerated treatment regimens, and meeting a certain stage of liver fibrosis (F-Score). These prerequisites are put in place in order to defray the high cost of treatment, ultimately resulting fewer patients being approved and less money being spent.

Advocates and economists, alike, have been arguing for years that the long-term costs associated with leaving HCV patients either untreated, or treated with older Pegylated Interferon-based regimens rather than with newer Direct Acting Agents (DAA) that are more easily tolerated and have a higher SVR rate will ultimately cost Medicaid and other government agencies (as well as private payers) more over time. Medicaid officials from several states have argued that treating every patient on their rosters would not just outstrip their existing pharmacy budgets, but do so four-times over, thus bankrupting the program. Drug manufacturers – Gilead Sciences, in particular – have argued that the cost of one-time treatment for a cure is less expensive than the cost of treating other serious conditions, whose cure rate is far lower, and takes far longer, ranging a period of years, to end in a positive result. The reality is that none of these parties are wrong.

The report in the AJMC, “Treating Medicaid Patients With Hepatitis C: Clinical and Economic Impact,” does an excellent job of outlining all the various consequence related to allowing HCV to go untreated until liver decomposition reaches a certain stage and concludes that adopting a “treat all” strategy will ultimately result in a 39.4% ($3.8 billion) savings and decrease the proportion of total costs attributable to downstream costs of care to 18.3% (Younossi, 2017). It also looks at how Medicaid programs arrived at the current “wait for treatment” model that prevents many patients from being approved for newer DAA regimens.

In next week’s post, HEAL Blog will get into the details of their analysis, their methodology, and their recommendation, as well as look into the feasibility of their proposal – that all state Medicaid programs adopt a “treat all” approach to approving HCV regimens.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

 

 

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