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Generic Antiretrovirals and the Uncertain Future of HIV Care in the United States

Renslow Sherer, MD
[+] Article, Author, and Disclosure Information

From University of Chicago, Chicago, Illinois.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-2981.

Requests for Single Reprints: Renslow Sherer, MD, Section of Infectious Diseases and Global Health, Department of Medicine, University of Chicago, 5841 South Maryland Avenue, MC5065, Chicago, IL 60637.

Ann Intern Med. 2013;158(2):133-134. doi:10.7326/0003-4819-158-2-201301150-00010
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Generic antiretroviral drugs have achieved remarkable results in the global HIV epidemic. In this issue, Walensky and colleagues mathematically model the effect of substituting generic efavirenz and lamivudine in all U.S. persons with HIV who were assumed to receive the branded coformulation of these drugs with tenofovir. The study should serve as a wake-up call to clinicians who care for people with HIV: The era of generic antiretrovirals in the United States has come.

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Generic Antiretrovirals Save Lives, Not Just Money
Posted on January 24, 2013
Jennifer Cohn, MD MPH
Medical Coordinator, Médecins Sans Frontières Access Campaign
Conflict of Interest: None Declared

Sherer argues generic antiretrovirals (ARVs) may result in decreased efficacy for people living with HIV in the US and calls for large-scale clinical trials comparing branded and generic ARVs. This editorial dangerously conflates the efficacy of generic medicines themselves with the effects of patent barriers obstructing the production of ideal generic regimens.

The author’s comments endanger the considerable benefits of generics and risk destroying patient trust in the concept of generics. For example, because of patent barriers, individual components of the fixed-dose combination branded medicine, Atripla, cannot be combined into a single pill. While there is evidence that single-pill combination HIV drugs lead to better treatment outcomes, this is not a problem with the generics themselves, but with the inability to combine quality generic medicines into a single pill. (1, 2)

Generics are the therapeutic equivalent of branded medicine - quality and safety are assured by authorities such as the FDA or WHO. (3, 4) In countries where patents do not block their use, generic versions of Atripla cost between $132 and $207 per person per year, less than 1% of the US price. (5) Requiring clinical trials comparing branded and generic ARVs will put unsustainable financial burden on generic producers and destroy the affordability of generics. Once bioequivalence is shown, these trials are unnecessary. Generics have been critical to providing life-saving ARVs to eight million people globally and many studies have already shown generics to be extremely effective. Confusing the effects of harmful patent barriers with unfounded questions of generic quality is irresponsible and misleading.

1 Bangsberg DR, Ragland K, Monk A, Deeks SG. A single tablet regimen is associated with higher adherence and viral suppression than multiple tablet regi- mens in HIV􏱸 homeless and marginally housed people. AIDS. 2010;24:2835- 40. [PMID: 21045636]

2 Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW, Gross R, et al. Guidelines for improving entry into and retention in care and antiret- roviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel. Ann Intern Med. 2012;156:817-33, W-284-294. [PMID: 22393036]

3 World Health Organization. WHO-health sys- tems and services: prequalification of medicines prequalification programme. http://apps.who.int /prequal/. Accessed April 23, 2010.4 US Food and Drug Administration. President’s emergency plan for AIDS relief: approved and ten- tatively approved antiretrovirals in association with the president’s emergency plan. http://www .fda.gov/InternationalPrograms/FDABeyond OurBordersForeignOffices/AsiaandAfrica/ucm119231 .htm. Accessed April 24, 2010.5 MSF. Untangling the web of antiretroviral prices. 15th Edition – July 2012. Available at http://www.msfaccess.org/content/untangling-web-antiretroviral-price-reductions-15th-edition. Accessed on 22 January, 2013.

Author's Response
Posted on March 13, 2013
Renslow Sherer, MD
University of Chicago
Conflict of Interest: None Declared

In their model of generic antiretrovirals (ARVs) in the United States (US), Walensky et al pragmatically accepted the current realities of patent law in the US, as did I in the accompanying editorial. To do otherwise would have been impractical. Dr. Cohn overlooked the attribution of global decreases in HIV death and incidence rates to generic ARVs in the editorial. I agree with Dr. Cohn that a generic co-formulation of efavirenz, lamivudine, and tenofovir has been shown to be pharmacologically and clinically equivalent to the branded version in other countries, and indeed, it has contributed to these welcome global trends.

In the real world setting of the US with existing patent law, use of generics would require an alternative to one pill once daily. The evidence in support of ‘one pill once daily’ is strong, but not overwhelming. A trial is not needed to establish pharmacologic or generic equivalence, it would be useful to compare the effectiveness of the co-formulated regimen to a deconstructed three pill regimen to convince skeptical US HIV clinicians.

Observational studies may also be useful: At the recent Retrovirus meeting, investigators from Denmark reported an observational study on a national scale in 509 patients who, for economic reasons, were shifted from the more expensive branded co-formulation to its three separate components, two of which are generic. [1] Importantly, only patients on ARVs for more than one year and with no history of compliance problems were selected for this change. In 42.5% of the patients, this was their first regimen. No increase in virologic failures occurred after one year. Clinicians in the US will rightly note the higher standard of living in Denmark, the lack of medication co-pays, and the greater efficiency and national accessibility of the health care system that are in stark contrast to health care in the US. Nonetheless, in this public setting, a multi-pill generic was substituted for a once daily branded co-formulation for cost reasons with no increase in treatment failures after one year.

It is difficult to imagine the implementation of a similarly nuanced public policy in HIV treatment in the US, and even more difficult to imagine its success, given the chaotic care, high co-payments, and frequent swings in Medicaid eligibility and limits in Medicaid coverage that exist in the public sector in the US at present. As a signatory to the Declaration of Human Rights (DHR), the recognized ‘the right of everyone to the enjoyment of the highest attainable standard of physical…health’, and to the DHR affirmation of the right to share equally in the advances of scientific research. [2] At present, the current standard in ARVs is one pill once daily. Dr. Cohn is right to imply that it is our responsibility to remove obstacles to supporting a single standard of HIV care in the United States that includes the use of the best possible ART regimen in the most cost-effective manner possible.

1. Ensig F, Gertstoft J, Helleberg H, Kronborg G, Mathiesen L. VIrological response in patients, who for economic reasons, were changed from atripla to a multi-tablet regimen. IN: Progam and abstracts of the Conference on Retroviruses and Opportunistic Infections, Atlanta, Georgia, March 6, 2013. Poster 579.

2. International Covenant on Economic, Social, and Cultural Rights, January 3, 1976. 25+ Human Rights Documents. Center for the Study of Human Rights, New York, 2005, Page 11.

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