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

Generic antiretroviral drugs have contributed to re- ity of regimens that contain generic antiretrovirals and de-
markable achievements in the global HIV epidemic.
fining differences in adherence, virologic success, and Mortality has decreased by 24% since 2005, new HIV health care use. How these studies will be supported is infections have decreased by 20% since 2001, and 8 mil- lion persons are receiving treatment (1). In the United Angst and uncertainty about HIV care abound at this States, 10 available generic antiretrovirals have been used time. According to the national version of the “Gardner infrequently because of greater toxicity and inferior effi- Cascade,” fewer than one third of PLWHIV in the United cacy. However, when generic efavirenz becomes available States have sufficient disease control with treatment, and in 2013, a regimen of generic efavirenz and lamivudine fewer than half (36%) are reliably receiving care (11).
with branded tenofovir will become a credible alternative This unacceptably poor performance is worthy of soul- searching. Fortunately, the National AIDS Strategy offers In this issue, Walensky and colleagues (2) mathemat- measured and specific guidance to our response to expand ically model the effect of the substitution of generic efa- HIV testing and improve recruitment and retention in care virenz and lamivudine in all people living with HIV (12, 13). Nonetheless, our HIV care “system” is a fragile (PLWHIV) in the United States who were assumed to edifice with disparate parts. Public sources, such as Medic- receive the branded coformulation of these drugs with aid, Medicare, and the Ryan White Care Act, support 80% tenofovir. They found a 50% reduction in drug costs and a of care for PLWHIV, and the Ryan White Care Act covers savings of $960 million in care costs in 1 year. They also only care, drugs, and services that are not supported by found reduced treatment efficacy, resulting in 4.4 months Medicare and Medicaid. Under the Affordable Care Act of life lost per patient lifetime. Even with substantial vari- (ACA), 32 million uninsured Americans will enter Medic- ations in the model’s assumptions, large-scale cost savings aid starting in 2014, but of 37 states under single-party were achieved, and the comparative cost-effectiveness of control, 24 are hostile to ACA and 20 currently plan not to branded antiretrovirals exceeded the standard threshold of participate in Medicaid expansion (14). Making matters $100 000 per quality-adjusted life-year. Recent studies in worse, rules for ACA that were recently issued left the Europe and the United Kingdom also report substantial definition of “essential health benefits” and drug formulary savings with generic antiretrovirals (3–5).
composition up to states (15). As a result, existing state- Can a regimen of combined generic and branded anti- to-state disparities in HIV care and access to antiretrovirals retrovirals perform as well as a preferred branded 1-pill, once-daily coformulation? Current HIV treatment guide-lines uniformly recommend the use of coformulated anti- In addition to these strains, the Ryan White Care Act, retrovirals because of convenience, superior patient adher- which serves more than 500 000 PLWHIV and provides ence, patient and clinician preference, and lower insurance treatment for 200 000 persons, is up for reauthorization in copayments. Most available evidence support these recom- 2013. High-quality HIV care evolved within the HIV multi- mendations (6). In 1 exception, once-daily regimens of 2 disciplinary team with guidance, training, and funding or 3 equipotent antiretrovirals were not inferior to a from the act. Many care innovations—such as the HIV branded once-daily coformulation (7). Similarly, although medical home and HIV prevention and treatment inte- guidelines recommend once-daily dosing when possible, 1 grated with maternal– child health, mental health, and sub- of 4 “preferred” initial regimens is dosed twice daily, and 7 stance abuse treatment—may be at risk if the act is sub- of 11 studies in a meta-analysis found no difference be- sumed into Medicaid under ACA (16). Community health tween once- and twice-daily regimens (8).
centers are prioritized under ACA, but many lack skills and Would even a small reduction in efficacy be accept- capacity for HIV care and will require training. The act’s able? In the study by Walensky and colleagues, poorer sur- budgets will probably be further strained in states opting vival with generics resulted from minor differences of un- out of Medicaid expansion (17). Because half of its expen- certain clinical significance between lamivudine and ditures are for medications, generic antiretrovirals will be a emtricitabine in resistance outcomes and virologic efficacy critical issue in the reauthorization debate and in state from limited trial data (9, 10). The best regimen choice in Medicaid formulary budgets. Vigilance by HIV advocates their model was generic efavirenz and coformulated emtric- will be critical at the federal and state levels to ensure that itabine plus tenofovir, a 2-pill, once-daily option with sim- the act has sufficient flexibility to improve outcomes in ilar efficacy and lower cost. Large-scale effectiveness trials states that expand Medicaid eligibility to include most that compare generics, including abacavir, with branded PLWHIV and in states that decline Medicaid expansion.
coformulations will be critical in assessing the comparabil- Activism to persuade reluctant states to expand Medicaid 2013 American College of Physicians 133
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Editorial Generic Antiretrovirals and HIV Care in the United States eligibility and to safeguard multidisciplinary HIV care 3. Stoll M, Kollan C, Bergmann F, Bogner J, Faetkenheuer G, Fritzsche C, et
models in the transition into Medicaid will also be crucial.
al; ClinSurv Study Group. Calculation of direct antiretroviral treatment costs
and potential cost savings by using generics in the German HIV ClinSurv cohort.
HIV advocates and caregivers might more readily em- PLoS One. 2011;6:e23946. [PMID: 21931626] brace generic antiretrovirals if, as Walensky and colleagues 4. Gazzard B, Moecklinghoff C, Hill A. New strategies for lowering the costs of
suggest, the savings were diverted to address other funding antiretroviral treatment and care for people with HIV/AIDS in the United King- needs within the field of HIV medicine, but no such mech- dom. Clinicoecon Outcomes Res. 2012;4:193-200. [PMID: 22888265]
5. Sloan CE, Champenois K, Choisy P, Losina E, Walensky RP, Schackman
anism exists. Perhaps a large, simple trial should be con- BR, et al; Cost-Effectiveness of Preventing AIDS Complications (CEPAC)
ducted in which generic and branded antiretrovirals are investigators. Newer drugs and earlier treatment: impact on lifetime cost of care
compared and patients in the generic group are allowed to for HIV-infected adults. AIDS. 2012;26:45-56. [PMID: 22008655] use the cost savings of their regimen to support their an- 6. Llibre JM, Arribas JR, Domingo P, Gatell JM, Lozano F, Santos JR, et al;
Spanish Group for FDAC Evaluation.
Clinical implications of fixed-dose cofor-
nual health insurance premiums, in which case I predict mulations of antiretrovirals on the outcome of HIV-1 therapy. AIDS. 2011;25: rapid accrual. In any case, Walensky and colleagues’ study is a wake-up call to PLWHIV and their clinicians: The era 7. Buscher A, Hartman C, Kallen MA, Giordano TP. Impact of antiretroviral
dosing frequency and pill burden on adherence among newly diagnosed,
of generic antiretrovirals in the United States has come.
antiretroviral-naive HIV patients. Int J STD AIDS. 2012;23:351-5. [PMID: The noted infectious diseases physician John G. Bartlett has predicted that the annual cost of antiretrovirals in 10 8. Parienti JJ, Bangsberg DR, Verdon R, Gardner EM. Better adherence with
years will be less than $200, and he has not often been once-daily antiretroviral regimens: a meta-analysis. Clin Infect Dis. 2009;48:484-8. [PMID: 19140758] wrong when forecasting HIV care trends in the United 9. Svicher V, Alteri C, Artese A, Forbici F, Santoro MM, Schols D, et al.
Different evolution of genotypic resistance profiles to emtricitabine versus lami-vudine in tenofovir-containing regimens. J Acquir Immune Defic Syndr. 2010; 10. Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JM, Miller
MD, et al; 903 Study Group.
Efficacy and safety of tenofovir DF vs stavudine in
combination therapy in antiretroviral-naive patients: a 3-year randomized trial.
JAMA. 2004;292:191-201. [PMID: 15249568] Potential Conflicts of Interest: Disclosures can be viewed at www
11. Centers for Disease Control and Prevention (CDC). Vital signs: HIV pre-ϭM12 vention through care and treatment—United States. MMWR Morb Mortal Wkly Rep. 2011;60:1618-23. [PMID: 22129997]
12. The White House Office of National AIDS Policy. National HIV/AIDS
Strategy for the United States. Washington, DC: The White House Office of
Requests for Single Reprints: Renslow Sherer, MD, Section of Infec-
tious Diseases and Global Health, Department of Medicine, University 13. Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW, Gross
of Chicago, 5841 South Maryland Avenue, MC5065, Chicago, IL R, et al. Guidelines for improving entry into and retention in care and antiret-
roviral adherence for persons with HIV: evidence-based recommendations froman International Association of Physicians in AIDS Care panel. Ann Intern Med.
2012;156:817-33. [PMID: 22393036] Ann Intern Med. 2013;158:133-134.
14. Davey M. One-party control opens states to partisan rush. New York Times.
22 November 2012:A1.
15. U.S. Department of Health and Human Services. Essential Health Benefits,
Actuarial Value, and Accreditation Standards: Ensuring Meaningful, Affordable
Coverage. Washington, DC: U.S. Department of Health and Human Services; 1. Joint United Nations Programme on HIV/AIDS. Global Report: UNAIDS
2012. Accessed at Report on the Global AIDS Epidemic 2012. Geneva: Joint United Nations 16. Martin EG, Schackman BR. What does U.S. health reform mean for HIV clinical care? J Acquir Immune Defic Syndr. 2012;60:72-6. [PMID: 22517415] /20121120_UNAIDS_Global_Report_2012_en.pdf on 12 November 2012.
17. Sherer R. The future of HIV care in the USA. Sex Transm Infect. 2012;88:
2. Walensky RP, Sax PE, Nakamura YM, Weinstein MC, Pei PP, Freedberg
KA, et al. Economic savings versus health losses: the cost-effectiveness of generic
18. Maxmen A. Generic HIV drugs will widen US treatment net. Nature. 2012;
antiretroviral therapy in the United States. Ann Intern Med. 2013;158:84-92.
134 15 January 2013 Annals of Internal Medicine Volume 158 • Number 2
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