Ronald O. Valdiserri

A Way Forward: The National Hiv/aids Strategy and Reducing Hiv Incidence in the United States

In July 2010, the Obama Administration released a National HIV/AIDS Strategy for the United States to refocus national attention on responding to the domestic HIV epidemic. The goals of the strategy are to reduce HIV incidence; to increase access to care and optimize health outcomes among people living with HIV; and to reduce HIV-related disparities. The strategy identifies a small number of action steps that will align efforts across federal, state, local, and tribal levels of government, and maximally impact the domestic HIV epidemic. In this article, we outline key programmatic and research issues that must be addressed to accomplish the prevention goals of the National HIV/AIDS Strategy.

Confronting the emerging epidemic of HCV infection among young injection drug users

Hepatitis C virus infection is a significant public health problem in the United States and an important cause of morbidity and mortality. Recent reports document HCV infection increases among young injection drug users in several US regions, associated with Americas prescription opioid abuse epidemic. Incident HCV infection increases among young injectors who have recently transitioned from oral opioid abuse present an important public health challenge requiring a comprehensive, community-based response. We summarize recommendations from a 2013 Office of HIV/AIDS and Infectious Disease Policy convening of experts in epidemiology, behavioral science, drug prevention and treatment, and other research; community service providers; and federal, state, and local government representatives. Their observations highlight gaps in our surveillance, program, and research portfolios and advocate a syndemic approach to this emerging public health problem.

Measuring what matters: development of standard HIV core indicators across the U.S. Department of Health and Human Services.

Address correspondence to: Ronald O. Valdiserri, MD, MPH, U.S. Department of Health and Human Services, Office of HIV/AIDS and Infectious Disease, 200 Independence Ave. SW, HHH Building, Room 443-H, Washington, DC 20201; tel. 202-690-5560; fax 202-690-7560; e-mail . Ronald O. Valdiserri, MD, MPHa Andrew D. Forsyth, PhDa Vera Yakovchenko, MPHa Howard K. Koh, MD, MPHb “If you cannot measure it, you cannot improve it.” —Lord Kelvin

Reaping the prevention benefits of highly active antiretroviral treatment: policy implications of HIV Prevention Trials Network 052.

PURPOSE OF REVIEWnThis review explores the policy implications of findings from the HIV Prevention Trials Network (HPTN 052) treatment as prevention (TasP) study.nnnRECENT FINDINGSnTo date, the potential of antiretrovirals to prevent sexual transmission of HIV by infected persons has been grounded in observational cohort, ecological, mathematical modeling, and meta-analytic studies. HPTN 052 represents the first randomized controlled trial to test the secondary prevention benefit of HIV transmission using antiretroviral treatment in largely asymptomatic persons with high CD4 cell counts.nnnSUMMARYnThe US National HIV/AIDS Strategy has among its key goals the reduction of incident HIV infections, improved access to quality care and associated outcomes, and the reduction in HIV-associated health disparities and inequities. HPTN 052 demonstrates that providing TasP, in combination with other effective prevention strategies offers the promise of achieving these life-saving goals. But HPTN 052 also highlights the need for cautious optimism and underscores the importance of addressing current gaps in the HIV prevention, treatment, and care continuum in order for TasP strategies to achieve their full potential. Among these are necessary improvements in the capacity to expand HIV testing, facilitate effective linkage and retention in care, and improve treatment initiation, maintenance, and virus suppression.

thirty years of aiDs in ameriCa: a story of infinite hope

The year 2011 marks the thirtieth anniversary of the first case reports in the United States of what we now know to be end-stage HIV disease. This chronological milestone provides an opportunity to reflect upon the changing context of the American HIV/AIDS epidemic. Using two seminal documents as a framework, the 1986 Institute of Medicine Report, Confronting AIDS, and the 2010 National HIV/AIDS Strategy, this descriptive analysis details our accomplishments in addressing the domestic U.S. epidemic and outlines what remains to be done on the long road to eradication of HIV disease. The past three decades have witnessed tremendous biomedical and behavioral advances in preventing, diagnosing, and treating HIV disease. However, to fully realize the promise of these scientific advances, such that we achieve the vision of the National HIV/AIDS Strategy, we must develop effective strategies to surmount a number of salient challenges, including: unbalanced combinations of prevention interventions; programs that are not of adequate scale to achieve population-level results; systems of service delivery that do not function in an integrated fashion; and social and economic structures that increase the vulnerability of populations who are at risk for or living with HIV disease.

Aligning resources to fight HIV/AIDS in the United States: funding to states through the US Department of Health and Human Services.

Background:In response to the first U.S. National HIV/AIDS Strategy released in July 2010, we assessed how HIV/AIDS funding is spent by the Department of Health and Human Services (HHS) and how these resources align geographically with the HIV/AIDS epidemic according to various measures. Methods:Estimated FY2010 spending information was gathered from HHS agencies, including state/territory-level spending by prevention, care, and treatment services of the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), and Substance Abuse and Mental Health Services Administration (SAMHSA) - as well as Centers for Medicare and Medicaid Services (CMS). HHS funding is presented descriptively by state in the context of living HIV and AIDS case numbers and rates. Results:Nearly US

A State-Level Analysis of Social and Structural Factors and HIV Outcomes Among Men Who Have Sex With Men in the United States

16 billion went to discretionary and entitlement spending, 77% of which supported or provided care and treatment by CMS (Medicare, Medicaid) and HRSA; the remainder to research, prevention, and other activities. For states and territories overall, funding was highly correlated with living AIDS case numbers (R2 = .88) as well as living HIV case numbers (R2 = .84); funding was far less correlated with case rates (per 100,000 population) for AIDS (R2 = .35) or HIV (R2 = .42). Conclusions:HHS HIV/AIDS funding, overall, is well correlated with the number of HIV/AIDS cases in each state/territory. Future assessments should capture information on who is being served, where, and how.

Hepatitis C Virus Treatment and Injection Drug Users: It Is Time to Separate Fact From Fiction

We apply a social determinants of health model to examine the association of select social and structural influences on AIDS diagnosis rates among men who have sex with men (MSM) in the U.S. states. Secondary data for key social and structural variables were acquired and analyzed. Standard descriptive and inferential statistics were used to examine bivariate and multivariate associations of selected social and structural variables with estimated rate of Stage 3 HIV infection (AIDS) per 100,000 MSM in 2010. We found that living in states with a higher demographic density of lesbian, gay, bisexual, and transgender persons is independently associated with lower AIDS diagnosis rates among MSM. In addition, we found that greater income inequality and higher syphilis rates among men were associated with greater AIDS diagnosis rates among MSM, which may be attributable to state policy environments that underinvest in social goods that benefit population health, and to the fact that ulcerative sexually-transmitted infections increase biological risk of HIV transmission and acquisition. To end the epidemic in the U.S., it will be critical to identify and address state-level social and structural factors that may be associated with adverse HIV outcomes for MSM.

Breaking the Silence on Viral Hepatitis

We are witnessing revolutionary advances in the treatment of hepatitis C virus (HCV) infection. The development of medications that can be taken orally for shorter periods and with fewer adverse effects than the older regimens of injected pegylated interferon and ribavirin (1) has initiated a profound change in our approach to treating this disease. It is now possible to cure many more infections and thus reduce life-threatening occurrences of cirrhosis and hepatocellular carcinoma, which can lead to the need for liver transplantation or take the lives of those waiting for a donor liver. However, as widely reported in the press, these impressive new pharmacotherapies are associated with stunning costs that threaten their widespread use (2). Hepatitis C virus infection is common in injection drug users, who are often thought to be poor candidates for HCV treatment due to concerns about co-occurring psychiatric and other medical disorders as well as ongoing drug use, which can lead to a lack of adherence and risk for reinfection. These concerns are not unique to HCV therapy and were previously raised with the advent of highly active antiretroviral therapy for HIV, although studies suggested that drug users with HIV could achieve adherence levels similar to those of populations that do not use drugs (3). Furthermore, many of these concerns substantially affect current treatment requirements. For example, Medicaid providers in 35 states and the District of Columbia have requirements related to refraining from use or abuse of drugs or alcohol before HCV treatment (4). These requirements range from demonstration of 3 months to 1 year or more free of substance use. Some states do not distinguish between alcohol use and alcohol use disorders; some impose these requirements only on persons with a history of diagnosis of a substance use disorder, and some do not distinguish between active substance use and treatment and recovery from a substance use disorder. Although we must acknowledge that such policies are necessary due to the high cost of HCV treatment and have been effective in controlling HCV treatment costs, they also block access to many persons who would benefit from curative treatment. An approach that considers a persons stability in treatment of their substance use disorder as well as severity of HCV or liver fibrosis would be a more rational approach to treatment in this population. Studies have shown that persons receiving treatment of substance use disorders who have achieved sobriety have HCV treatment outcomes similar to those without histories of associated substance use (5). Further, predictors of positive HCV treatment outcomes have been described for drug users and include access to evidence-based treatments for opioid use disorders, including medication-assisted treatment with opioid therapies and adherence to these treatments (6). Treatment of HCV has been successfully implemented in the context of opioid treatment programs in which directly observed therapy can be provided for management of opioid use disorder as well as HCV (6). These programs offer daily administration of opioid medications, including methadone or buprenorphine/naloxone, and medical assessment for response to medication and adverse effects. Sustained viral response rates from these programs approximated those from clinical trials involving persons with HCV infection without substance use disorders. Findings from these studies show that the best outcomes occur in persons who have ceased injection and other drug use (5, 6). Positive outcomes for drug users receiving HCV treatment in the context of ongoing treatment of opioid use disorders are not unexpected. Opioid treatment programs are structured to provide medically supervised opioid administration and any needed clinical services, including the administration of other prescribed medications daily. This approach is particularly well-suited to provision of medication treatment of illnesses that depend on high rates of adherence. In fact, a case can be made that persons participating in such treatment programs are among the best candidates for HCV treatment with the new therapies because adherence can be supported and witnessed by medical staff and any treatment-related adverse effects closely monitored, thus increasing the likelihood of successful outcomes. The observation that HCV treatment successes have been reported in drug users receiving older, interferon-based regimens, known to be associated with substantial adverse effects, is especially noteworthy. Newer, all-oral treatments are associated with fewer adverse effects (1), further decreasing the potential for treatment withdrawal. Newer HCV medications are expected to eliminate the virus in most persons who receive treatment (1). Rates of reinfection in persons with a history of injection drug use, although lower than the incident rate of HCV infection in this population (7), are still an important consideration. Drug use disorders, similar to most chronic conditions, can be difficult to successfully treat. Relapse is a risk and occurs often. High-risk behaviors associated with relapse to injection drug use present a risk for HCV reinfection (8). This reality underscores the need for continued engagement and retention in treatment of substance use disorders for as long as clinically indicated. Persons with histories of HCV and injection drug use should be advised to continue medication-assisted treatment with medications approved by the U.S. Food and Drug Administration, such as methadone, buprenorphine/naloxone, or injectable naltrexone (9), indefinitely to decrease the risk for relapse to high-risk behaviors that may be associated with reinfection and transmission of HCV. Lowering rates of HCV in this population would be furthered by early detection, intervention, and maintenance medication-assisted treatment. This would help to reduce the risk for HCV by decreasing the pool of persons who would be most likely to transmit it. On the basis of ongoing surveillance, we know that the highest rates of HCV infection in the United States occur in persons with substance use disorders and, specifically, in injection drug users, most of whom are opioid-dependent. Highly effective and well-tolerated treatment is now available for both conditions, can be provided in clinical settings that foster adherence, and will help to ensure positive outcomes. Our approaches to treating HCV among persons with substance use disorders must be based on evidence-informed practice. Drug users can be successfully treated for substance use disorders, enter recovery, and live productive lives. Now we have the means to cure them of concurrent HCV infection, further improving their quality of life. Treating HCV in persons who are receiving care for their substance use disorders is consistent with good medicine and sound public health.

Improving outcomes along the HIV care continuum: Paying careful attention to the non- biologic determinants of health

Until recently, the silent epidemic of viral hepatitis has eluded a unified national public health strategy for controlling morbidity and mortality. Consequently, untreated chronic viral hepatitis affects between 3.5 and 5.3 million Americans and continues to fuel rising rates of progressive liver disease, liver failure, and liver cancer (1). Chronic hepatitis C virus (HCV) infection affects some 2.7 million noninstitutionalized Americans (2), represents the leading indication for liver transplantation in the United States (3), and has caused more deaths annually than HIV since 2007 (4). Although effective vaccination strategies have contributed to a decline in new cases of acute hepatitis B virus (HBV) since 1990, cases of acute HCV increased by 44% in 2011 compared with 2010, with the largest increases among persons younger than 29 years (5). This increase is believed to reflect a trend in more cases of HCV among adolescent and young adults who inject drugs (5). Although many community leaders and organizations have made valuable, individual contributions to address these issues, a coordinated national approach to tackling viral hepatitis had been lacking until 2011, when the U.S. Department of Health and Human Services (HHS) unveiled the nations first Action Plan for the Prevention, Care and Treatment of Viral Hepatitis in the United States (6). The plan spurred leaders throughout the country to join forces to improve health outcomes for individuals and communities and focused on 6 fundamental priorities: educate providers and communities about viral hepatitis; improve diagnosis and treatment to prevent liver disease; strengthen our ability to detect outbreaks and monitor the sequelae of chronic viral hepatitis; eliminate vaccine-preventable viral hepatitis, including perinatal transmission of HBV; reduce viral hepatitis transmission associated with drug use; and protect patients and workers from health careassociated viral hepatitis. These priorities represent a call to action to advance both prevention and treatment of viral hepatitis. Since the plans release, persons at both the federal and community levels have added their voices to its call to action. In 2011, the White House issued a proclamation raising awareness about World Hepatitis Day and has since hosted annual national meetings to bring attention to the estimated 500 million persons worldwide who are chronically infected with hepatitis B and C. Policymakers are implementing the Patient Protection and Affordable Care Act to bring health insurance coverage to persons who may have been previously denied coverage due to a preexisting condition of chronic viral hepatitis. Since 2012, advocates have introduced and implemented National Hepatitis Testing Day on May 19, featuring education and early detection activities. The Centers for Disease Control and Prevention has developed new educational campaigns (such as Know More Hepatitis), introduced new online risk assessment tools to help people easily determine their risk status and access resources, and disseminated new outreach materials in multiple Asian languages. In 2013, the U.S. Preventive Services Task Force (USPSTF) recommended screening for hepatitis C in all persons born between 1945 and 1965 (7). The potential, afforded by these guidelines, to diagnose hundreds of thousands of infected baby boomers represents a major advance in public health. Examples also abound in the community. Advocates committed to hepatitis B elimination have joined to create Hep B United, a national campaign supporting local community coalitions that promote HBV awareness and action. Medical leaders in birthing hospitals have rallied around new efforts for delivering HBV vaccination as a birth dose to eliminate perinatal transmission of hepatitis B. Civil rights agencies have reinvigorated efforts to eliminate discrimination against health profession students with chronic viral hepatitis. And, in a fast-moving arena, private industry is developing a range of new treatments, making a cure for hepatitis C possible for more patients. In response to the burgeoning new treatment options, professional organizations have joined together to develop and release hepatitis C treatment guidelines reflecting the dynamic pace of drug development. One example of how HHSs action plan is breaking the silence around viral hepatitis can be found in a recent national gathering of expert consultants convened to identify approaches for confronting the rising cases of HCV among young persons who have recently transitioned from oral opioid abuse to drug injection (8). The consultants observations underscored gaps in current surveillance, program, and research activities that will inform future federal directions and priorities. In addition to the consultants endorsement of intensified efforts to prevent drug abuse and provide developmentally appropriate therapy for young persons with opioid addiction, they advocated strongly for an expansion of HCV test-and-treat strategies as a prevention method. Of note, modelers exploring the feasibility of interferon-free treatment as prevention report that scaling up antiviral treatment could reduce both incidence and prevalence among injection drug users (9). Treatment as prevention, which has emerged as a viable strategy for HIV, could offer similar promise for HCV, especially among injection drug users. Despite the obvious differences between HIV and HCV and the surrounding contexts, achieving success in both arenas will require the expertise and full collaboration of many partners. We are encouraged by the actions taken since the plans release in 2011, but more remains to be done. We need new partners, heightened commitment, and concrete evidence that our efforts are making a difference for the health of Americans. Because the 2011 plan did not outline specific action steps beyond 2013, the HHS has released an updated version of the Viral Hepatitis Action Plan for 20142016 (10). The updated plan builds on the goals of its predecessor but is enhanced: It spells out specific actions to be undertaken by federal partners in 20142016, emphasizes the need for a comprehensive national response by calling out potential contributions of clinical and other nongovernmental partners, and expands the focus on evaluation with the addition of specific metrics to monitor the plans 4 major goals. The framework and vision offered by this updated plan will continue to provide a critical platform for medical, public health, and community actions. In light of its release, we call for further commitments to break the silence, stop this epidemic, and propel our nation toward a healthier future where viral hepatitis no longer exerts such a profound toll in morbidity and mortality.