Diana L. Sylvestre

Treating hepatitis C in methadone maintenance patients: an interim analysis.

OBJECTIVE This study evaluates the safety, tolerability, and efficacy of interferon/ribavirin combination therapy in methadone maintenance (MM) patients with active hepatitis C (HCV). End-of-treatment results are presented as an interim analysis of efficacy. METHODS Fifty eligible MM patients with active HCV and concomitant liver fibrosis were treated with interferon/ribavirin combination therapy using standard dosing regimens. Patients with active drug or alcohol use at the start of treatment, severe or untreated psychiatric illness, and/or decompensated liver disease were excluded. RESULTS Treated MM patients were older, had a longer history of HCV infection, a high prevalence of psychiatric illness, and had substantially more liver fibrosis than in previous studies of HCV treatment in non-opioid-dependent populations. Seventy-eight percent completed the 6-12 month course of treatment. The end-of-treatment virologic response rate was 64% in patients completing treatment and 54% on an intent-to-treat basis. CONCLUSION Methadone maintenance patients exhibit a number of factors that make HCV treatment more difficult: they are older, have a higher prevalence of psychiatric illness, and show evidence of more advanced liver disease. Despite this, their end-of-treatment response rate to interferon/ribavirin combination therapy is similar to that of patients without a history of IDU. Further analysis of the sustained virologic response (SVR) rate is planned at the studys completion. These preliminary results show that MM patients are in need of timely HCV diagnosis, and should be considered good candidates for referral and HCV treatment.

Adherence to hepatitis C treatment in recovering heroin users maintained on methadone

Objectives Injection drug users are often denied hepatitis C (HCV) treatment due to concerns about adherence, despite limited data about the impact of such common issues as psychiatric illness and intercurrent drug use. We sought to define the impact of these and other potential adherence barriers in a real-world sample of recovering drug users. Methods We conducted a prospective observational study of 71 methadone-maintained patients who received interferon and ribavirin combination therapy in a community-based clinic with expertise in treating addictive disorders. Adherence measures were conducted with monthly interview, medication counts, and urine toxicology testing. Results Overall, 48 (68%) were adherent, and adherent patients were significantly more likely to achieve a sustained virologic response (42 vs. 4% in nonadherent patients). Patients with and without a prior psychiatric history were similarly adherent (64 vs. 72%, respectively, P>0.5), and the initiation of new psychiatric medications during HCV treatment was associated with improved adherence overall (P=0.02) and in patients that did not report a preexisting psychiatric diagnosis (P=0.04). Trend towards reduced adherence in patients without a period of abstinence was seen before initiating HCV treatment, 46 vs. 72% of those who had been abstinent for at least 1 month (P=0.10). Although occasional drug users were similarly adherent to those who were completely abstinent, patients who relapsed to regular drug use showed a significantly lower level of adherence (P=0.03). Conclusions We conclude that the majority of methadone-maintained drug users can adhere to HCV treatment, even those with psychiatric illness and relatively limited pretreatment drug abstinence. Lack of pre-HCV treatment drug abstinence and regular drug use during HCV treatment may be relative barriers to medication adherence, but the initiation of psychiatric medications during HCV treatment may be a helpful intervention. This report provides further evidence for an individualized approach to HCV treatment that does not categorically exclude patients with potential barriers such as mental illness and limited drug abstinence.

Co-occurring hepatitis C, substance use, and psychiatric illness: Treatment issues and developing integrated models of care

Hepatitis C virus (HCV) infection is transmitted by injection drug use and associated with psychiatric conditions. Patients with drug use or significant psychiatric illness have typically been excluded from HCV treatment trials noting the 1997 National Institutes of Health Consensus Statement on HCV that indicated active drug use and major depressive illness were contraindications to treatment of HCV infection. However, the 2002 NIH Consensus Statement recognized that these patients could be effectively treated for HCV infection and recommended that treatment be considered on a case-by-case basis. Treating HCV infection in these patients is challenging, with drug use relapse possibly leading to psychosocial instability, poor adherence, and HCV reinfection. Interferon therapy may exacerbate preexisting psychiatric symptoms. Co-occurring human immunodeficiency virus or hepatitis B virus provide additional challenges, and access to ancillary medical and psychiatric services may be limited. Patients with co-occurring HCV infection, substance use, and psychiatric illness can complete interferon treatment with careful monitoring and aggressive intervention. Clinicians must integrate early interventions for psychiatric conditions and drug use into their treatment algorithm. Few programs or treatment models are designed to manage co-occurring substance use, psychiatric illness, and HCV infection and therapy. The National Institute on Drug Abuse convened a panel of experts to address the current status and the long-range needs through a 2-day workshop, Co-occurring Hepatitis C, Substance Abuse, and Psychiatric Illness: Addressing the Issues and Developing Integrated Models of Care. This conference report summarizes current data, medical management issues, and strategies discussed.

Treating Hepatitis C Virus Infection in Active Substance Users

Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of on a small but increasing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 National Institutes of Health Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. However, the criteria on which these treatment decisions should be made are unclear. The duration of pretreatment abstinence, concurrent psychiatric illness, intervening drug use, and the potential for injected interferon to cause relapse of drug use may all influence results of treatment for HCV infection. This overview presents preliminary data on the impact of these potential barriers on outcomes of treatment for HCV infection.

Approaching Treatment for Hepatitis C Virus Infection in Substance Users

Although injection drug users represent the majority of incident and prevalent cases of hepatitis C, most lack access to treatment because of concerns about adherence, treatment efficacy, and reinfection. On the basis of an increasing body of evidence suggesting that injection drug users can successfully undergo treatment for hepatitis C virus (HCV) infection, the 2002 National Institutes of Health Consensus Statement on Hepatitis C has recommended that substance users, even those with ongoing drug use, be considered for treatment for HCV infection on a case-by-case basis. However, the criteria on which these treatment decisions should be based are unclear: The duration of pretreatment drug abstinence, comorbid psychiatric illness, intercurrent drug use, and the potential for injected interferon to cause relapse of drug use may all influence results of treatment for HCV infection. This overview summarizes my groups current data about treatment for HCV infection in substance users and the effect of these potential barriers on outcomes of treatment.

Hepatitis C treatment in drug users: perception versus evidence.

What do we know about hepatitis C virus (HCV) treatment? Most of us are familiar with the large registration trials demonstrating that pegylated interferon and ribavirin yield sustained virological response (SVR) rates of 54–56% [1,2]. We know that genotypes 2 and 3 typically respond to treatment in 24 weeks or less, but that genotype 1 is more resistant, requiring treatment for 48 weeks and maybe more [3]. We may acknowledge the importance of weight-based ribavirin dosing in maximizing treatment outcomes [4]. We also understand that certain other factors impact upon virological outcomes, such as high viral load, sex, race, weight, age at the time of infection, degree of hepatic fibrosis, and adherence [3,5].

Hepatitis Infection in the Treatment of Opioid Dependence and Abuse

Many new and existing cases of viral hepatitis infections are related to injection drug use. Transmission of these infections can result directly from the use of injection equipment that is contaminated with blood containing the hepatitis B or C virus or through sexual contact with an infected individual. In the latter case, drug use can indirectly contribute to hepatitis transmission through the dis-inhibited at-risk behavior, that is, unprotected sex with an infected partner. Individuals who inject drugs are at-risk for infection from different hepatitis viruses, hepatitis A, B, or C. Those with chronic hepatitis B virus infection also face additional risk should they become co-infected with hepatitis D virus. Protection from the transmission of hepatitis viruses A and B is best achieved by vaccination. For those with a history of or who currently inject drugs, the medical management of viral hepatitis infection comprising screening, testing, counseling and providing care and treatment is evolving. Components of the medical management of hepatitis infection, for persons considering, initiating, or receiving pharmacologic therapy for opioid addiction include: testing for hepatitis B and C infections; education and counseling regarding at-risk behavior and hepatitis transmission, acute and chronic hepatitis infection, liver disease and its care and treatment; vaccination against hepatitis A and B infection; and integrative primary care as part of the comprehensive treatment approach for recovery from opioid abuse and dependence. In addition, participation in a peer support group as part of integrated medical care enhances treatment outcomes. Liver disease is highly prevalent in patient populations seeking recovery from opioid addiction or who are currently receiving pharmacotherapy for opioid addiction. Pharmacotherapy for opioid addiction is not a contraindication to evaluation, care, or treatment of liver disease due to hepatitis virus infection. Successful pharmacotherapy for opioid addiction stabilizes patients and improves patient compliance to care and treatment regimens as well as promotes good patient outcomes. Implementation and integration of effective hepatitis prevention programs, care programs, and treatment regimens in concert with the pharmacological therapy of opioid addiction can reduce the public health burdens of hepatitis and injection drug use.

Hepatitis C and Addiction

Abstract Hepatitis C (HCV) is the most common blood-borne infection in the US and affects the majority of long-term injection drug users. Despite this, little is known about the natural history and treatment of HCV in this population. This article provides an overview of HCV epidemiology and natural history as it relates to injection drug users, and describes the basis of diagnostic testing and HCV treatment for the addiction provider. It further reviews the data on HCV treatment barriers in IDUs as a means of understanding and assessing HCV treatment candidacy.