Examination of Fiscal Management and the Allocation of Care Act Resources US Department of Health and Human Services: Health REsources and Services Administration
INTRODUCTION
HIV/HCV Coinfection
HCV Treatment
Expanding Access to Treatment
Integrating Care: Starting a Coinfection Clinic
Barriers and Key Issues
Conclusion
Resources
References

Integrating Care: Starting a Coinfection Clinic

Care and treatment for HCV coinfection have been successfully integrated into several different venues, including CARE Act–funded clinics, VA programs, and methadone clinics. Many use a multiple-visit model to counsel, educate, screen, vaccinate, diagnose, and assess patients for HCV treatment (Figure 5). People who have opened coinfection clinics agree that the key element is a dedicated, full-time nurse or physician assistant who is able to schedule appointments, educate patients, facilitate support groups, provide one-on-one counseling, work on reimbursement for medications, manage side effects of treatment, and secure case management and transportation services for patients.1,67,68,70,144-147 Most coinfection clinics have a dedicated nurse or doctor who is available by pager on a 24-hour basis; they report that patients do not abuse this service.

The Coinfection Clinic at Alameda County Medical Center, Oakland, CA
In Oakland, CA, Kathleen Clanon and her colleagues established a coinfection clinic in 2001 because so few of their coinfected patients were being treated for HCV by gastroenterologists; less than 10 percent were keeping appointments. The clinic has a monthly coinfection session and weekly support group meetings. Liver biopsies are performed at the HIV clinic by a gastroenterologist who uses a borrowed portable ultrasound machine. Patients recover from the biopsy in the HIV clinic, where they are already accustomed to receiving care. The key elements of the program are as follows:

  • Sufficient funding to hire a dedicated nurse to provide monitoring and support for patients receiving treatment
  • A cooperative relationship with a gastroenterologist, who has become part of the treatment team
  • A patient support group.

figure 5

So far, 35 patients at Alameda County Medical Center have been treated or are currently being treated. “It’s a slow movement and needs to be built up,” says Michael Harank, who coordinates care and facilitates the education and support group.57 The SVR rate among Clanon’s patients is astoundingly high: 53 percent. That rate can be attributed to a combination of factors: favorable HCV genotype, adherence to treatment, prompt management of side effects, consistent support from peers and staff, and eligibility criteria that include abstinence from drugs and alcohol prior to initiating HCV treatment and a CD4 cell count of more than 350/mL.

Preparing for the Future: New Treatments for Hepatitis C
Clinicians and coinfected patients who are reluctant to treat HCV, given the limitations and toxicities of the current treatment, can anticipate therapeutic advances in HCV treatment in the coming years. Despite a promising pipeline of new HCV therapies, pegylated interferon is likely to remain the backbone of HCV therapy for some time, because most new drugs will need to be used in combination with interferon to avoid the development of resistance—an approach paralleling combination therapy for HIV. Coinfected people may need to wait even longer for new drugs, because HCV treatment trials in coinfected people often lag behind trials in people with HCV monoinfection, despite growing pressure from advocates.

Many different types of drugs are in development. Although a trial of an HCV protease inhibitor, BILN-2061, was discontinued, proof-of-concept for this class of drugs was established and two HCV protease inhibitors are in clinical trials.148 Agents in development include helicase and polymerase inhibitors, drugs targeting the internal ribosomal entry site, and small interfering RNA.148

Clinic staff recommend the following approach to treatment:

  • Maintain the full dose of pegylated interferon and ribavirin. Use growth factors instead of dose reduction, and consider pretreatment with erythropoietin.
  • Assess for depression before initiating treatment, and reassess on a monthly basis. Pretreat for depression with selective serotonin reuptake inhibitors if the patient has a history of depression or a moderately high depression score prior to treatment. Switch medication if necessary.
  • Advise patients to drink at least 3 liters of water per day; doing so seems to reduce pain, fatigue, and headaches. Almost all patients who drink sufficient quantities of water report no need for additional pain medication.68
  • Encourage patients to utilize other services that can help them stay in care and manage quality of life.57,68,147

Miriam Hospital’s Immunology Center, Providence, RI
In contrast to many other coinfection treatment providers, Lynn Taylor and her colleagues at the Miriam Hospital do not exclude coinfected drug and alcohol users from HCV treatment. Patients at Taylor’s coinfection clinic often have advanced liver disease and unfavorable HCV genotypes, so the main goals of treatment often are to delay HCV progression and improve liver histology, not necessarily to achieve SVR.

The coinfection clinic opened in 2001 as part of Miriam Hospital’s Immunology Center, which provides CARE Act–funded clinical care to more than 1,000 PLWHA, 43 percent of whom are coinfected. Care and treatment for HIV and HCV are multidisciplinary. Treatment plans are made on an individualized basis. Coordinated psychiatric care, addiction treatment, and home-based case management are provided through collaboration with a community-based mental health agency, and the clinic has a collaborating hepatologist.56

The coinfection clinic takes place on 2 half-day sessions each month. At their first visit, patients receive comprehensive, individualized education. A support group meets once per week for breakfast, and the clinic offers monthly group educational sessions, the opportunity for individual sessions, and educational materials in English and Spanish. Patients often speak with one another on the telephone when they are unable to come to sessions. An interventional radiologist performs liver biopsies, which are not required for treatment. Weekly injections of pegylated interferon are given at the clinic, and patients are given a week’s supply of ribavirin at that time. Directly observed administration of pegylated interferon allows for assessment and management of side effects. The adherence rate for weekly clinic visits has been 99 percent. So far, none of Taylor’s 17 patients has discontinued treatment because of ongoing drug use or relapse. Five patients are currently receiving therapy, and seven have completed 48 weeks of HCV treatment. So far, one patient completing 48 weeks of treatment has achieved SVR.1,56

“This can be done with just two people,” Taylor says.1