Treatment of Acute Hepatitis C Virus in HIV Co-Infection

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT00845676
• Collaborator: California HIV/AIDS Research Program (Other)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 69
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C; Human Immunodeficiency Virus; HIV Infections	Drug: Pegylated interferon alfa-2a + Ribavirin	Phase 4

Detailed Description

Hepatitis C virus (HCV) infection is one of the most important causes of illness and death among people living with HIV/AIDS. Over 200,000 people in the Unites States, including 37,000 in California, are co-infected with HIV and HCV. In the past, people who had both HIV and HCV often died from AIDS before HCV could cause serious problems. However, with improvements in HIV/AIDS care and treatment, more co-infected people are living longer and thus developing complications from their HCV, including liver scarring (called cirrhosis) and death. HCV infection can also make HIV medications more toxic to the liver, limiting HIV treatment options. Treatment for chronic (or long-term) HCV infection has improved in recent years, but people with HIV are still about half as likely to clear their chronic HCV infection with treatment as HIV-negative individuals. Also, HCV treatment can be very toxic and may have serious side effects for patients, particularly those with HIV.

Recent research suggests that treatment started within the first few months after getting HCV infection (called "acute infection") can result in high treatment response rates for people who do not have HIV. It is not known whether similarly high treatment response rates can also be seen in people with HIV. It has also been shown that each individual's response to the early phases of HCV treatment can predict his or her ability to clear HCV infection after the end of treatment. This study will look at whether it is possible to follow each person's own HCV viral load over time as a measure of treatment success and to tailor each individual's treatment to his or her own response. This idea is called "kinetically guided therapy" and is a new way of individualizing treatment regimen to produce high treatment success rates while minimizing the amount of potentially toxic medications that an individual might not need.

In this pilot study, 20 HIV-infected individuals with acute HCV infection will be treated with HCV therapy for 24 weeks. Because HIV co-infection decreases treatment success in chronic HCV infection, treatment will be started with the strong combination of pegylated-interferon plus ribavirin. However, this protocol will monitor each individual's HCV viral load during the first 12 weeks of treatment and will stop the ribavirin at week 12 if the individual has a good early response and might not need to continue both medications. Using this approach, pegylated interferon will be given for the full 24 weeks of treatment, but ribavirin will be continued for either 12 or 24 weeks, depending on each individual's early response to therapy. The primary endpoint for this study is the percentage of people who have a sustained virologic response to the study treatment. The side effects of treatment will also be measured in order to determine the overall risks and benefits of this approach to treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Acute Hepatitis C Virus in HIV Co-Infection
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pegylated interferon alfa-2a + Ribavirin Pegylated interferon alfa-2a + Ribavirin	Drug: Pegylated interferon alfa-2a + Ribavirin; Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks; Other Names: Pegasys PEG-IFN RBV

Outcome Measures

Primary Outcome Measures

1. Sustained Virologic Response (SVR) [24 weeks]

   Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment

Secondary Outcome Measures

1. Safety and Tolerability of Treatment [48 weeks]

   Number of participants with treatment-associated problems

2. Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype [24 weeks]

   Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Newly acquired HCV infection of 6 months or less duration

• Detectable HCV RNA at study entry

• HIV infection, any CD4 count

Exclusion Criteria:

• Pregnant or intent to become pregnant within 24 weeks of study completion

• Uncontrolled depression

• Other serious liver disease

• Other safety parameters must be met

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital/UCSF	San Francisco	California	United States	94110

Sponsors and Collaborators

• University of California, San Francisco
• California HIV/AIDS Research Program

Investigators

• Principal Investigator: Brad Hare, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Home page of the Positive Health Program, UCSF HIV/AIDS Division at San Francisco General Hospital

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00845676
• Other Study ID Numbers: CHRP ID06-SF-218
• First Posted: Feb 18, 2009
• Last Update Posted: May 18, 2020
• Last Verified: May 1, 2020

• Keywords provided by University of California, San Francisco: Hepatitis C virus; Acute hepatitis C infection; HIV; HCV
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; HIV Infections; Acquired Immunodeficiency Syndrome; Coinfection; Hepatitis; Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a

Study Results

Participant Flow

Recruitment Details	All participants were enrolled at one U.S. clinical site

Arm/Group Title	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Arm/Group Description	Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
Period Title: Overall Study
STARTED	21
COMPLETED	19
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Arm/Group Description	Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Overall Participants	21
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	21 100%
Region of Enrollment (participants) [Number]
United States	21 100%

Outcome Measures

1. Primary Outcome

Title	Sustained Virologic Response (SVR)
Description	Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Arm/Group Description	Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Measure Participants	19
Number [percentage of participants]	62 295.2%

2. Secondary Outcome

Title	Safety and Tolerability of Treatment
Description	Number of participants with treatment-associated problems
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.

Arm/Group Title	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Arm/Group Description	Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
Measure Participants	0

3. Secondary Outcome

Title	Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype
Description	Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.

Arm/Group Title	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Arm/Group Description	Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
Measure Participants	0

Adverse Events

Time Frame	48 weeks
Arm/Group Title	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Arm/Group Description	Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
All Cause Mortality
	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	Experimental: Pegylated Interferon Alfa-2a + Ribavirin
	Affected / at Risk (%)	# Events
Total	13/21 (61.9%)
Blood and lymphatic system disorders
Neutropenia	8/21 (38.1%)	8
anemia	4/21 (19%)	4
Infections and infestations
Virologic breakthrough	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.