Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection (SWIFT-C)
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|ClinicalTrials.gov Identifier: NCT02128217|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : October 23, 2017
People who are recently infected with HCV have a great chance of being cured of the infection when they are treated with a combination of two drugs within the first 6 months of being infected. This study is being done to see if a combination of two new drugs in one pill can replace the old drugs to provide a safer, more effective, and better tolerated treatment for new HCV infection. The names of the new drugs are ledipasvir (LDV) and sofosbuvir (SOF), and they will replace pegylated-interferon alfa (PEG-IFN, a drug given as a weekly injection under the skin). The fixed-dose combination of LDV and SOF (LDV/SOF) has been approved by the Food and Drug Administration (FDA).
This study started with participants in Group 1 receiving SOF in combination with RBV, a drug also approved by the FDA, for 12 weeks. There were a total of 17 participants in Group 1 and all completed treatment. All participants were monitored for safety and viral response while on treatment. After completing treatment, all participants were evaluated for a treatment response after the end of treatment.
If the treatment response in Group 1 was high enough, the study design allowed for the possibility to decrease the length of therapy for Group 2 to 8 weeks, using the same treatment. However, this did not occur. Combined with the fact that a new and more effective treatment for chronic HCV has been approved since the study started, Group 2 will now receive 8 weeks of LDV/SOF instead of 12 or 8 weeks of SOF with RBV.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection Hepatitis||Drug: Ribavirin Drug: Sofosbuvir Drug: Ledipasvir/Sofosbuvir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C)|
|Study Start Date :||April 2014|
|Primary Completion Date :||February 28, 2017|
|Study Completion Date :||May 9, 2017|
Experimental: Cohort 1: SOF+weight-based RBV for 12 wks
Follow-up will occur 24 weeks after the end of treatment.
Participants will receive weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV will be based on subject's weight at entry. Changes in weight after entry do not require a change in dose. Doses will only be changed for toxicity management.
Other Name: RBVDrug: Sofosbuvir
Participants will receive one 400 mg tablet of sofosbuvir orally every morning with food.
Other Name: SOF
Experimental: Cohort 2: LDV/SOF for 8 wks
Follow-up will occur 24 weeks after the end of treatment.
Participants will receive one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.
Other Name: LDV/SOF
- SVR12 defined as HCV RNA undetectable (<LLOQ TND) of the assay at 12 weeks after date of last dose of study treatment. [ Time Frame: At 12 weeks after date of last dose of study treatment ]The 12 week measurement will be the measurement obtained closest to 84 days (i.e. 12*7 days), within the window 79 to 112 days inclusive. If a participant has no HCV RNA measurement within this window, then the participant will be considered as having detectable HCV RNA at 12 weeks unless the preceding and subsequent HCV RNA measurements are both undetectable (<LLOQ TND).
- Occurrence of a Grade ≥ 2 adverse event (AE: diagnosis, sign, symptom or laboratory abnormality), Serious AE according to ICH criteria, or treatment-limiting AE (ie, an AE reported as the reason for permanent discontinuation of study treatment) [ Time Frame: From initiation of study treatment to 28 days after last dose of study treatment ]Any event occurring after initiation of study treatment through to 28 days after date of last dose of study treatment will be included (except that an event that is ongoing at the same grade from before start of study treatment will be excluded).
- HCV RNA undetectable during study treatment [ Time Frame: 1, 2, 4, 8 and, for the 12-week regimen, 12 weeks after starting study treatment ]HCV RNA undetectable is defined as an HCV RNA measurement less than the assay lower limit of quantification, target not detected. If there is no measurement at a scheduled time, then the participant will be considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements are undetectable.
- HCV RNA undetectable after end of study treatment [ Time Frame: 2, 4, 8 and 24 weeks after last dose of study treatment ]HCV RNA undetectable is defined as an HCV RNA measurement less than the assay lower limit of quantification, target not detected. If there is no measurement at a scheduled time, then the participant will be considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements are undetectable. This outcome measure is generally referred to as SVR2, SVR4, SVR8 and SVR where SVR means sustained virologic response.
- HCV virologic relapse [ Time Frame: From end of study treatment through to 24 weeks after end of study treatment ]HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable
- Development of SOF or LDV-associated resistance mutations [ Time Frame: Any time from start of study treatment to 24 weeks after end of study treatment ]The set of mutations to be considered will be defined at the time of analysis based on information from other studies available at that time.
- Occurrence of each type of adverse event [ Time Frame: Any time from start of treatment to 24 weeks after end of treatment ]The adverse events to be considered are those used to define the safety primary outcome measure
- Change in HIV-1 RNA from last measurement prior to start of study treatment [ Time Frame: 4 and 12 weeks after start of study treatment (4 and 8 weeks after for the 8-week regimen ]For participants on ART at study entry, these will be categorized as changes from <50 copies/mL to ≥50 copies/mL, or vice versa; for participants not on ART at study entry, quantitative change in log10 HIV-1 RNA will be considered.
- Change in CD4+ cell count from last measurement prior to start of study treatment. [ Time Frame: 12 weeks after start of study treatment (8 weeks after for the 8-week regimen) ]
- Self-reported adherence to SOF [ Time Frame: 1, 2, 4, 8 and, for 12-week regimen only, 12 weeks after starting study treatment ]whether or not a participant reports having taken all doses of SOF
- Self-reported adherence to RBV [ Time Frame: 1, 2, 4, 8 and, for 12-week regimen only, 12 weeks after starting study treatment ]whether or not a participant reports having taken all doses of RBV
- Adherence as measured by SOF pill count [ Time Frame: 1, 2, 4, 8 and, for 12-week regimen only, 12 weeks after starting study treatment ]Proportion of expected SOF doses taken
- Adherence as measured by RBV pill count [ Time Frame: 1, 2, 4, 8 and, for 12-week regimen only, 12 weeks after starting study treatment ]Proportion of expected RBV doses taken
- Self-reported adherence to LDV/SOF [ Time Frame: 1, 2, 4, and 8, for 8-week regimen only, 8 weeks after starting study treatment ]whether or not a participant reports having taken all doses of LDV/SOF
- Adherence as measured by LDV/SOF pill count [ Time Frame: 1, 2, 4, and 8, for 8-week regimen only, 8 weeks after starting study treatment ]Proportion of expected LDV/SOF doses taken
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128217
|United States, California|
|701 University of California, San Diego AntiViral Research Center CRS|
|San Diego, California, United States, 92103|
|801 University of California, San Francisco HIV/AIDS CRS|
|San Francisco, California, United States, 94110|
|United States, Colorado|
|6101 University of Colorado Hospital CRS|
|Aurora, Colorado, United States, 80262|
|United States, Georgia|
|5802 The Ponce de Leon Center CRS|
|Atlanta, Georgia, United States, 30308|
|United States, Illinois|
|2701 Northwestern University CRS|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|201 Johns Hopkins University CRS|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|101 Massachusetts General Hospital (MGH) CRS|
|Boston, Massachusetts, United States, 02114|
|107 Brigham and Women's Hosp. ACTG CRS|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|2101 Washington University Therapeutics (WT) CRS|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|7804 Weill Cornell Chelsea CRS|
|New York, New York, United States, 10010|
|7803 Weill Cornell Upton CRS|
|New York, New York, United States, 10065|
|United States, North Carolina|
|3201 Chapel Hill CRS|
|Chapel Hill, North Carolina, United States, 27516|
|United States, Ohio|
|2401 Cincinnati CRS|
|Cincinnati, Ohio, United States, 45267-0405|
|United States, Pennsylvania|
|6201 Penn Therapeutics CRS|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Rhode Island|
|2951 The Miriam Hospital (TMH) ACTG CRS|
|Providence, Rhode Island, United States, 02906|
|United States, Texas|
|31443 Trinity Health and Wellness Center CRS|
|Dallas, Texas, United States, 75208|
|31473 Houston AIDS Research Team (HART) CRS|
|Houston, Texas, United States, 77030|
|5401 Puerto Rico AIDS Clinical Trials Unit CRS|
|San Juan, Puerto Rico, 00931|
|Study Chair:||Raymond T Chung, M.D.||Massachusetts General Hospital|
|Study Chair:||Susanna Naggie, M.D.||Duke University|