Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs

Inclusion criteria

• ≥18 years of age;
• 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection;
• HCV genotype 1;
• HCV RNA <6 million copies by Roche TaqMan Assay
• No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25-an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]);
• Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks),
• injected with others in past 12 months by self-report;
• Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN);
• Able to speak English;
• No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly;
• for women of childbearing age, pregnancy test negative, not actively nursing, and agree to use birth control during treatment (although LDV-SOF has a "B" rating, consistent with no known evidence of harm, treatment is not urgent for these patients so we will err on the side of caution).

Exclusion criteria

• HIV+ by rapid test or pooled viral load;
• HBV surface antigen +;
• Non-definitive HCV genotype results;
• Previously received treatment for HCV (interferon, ribavirin, or DAA);
• Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]);
• History of any of the following:

• Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
• History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
• History of solid organ or bone marrow transplantation.
• Current treatment for cancer
• Chronic liver disease for non HCV reason, except iron overload (e.g., Wilson's disease, alfa 1 antitrypsin deficiency, cholangitis);
• Use of any prohibited concomitant medications as described in Section 5.2 within 21 days of the Day 1 visit; and
• Known hypersensitivity to LDV, SOF, the metabolites, or formulation excipients.
• No other conditions that preclude study involvement as determined by PI.