Intervention: Eltrombopag
Trial phase: Phase 2 | Phase 3
ATC code: B02BX05
SMILES: CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: All study patients will undergo intervention in this study.

The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).

Eltrombopag: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.

One subject completed the study as planned. Four subjects had to drop out of the study early for different reasons. One subject was not able to start the hepatitis C triple therapy medications due to a medical condition, two subjects discontinued due to lack of virologic response and one subject discontinued treatment due to side effects.
Eligibility criteria:
Inclusion Criteria:

Male and female patients at least 18 years of age.
Require a platelet count below 75 x 10^9 /L at time of screening.
The patients must meet the eligibility criteria for all drugs involved.
Only genotype 1 (a, b, indeterminate, or mixed).
Confirmed history of chronic hepatitis C.
Cirrhotic patients will be included.
Liver imaging within 1 year to exclude hepatocellular carcinoma (HCC) is required in patients with cirrhosis.
Patients without evidence of cirrhosis but meeting platelet criteria will also be admitted to study.
Subjects must be able to provide informed consent, comply with drug administration instructions, and be able to complete each study visit.
Ability to cover costs of ribavirin, interferon, and boceprevir will also be required.
Female subjects are eligible if: Non-pregnant, non-childbearing potential, or of childbearing potential and willing to perform complete abstinence or correctly use a form of birth control during intercourse [barrier method, intrauterine device, hormonal therapy, or surgical sterilization in females or male partner]. They must also be willing to have pregnancy tests performed every 4- weeks until 6 months after completion of ribavirin.
Male study participants must agree to use a condom and their female partner must partake in one of the contraceptive methods discussed above until 6 months after completion of ribavirin therapy.

Exclusion Criteria:

A history of chronic infection (i.e., HIV or HBV) or a previous organ transplantation.
A history of a platelet disorder.
A poorly controlled underlying medical illness (i.e., diabetes, hypertension, coronary artery disease, congestive heart failure, etc.).
Any contraindication to any study drugs as mentioned in their respective prescribing information.
Patients with decompensated cirrhosis defined as current evidence for ascites, encephalopathy, infection or variceal bleeding. All patients should be considered Child-Pugh Class A.
Patients with aminotransferase levels ≥ 500 IU/L will be excluded on presumption of another active liver disease.
Patients must not be pregnant or nursing.
The study physician maintains the right to exclude a patient for a medical condition not listed above or based off laboratory values indicating chronic disease discovered at screening.
Patients with eye disease may be excluded from this study if the ophthalmologist does not recommend treatment.
Subjects with known hypersensitivity reactions (such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin) to study drugs or any component of the products.
Subjects with autoimmune hepatitis, hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), creatinine clearance less than 50 mL/min.
Co-administration of drugs that are highly dependent on CYP3A4/5 for clearance and CYP3A4/5 inducers (See Table 2 in boceprevir prescribing information).