simplifying hcv treatment in rwanda for elsewhere in the developing world: pangenotypic and retreatment study (shared3)

Conditions: Hepatitis C, Chronic

Summary: the main purpose of the study is to determine the antiviral efficacy and evaluate the safety and tolerability of sofosbuvir/ velpatasvir (sof/vel) and sofosbuvir/ velpatasvir/ voxilaprevir (sof/vel/vox) used to treat individuals with chronic hepatitis c virus infection in rwanda adults.

this is an open-label single-arm study that will examine the antiviral efficacy, safety and tolerability of 12 weeks daily therapy with fixed dose combination (fdc) of sof/vel and sof/vel/vox administered respectively in hcv-infected treatment-naïve adult participants and in hcv-infected individuals with a history of virologic failure to sof/ldv or other daa-containing regimen. a total of 100 participants will be enrolled in this portion of the shared study, labelled the "shared 3 study": 60 treatment-naïve participants and 40 individuals with history of virologic failure to sof/ldv or other daa-containing regimen

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * age ≥ 18 years * hcv rna \>1000 iu/ml at screening * for sof/vel arm, hcv treatment-naïve or interferon/ribavirin-experienced * for sof/vel/vox arm, history of virologic failure to sof/ldv or other daa-containing regimen as defined by a quantifiable hcv viral load any time at or after the end of hcv therapy * screening ultrasound excluding hepatocellular carcinoma (hcc) * acceptable laboratory values including: * hemoglobin ≥8.0 g/dl * platelet count ≥40,000/mm3 * ast, alt, and alkaline phosphatase ≤10 × uln * calculated creatinine clearance (crcl) ≥30 ml/min * general good health * ability to comply with the dosing instructions for study drug administration and to complete the study schedule of assessments * if hiv-infected: * the participant must have completed at least 6 months of any approved hiv antiretroviral therapy (art) before starting enrollment * the participant at time of screening and for at least 2 weeks prior to screening must be on art compatible with sof/vel and sof/vel/vox * screening hiv rna \< 200 copies/ml * screening cd4 t-cell count of ≥100 cells/µl * women of reproductive potential must have a negative urine pregnancy test at screening and a negative urine pregnancy test at entry prior to enrollment. exclusion criteria: * current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) * active tuberculosis * other clinically-significant illness (except hcv and/or hiv) or any other major medical disorder that, in the opinion of the site investigator, may interfere with participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically-significant illness (other than hcv/hiv) are also excluded. * active hepatitis b infection * difficulty with blood collection and/or poor venous access for the purposes of phlebotomy * pregnant or nursing female * active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study procedures and treatment

Keywords: hepatitis c direct-acting antiviral rwanda