New hope for kids with hepatitis c: drug combo trial launches in cambodia

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Screening phase Inclusion criteria * Aged ≥ 6 years old with weight ≥ 14 kg * Aged \<18 years old * Informed consent obtained with information sheet given and explained before the inclusion visit, the consent form signed by at least one of the 2 parents or legal guardians and oral assent collected if the child ≥ 13 years old, at the latest the day of the inclusion Non-inclusion criteria \- Any concomitant medical condition that, according to the clinical site investigator, would contraindicate the HCV screening Therapeutic phase Inclusion criteria * Aged ≥ 6 years old with weight ≥ 14 kg * Aged \< 18 years old * HCV RNA detectable * HCV treatment naive * In case of HIV coinfection, * HIV-1 infection confirmed according to Cambodian screening policies * On ART for more than 6 months * CD4 cell-count\> 100 cells/μL and \> 15% and HIV viral load \< 1000 copies/mL at inclusion visit * Informed consent obtained with information sheet given and explained before the inclusion visit and the consent form signed by at least one of the 2 parents and oral assent collected if the child ≥ 13 years old, before any sample or drug administration corresponding to the therapeutic phase. Non-inclusion Criteria: * Suspicion of evidence of hepato-cellular carcinoma (HCC) or any other neoplasia * Decompensated cirrhosis * Co-infection with HBV (positive HBsAg) * Advanced/terminal renal disease defined as serum creatinine clearance \< 30 mL/min * Active tuberculosis under treatment * In case of HIV coinfection, * Repeated ART failures and impossibility of prescription of an effective ART regimen * Active opportunistic infection (OI) * Current pregnancy or breast feeding * Use of any drug known to interact with Sofosbuvir or Daclatasvir and for which temporary cessation or dose modification would be impossible * Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study * Concurrent participation in any other clinical trial without written agreement of the two study investigators