Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

Eksperymentalny: HCV GT1a (3-DAA)

Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.

Lek: ombitaswir/parytaprewir/rytonawir i dazabuwir

Tablet; ombitaswir w postaci złożonej z parytaprewiru i rytonawiru, tabletka dazabuwiru

Inne nazwy:

• Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

Eksperymentalny: HCV GT4 (2-DAA)

Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.

Lek: ombitaswir/parytaprewir/rytonawir

Tablet; ombitaswir w skojarzeniu z parytaprewirem i rytonawirem

Inne nazwy:

• Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.

Odsetek uczestników z nawrotem po leczeniu

Nawrót po leczeniu zdefiniowano jako potwierdzone miano RNA HCV ≥ LLOQ między zakończeniem leczenia a 12 tygodniami po przyjęciu ostatniej dawki badanego leku wśród uczestników, którzy ukończyli leczenie z poziomem RNA HCV < LLOQ na koniec leczenia.

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment.