Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)

Hepatitis C, Chronic Clinical Trial

— SHARED3  

Official title:

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888729
• Other study ID #: PartnersIH
• Status: Recruiting
• Phase: Phase 4
• Start date: August 26, 2019
• Est. completion date: March 2020

Study information

• Verified date: September 2019
• Source: Partners in Health
• Contact: Fabienne Shumbusho, MD
• Phone: +250788559065
• Email: Fshumbusho[@]pih.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• sofosbubir/velpatasvir
SOF/VEL (400 mg/100 mg) FDC once daily
• sofosbubir/velpatasvir/voxilaprevir
SOF/VEL/VOX (400 mg/100 mg/100 mg) FDC once daily

Locations

Country	Name	City	State
Rwanda	Rwanda Military Hospital	Kigali

Sponsors (1)

Lead Sponsor	Collaborator
Partners in Health

Country where clinical trial is conducted

Rwanda, 

References & Publications (1)

Gupta N, Mbituyumuremyi A, Kabahizi J, Ntaganda F, Muvunyi CM, Shumbusho F, Musabeyezu E, Mukabatsinda C, Ntirenganya C, Van Nuil JI, Kateera F, Camus G, Damascene MJ, Nsanzimana S, Mukherjee J, Grant PM. Treatment of chronic hepatitis C virus infection i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12)	Antiviral efficacy of SOF/VEL FDC and SOF/VEL/VOX FDC as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12) in Rwanda	After study completion (week 24)
Primary	Proportion of patients treated with SOF/VEL FDC and SOF/VEL/VOX FDC with a new grade 3 or 4 adverse event as defined by the DAIDS Scales or with premature study drug discontinuation due to an adverse event	Proportion of patients treated with SOF/VEL FDC and SOF/VEL/VOX FDC with a new grade 3 or 4 adverse event as defined by the DAIDS Scales or with premature study drug discontinuation due to an adverse event	After study completion (week 24)
Secondary	Proportion of participants by HCV genotype subtypes with SVR12 after completing treatment with SOF/VEL FDC and SOF/VEL/VOX FDC	Proportion of participants by HCV genotype 4 subtype with SVR12 after completing the study treatment with SOF/VEL FDC and SOF/VEL/VOX FDC	After study completion (week 24)
Secondary	Adherence to SOF/VEL FDC and SOF/VEL/VOX FDC	Proportion of participants with adequate adherence to SOF/VEL FDC and SOF/VEL/VOX FDC measured by pill count >90% of pills taken	After study completion (week 24)
Secondary	Odds ratio for achievement of SVR12 by treatment type for the following variables: age (per 10 year increase), female sex, HIV co-infection, genotype subtype 4r, baseline HCV viral load (per 1 log increase), APRI > 1.0	Odds ratio for achievement of SVR12 by treatment type for the following variables: age (per 10 year increase), female sex, HIV co-infection, genotype subtype 4r, baseline HCV viral load (per 1 log increase), APRI > 1.0	After study completion (week 24)
Secondary	Proportion of HIV co-infected subjects that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment	Proportion of HIV co-infected subjects that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment, with HIV-1 RNA test performed at completion of the study treatment (week 12)	After study completion (week 24)
Secondary	Effect of SOF/VEL FDC and SOF/VEL/VOX FDC and SVR12 on quality of life	Effect of SOF/VEL FDC and SOF/VEL/VOX FDC and SVR12 on quality of life, using the MOS HIV questionnaire, with proportion of patients showing significant improvement on physical quality of life and mental quality of life from pre- to post- treatment	After study completion (week 24)