A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

Vertex Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Telaprevir; Biological: Pegylated Interferon Alfa-2a; Drug: Ribavirin; Drug: Highly Active Antiretroviral Therapy (HAART)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467479

VX11-950-115

Details and patient eligibility

About

The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.

Enrollment: 185 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL)

• Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse

• Population B: Peg-IFN/RBV prior null or partial responder

• Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration

• Participant must have positive HIV antibody at Screening

• Participant must have a diagnosis of HIV-1 infection >6 months before Screening

• Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:

  • Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)
  • Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components
  • Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components
  • Boosted atazanavir plus Epzicom®, or equivalent components
  • Raltegravir plus Truvada®, or equivalent components
  • Raltegravir plus Epzicom®, or equivalent components

• Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol

• Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion criteria

• Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1
• Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
• Contraindications to any planned HAART component as per the respective drug labeling information
• Contraindications to Peg-IFN or RBV
• Evidence of hepatic decompensation
• Clinical suspicion of acute hepatitis
• Any other cause of liver disease in addition to hepatitis C
• History of organ transplantation (except cornea and skin)
• Autoimmune-mediated disease
• Participated in any investigational drug study within 90 days before Day 1
• Previous treatment with an HCV protease inhibitor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 3 patient groups

T/PR + HAART Regimen (ATV/r-Based)

Experimental group

Description:

Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

Treatment:

Drug: Highly Active Antiretroviral Therapy (HAART)

Drug: Ribavirin

Biological: Pegylated Interferon Alfa-2a

Drug: Telaprevir

T/PR + HAART Regimen (EFV-Based)

Experimental group

Description:

Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

Treatment:

Drug: Highly Active Antiretroviral Therapy (HAART)

Drug: Ribavirin

Biological: Pegylated Interferon Alfa-2a

Drug: Telaprevir

T/PR + HAART Regimen (RAL-Based)

Experimental group

Description:

Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.

Treatment:

Drug: Highly Active Antiretroviral Therapy (HAART)

Drug: Ribavirin

Biological: Pegylated Interferon Alfa-2a

Drug: Telaprevir