a5329

A5329: Hep C Study

Interferon –Free Therapy for Chronic Hepatitis C Virus Genotype 1 infection in persons with HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy

 

Brief Description: This study is for people who are infected with both HIV-1(the virus that causes AIDS) and HCV (a virus that causes hepatitis; an inflammation of the liver, specifically genotype 1 which is one of the main types of hepatitis C). People participating in the study must be HCV treatment naïve (individuals who have never taken Hepatitis C medications). Treatment for the HCV virus usually consists of a combination of drugs including interferon. New drugs are being developed to treat people who are infected with HCV. These drugs are being tested as a part of drug regimens that do not contain the drug interferon. These regimens could be useful in treating people who are infected with both HCV and HIV because these people often do not respond well to interferon (it does not treat their HCV effectively and they may have complications from taking the drug, such as depression and changes in their blood counts).

Purpose of this Study: This study will test if these drugs can effectively treat HCV and if they are safe and well tolerated in people who have HIV and HCV.

Key Requirements to Enter Study:

·         HIV and HCV infected people 18-70 years old

·         No HIV genotypic resistance to any anti HIV medications prior to study entry

·         No history of virologic failure during treatment for HIV

·         HIV-1 viral load <50 copies/ml

·         On one of the following HIV-1 anti-retroviral (ARV) regimens:

o    raltegravir (Isentress®) 400 mg twice a day or darunavir (Prezista®) 800 mg once a day administered with ritonovir (Norvir®) 100 mg once a day

AND

o    tenofovir(Viread®) plus emtricitabine (Emtriva®) once a day (individual ARV components or Truvada®)  or tenofovir(Viread®)  plus lamivudine (Epivir®)  once a day (individual ARV components  or fixed dose tenofovir/epivir)

·         CD4 cell count ≥ 200 Body mass index (BMI) from  ≥18 to ≤38 kg/

·         HCV treatment naïve (no prior HCV treatment), HCV viral load > 10,000 IU/mL, HCV genotype 1

·         Test to classify liver disease prior to entry

·         No other causes of liver disease

·         Negative pregnancy test

·         Cannot have a pregnant sexual partner

·         Cannot be currently breastfeeding

·         No active depression or uncontrolled mental health disorders

Treatment: The study drugs that will be provided are:ABT-450/r/ABT- 267 (150/100/25mg) by mouth once a day plus ABT-333 (250mg)  by mouth twice a day plus ribavirin 1000- 1200 mg (based on weight) divided into 2 doses (twice a day). Subjects will be treated for either 12 or 24 weeks, but neither you nor your health care provider will be able to choose which duration of medication you will receive.

Duration of Study: All subjects will be followed up to 48 weeks on study.