Hepatitis C cured in co-infected HIV patients

July 19, 2014

A multicenter team of researchers report that in a phase III clinical trial, a combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C.

"In many settings, hepatitis C is now a leading cause of death among HIV co-infected ," says Mark Sulkowski, M.D., medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis and professor of medicine at the Johns Hopkins University School of Medicine. Approximately one-third of HIV patients in the United States have hepatitis C, with an estimated 7 million co-infected patients worldwide.

Because of poor tolerability to the previous standard of treatments for hepatitis C, including injections of interferon-alpha and medications that can have interactions with anti-retroviral medications used to treat HIV, this population of co-infection patients has been considered difficult to treat. Data from this phase III clinical trial were incorporated into the FDA's approval of the new drug, sofosbuvir, last December, so with this all-oral regimen—sofosbuvir and ribavirin—is considered on-label.

The trial, paid for by the developers of sofosbuvir, Gilead Sciences, is published in the July 23 issue of The Journal of the American Medical Association.

Researchers and doctors enrolled study participants from the United States and Puerto Rico through 34 academic, private practice and community health centers. In total, doctors administered sofosbuvir and ribavirin to a total of 223 HIV-1 patients chronically co-infected with hepatitis C (genotypes 1, 2 or 3) either for 12 weeks (for treatment-naive patients with 2 or 3) or for 24 weeks (for treatment-naive patents with genotype 1 or treatment-experienced patents with genotype 2 or 3). Twelve weeks after treatment ended, researchers tested patients again for hepatitis C infection to determine if treatment was effective.

For treatment-naive patients, 76 percent with genotype 1, 88 percent with genotype 2 and 67 percent with genotype 3 were cured. "We've always termed this to be 'sustained virologic response,'" says Sulkowski, "but we now know that means hepatitis C has been cured." Treatment-experienced patients had even better cure rates: 92 percent for patients with genotype 2 and 94 percent for patients with genotype 3. Seven patients discontinued treatment because of adverse events, but there were no observed adverse effects on HIV or its treatment.

"The likelihood that a patient with chronic, long-standing hepatitis C infection would have spontaneous cure is near zero," says Sulkowski, "so if these patients had not been treated, none would have been cured." Because of this, typically the control group of patients in a clinical trial undergoes the standard-of-care treatment, which for hepatitis C is weekly Interferon injections and twice-daily ribavirin orally. However, neither the investigators nor the potential clinical trial participants were willing to accept a therapy that for HIV co-infected patients had both low efficacy and poor tolerability.

In addition, says Sulkowski, "Doctors and patients alike recognize the idea that it would be difficult, if not impossible, to randomize clinical trial participants to an injectable treatment (interferon) that's linked to many side effects versus an oral treatment (sofosbuvir plus ribavirin)." For these reasons, the clinical trial, named PHOTON-1, was open-label, nonrandomized and uncontrolled. "The PHOTON-1 study represents the first clinical trial to demonstrate that we can cure C in patients with HIV co-infection without the use of interferon," says Sulkowski. "As such, it represents a transformative step in our approach to this therapeutic area."

Explore further: New drug combo cures toughest cases of hepatitis C, hints to future injection-free therapies

More information: Paper: DOI: 10.1001/jama.2014.7734
Editorial: DOI: 10.1001/jama.2014.7734

Related Stories

New drug combo cures toughest cases of hepatitis C, hints to future injection-free therapies

January 15, 2014
Efforts to cure hepatitis C, the liver-damaging infectious disease that has for years killed more Americans than HIV/AIDS, are about to get simpler and more effective, according to new research at Johns Hopkins and elsewhere.

New combination drug therapy proves very effective in Hepatitis C treatments

April 12, 2014
Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials ...

Impressive SVR12 data for once-daily combination to treat HCV genotype 1 patients

April 12, 2014
Results from three Phase III clinical trials (ION-1, ION-2 and ION-3) evaluating the investigational once-daily fixed-dose combination of the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400mg and the NS5A inhibitor ...

Breakthrough treatment for hepatitis C

April 15, 2014
(Medical Xpress)—A breakthrough treatment for hepatitis C that halves treatment time has been developed in an international clinical trial that included The University of Queensland.

New data for HCV genotype 4 patients with simeprevir- and sofosbuvir-based regimens

April 12, 2014
Results from RESTORE , a phase III, multicentre, single-arm, open-label study presented today at the International Liver Congress 2014 showed that simeprevir 150 mg once-daily for 12 weeks in combination with peginterferon ...

New drug combination offers hope to patients with currently untreatable Hepatitis C

November 5, 2013
Hepatitis C is a viral infection which, if left untreated, can lead to severe and potentially fatal liver damage. Existing treatments consist of a combination of drugs, usually ribavirin, pegylated interferon and a protease ...

Recommended for you

Google searches can be used to track dengue in underdeveloped countries

July 20, 2017
An analytical tool that combines Google search data with government-provided clinical data can quickly and accurately track dengue fever in less-developed countries, according to new research published in PLOS Computational ...

MRSA emerged years before methicillin was even discovered

July 19, 2017
Methicillin resistant Staphylococcus aureus (MRSA) emerged long before the introduction of the antibiotic methicillin into clinical practice, according to a study published in the open access journal Genome Biology. It was ...

New test distinguishes Zika from similar viral infections

July 18, 2017
A new test is the best-to-date in differentiating Zika virus infections from infections caused by similar viruses. The antibody-based assay, developed by researchers at UC Berkeley and Humabs BioMed, a private biotechnology ...

'Superbugs' study reveals complex picture of E. coli bloodstream infections

July 18, 2017
The first large-scale genetic study of Escherichia coli (E. coli) cultured from patients with bloodstream infections in England showed that drug resistant 'superbugs' are not always out-competing other strains. Research by ...

Ebola virus can persist in monkeys that survived disease, even after symptoms disappear

July 17, 2017
Ebola virus infection can be detected in rhesus monkeys that survive the disease and no longer show symptoms, according to research published by Army scientists in today's online edition of the journal Nature Microbiology. ...

Mountain gorillas have herpes virus similar to that found in humans

July 13, 2017
Scientists from the University of California, Davis, have detected a herpes virus in wild mountain gorillas that is very similar to the Epstein-Barr virus in humans, according to a study published today in the journal Scientific ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.