Combination treatment for Hep C associated with favorable response among patients with HIV

July 19, 2014

HIV-infected patients also infected with hepatitis C virus (HCV) who received a combination of the medications sofosbuvir plus ribavirin had high rates of sustained HCV virologic response 12 weeks after cessation of therapy, according to a study in the July 23/30 issue of JAMA, a theme issue on HIV/AIDS. The issue is being released early to coincide with the International AIDS Conference.

Up to 7 million persons worldwide are infected with both human immunodeficiency virus (HIV) and hepatitis C virus. Treatment of this coinfection has been limited due to the need to use interferon (an antiviral protein used to treat HCV) and drug interactions with antiretroviral therapies (ARTs), according to background information in the article.

Mark S. Sulkowski, M.D., of Johns Hopkins University, Baltimore, and colleagues evaluated the rates of sustained virologic response (SVR) (what is clinically considered "cure") and adverse events in 223 patients infected with HIV and HCV (genotypes 1, 2, or 3) who were treated with an interferon-free combination of the drugs sofosbuvir and ribavirin for 12 or 24 weeks. The trial was conducted at 34 treatment centers in the United States and Puerto Rico from August 2012 to November 2013.

Among participants with no prior treatment for HCV, 76 percent with genotype 1, 88 percent with genotype 2, and 67 percent with genotype 3 achieved SVR12 (serum HCV <25 copies>

Seven patients (3 percent) discontinued HCV treatment due to adverse events, of which the most common were fatigue, insomnia, headache, and nausea. No adverse effect on HIV disease or its treatment was observed.

"In this open-label, nonrandomized, uncontrolled study, HIV-infected patients with HCV genotypes 1, 2, or 3 coinfection who received an oral combination of sofosbuvir plus ribavirin for 12 or 24 weeks had high rates of sustained HCV virologic response 12 weeks after cessation of therapy," the authors write. "Further studies of this regimen in more diverse populations of coinfected patients are needed." (doi:10.1001/jama.2014.7734; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

There will also be a digital news release available for this study, including the JAMA Report video, embedded and downloadable video, audio files, text, documents, and related links. This content will be available at 10 a.m. CT Saturday, July 19 at this link.

Editorial: Quantum Leaps, Microeconomics, and the Treatment of Patients With Hepatitis C and HIV Coinfection

Michael S. Saag, M.D., of the University of Alabama School of Medicine, Birmingham, writes in an accompanying editorial that although this study (PHOTON-l) represents a quantum leap forward in the treatment of patients coinfected with HIV and HCV, the current cost of the regimen makes wide-spread use unaffordable.

"When combined with ribavirin, the average wholesale price of a 12- week course of treatment is $94,500 and $189,000 for a 24-week course, as used in the PHOTON-l study. Industry analysts indicate that the pricing of the drug is not based on the cost of ingredients or the duration of therapy, but rather the 'cost per cure.' With more than 185 million HCV seropositive people worldwide with HCV infection and with 4.4 million HCV seropositive persons in the United States, the world simply cannot afford to pay on a 'cost per cure' basis, especially when the majority of persons with chronic infection, an estimated 75 percent, do not progress to cirrhosis or end-stage liver disease over 20 to 30 years."

"Hopefully, competition among the new products coming to market in the next 18 months will result in substantially lower pricing for the drugs. Indeed, the release of the new products will be, perhaps for the first time, a genuine test of whether there is a free market, microeconomic system in the pharmaceutical industry."
-end-
(doi:10.1001/jama.2014.7734; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

The JAMA Network Journals

Related HIV Articles from Brightsurf:

BEAT-HIV Delaney collaboratory issues recommendations measuring persistent HIV reservoirs
Spearheaded by Wistar scientists, top worldwide HIV researchers from the BEAT-HIV Martin Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy (BEAT-HIV Collaboratory) compiled the first comprehensive set of recommendations on how to best measure the size of persistent HIV reservoirs during cure-directed clinical studies.

The Lancet HIV: Study suggests a second patient has been cured of HIV
A study of the second HIV patient to undergo successful stem cell transplantation from donors with a HIV-resistant gene, finds that there was no active viral infection in the patient's blood 30 months after they stopped anti-retroviral therapy, according to a case report published in The Lancet HIV journal and presented at CROI (Conference on Retroviruses and Opportunistic Infections).

Children with HIV score below HIV-negative peers in cognitive, motor function tests
Children who acquired HIV in utero or during birth or breastfeeding did not perform as well as their peers who do not have HIV on tests measuring cognitive ability, motor function and attention, according to a report published online today in Clinical Infectious Diseases.

Efforts to end the HIV epidemic must not ignore people already living with HIV
Efforts to prevent new HIV transmissions in the US must be accompanied by addressing HIV-associated comorbidities to improve the health of people already living with HIV, NIH experts assert in the third of a series of JAMA commentaries.

The Lancet HIV: Severe anti-LGBT legislations associated with lower testing and awareness of HIV in African countries
This first systematic review to investigate HIV testing, treatment and viral suppression in men who have sex with men in Africa finds that among the most recent studies (conducted after 2011) only half of men have been tested for HIV in the past 12 months.

The Lancet HIV: Tenfold increase in number of adolescents on HIV treatment in South Africa since 2010, but many still untreated
A new study of more than 700,000 one to 19-year olds being treated for HIV infection suggests a ten-fold increase in the number of adolescents aged 15 to 19 receiving HIV treatment in South Africa, according to results published in The Lancet HIV journal.

Starting HIV treatment in ERs may be key to ending HIV spread worldwide
In a follow-up study conducted in South Africa, Johns Hopkins Medicine researchers say they have evidence that hospital emergency departments (EDs) worldwide may be key strategic settings for curbing the spread of HIV infections in hard-to-reach populations if the EDs jump-start treatment and case management as well as diagnosis of the disease.

NIH HIV experts prioritize research to achieve sustained ART-free HIV remission
Achieving sustained remission of HIV without life-long antiretroviral therapy (ART) is a top HIV research priority, according to a new commentary in JAMA by experts at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The Lancet HIV: PrEP implementation is associated with a rapid decline in new HIV infections
Study from Australia is the first to evaluate a population-level roll-out of pre-exposure prophylaxis (PrEP) in men who have sex with men.

Researchers date 'hibernating' HIV strains, advancing BC's leadership in HIV cure research
Researchers have developed a novel way for dating 'hibernating' HIV strains, in an advancement for HIV cure research.

Read More: HIV News and HIV Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.