We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Original Investigation |

Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV Coinfection

Mark S. Sulkowski, MD1; Susanna Naggie, MD2; Jacob Lalezari, MD3; Walford Jeffrey Fessel, MD4; Karam Mounzer, MD5; Margaret Shuhart, MD6; Anne F. Luetkemeyer, MD7; David Asmuth, MD8; Anuj Gaggar, MD, PhD9; Liyun Ni, MS9; Evguenia Svarovskaia, PhD9; Diana M. Brainard, MD9; William T. Symonds, PharmD9; G. Mani Subramanian, MD, PhD9; John G. McHutchison, MD9; Maribel Rodriguez-Torres, MD10; Douglas Dieterich, MD11; for the PHOTON-1 Investigators
[+] Author Affiliations
1Viral Hepatitis Center, Johns Hopkins University, Baltimore, Maryland
2Duke Infectious Diseases, Duke University, Durham, North Carolina
3Clinical Research, Quest Clinical Research, San Francisco, California
4Internal Medicine, Kaiser Permanente, San Francisco, California
5Philadelphia FIGHT, Philadelphia, Pennsylvania
6Harborview Medical Center, University of Washington, Seattle
7Division of HIV/AIDS, San Francisco General Hospital, University of California, San Francisco
8Internal Medicine, University of California Davis Medical Center in Sacramento
9Liver Disease Therapeutic Area, Gilead Sciences, Foster City, California
10Fundacion De Investigacion San Juan, Puerto Rico
11Department of Medicine–Liver Diseases, Mount Sinai School of Medicine, New York, New York
JAMA. 2014;312(4):353-361. doi:10.1001/jama.2014.7734.
Text Size: A A A
Published online

Importance  Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.

Objective  To determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.

Design, Setting, and Participants  Open-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.

Interventions  Treatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.

Main Outcomes and Measures  The primary study outcome was the proportion of patients with SVR (serum HCV <25 copies/mL) 12 weeks (SVR12) after cessation of HCV therapy.

Results  Among treatment-naive participants, 87 patients (76%) of 114 (95% CI, 67%-84%) with genotype 1, 23 patients (88%) of 26 with genotype 2 (95% CI, 70%-98%), and 28 patients (67%) of 42 with genotype 3 (95% CI, 51%-80%) achieved SVR12. Among treatment-experienced participants, 22 patients (92%) of 24 with genotype 2 (95% CI, 73%-99%) and 16 patients (94%) of 17 (95% CI, 71%-100%) achieved SVR12. The most common adverse events were fatigue, insomnia, headache, and nausea. Seven patients (3%) discontinued HCV treatment due to adverse events. No adverse effect on HIV disease or its treatment was observed.

Conclusions and Relevance  In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR12. Further studies of this oral regimen in diverse populations of coinfected patients are warranted.

Trial Registration  clinicaltrials.gov Identifier: NCT01667731.

Figures in this Article

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview


Place holder to copy figure label and caption
Figure 1.
Flow Diagram of PHOTON-1 Patients

ART indicates antiretroviral therapy; HCV, hepatitis C virus; HIV, human immunodeficiency virus. aPatients could be excluded for more than 1 criterion. See eTable 12 in the Supplement. bPatient who did not receive the study treatment was not included in the efficacy analysis per protocol.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Rates of 12-Week Sustained Virologic Response by Subgroup in Treatment-Naive Patients With Hepatitis C Virus Genotype 1 Receiving 24 Weeks of Sofosbuvir and Ribavirin

The position of the solid squares indicates the rate of virologic response 12 weeks after the end of treatment for each subgroup; the horizontal lines indicate 95% confidence intervals. The vertical line represents the overall rate of sustained virologic response (SVR) for all patients with genotype 1. Body mass index is calculated as weight in kilograms divided by height in meters squared. ARV indicates antiretroviral therapy; NNRTI, nonnucleoside reverse transcriptase inhibitor; PI, protease inhibitor; SVR12, sustained virological response for 12 weeks; and ULN, upper limit of normal.

Graphic Jump Location



Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 3

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

Customize your page view by dragging & repositioning the boxes below.

Related Multimedia

Author Interview

Articles Related By Topic
Related Collections
CME Related by Topic
PubMed Articles