This article is more than 5 years old. Information may no longer be current.
Sofosbuvir/ribavirin regimen led to SVR among patients with HIV, HCV
Click Here to Manage Email Alerts
A majority of treatment-experienced and treatment-naive patients with HIV and hepatitis C virus achieved sustained virologic response after treatment with sofosbuvir and ribavirin, according to new research data.
Mark S. Sulkowski, MD, of Johns Hopkins University School of Medicine, and colleagues conducted a phase 3 trial with 223 patients coinfected with HIV and HCV infection from 34 treatment centers in the United States and Puerto Rico between August 2012 and November 2013. Treatment-naive patients with HCV genotype 2 or 3 (n=68) received 400 mg sofosbuvir (Sovaldi, Gilead Sciences) once a day and weight-based ribavirin twice a day for 12 weeks, whereas treatment-naive patients with HCV genotype 1 (n=114) and experienced patients with HCV genotype 2 or 3 (n=41) received the same treatment for 24 weeks. Patients received antiretroviral therapy with HIV RNA levels ≤50 copies/mL and had a CD4 T-cell count >200 cells/mcL or were untreated with a CD4 T-cell count >500 cells/mcL.
Mark S. Sulkowski
Research showed that 76% (87/114) of treatment-naive patients with HCV genotype 1, 88% (23/26) with HCV genotype 2 and 67% (28/42) with genotype 3 achieved SVR at 12 weeks of therapy. Virologic relapse occurred in the 27 patients. Of the 41 treatment-experienced patients, 92% (22/24) with HCV genotype 2 and 94% (16/17) with HCV genotype 3 achieved SVR at 12 weeks. Two patients experienced HCV virologic breakthrough, and seven patients discontinued treatment due to an adverse event. The most common adverse events found among the patients were nausea, headache, insomnia and fatigue.
“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,” the researchers wrote. “Further studies of this oral regimen in diverse populations of coinfected patients are warranted.”
Disclosure: See the study for a full list of relevant financial disclosures.
Perspective
Back to Top
Kristin Englund, MD
The medication sofosbuvir has been making lots of news, as it is a wonderful breakthrough in the treatment of hepatitis C. Now that it has been shown clearly to be tolerated and work well in our HIV coinfected patients is even more important, as HIV coinfected patients tend to progress more rapidly. As Dr. Saag brings up, though, it will not get widespread use due to its stunningly high cost.
Perspective
Back to Top
William Carey, MD
This landmark publication established the effectiveness of modern HCV treatment in the HIV-coinfected community where advanced liver disease from HCV is a common cause of disability and death. Most of these individuals are taking a number of medications. The problem of drug-drug interactions has been a substantial one. Along comes sofosbuvir, an oral agent with limited or no interaction with HAART drugs. Combined with ribavirin, high HCV eradication rates are seen with only 3 to 6 months of treatment (rather than the usual 12-month regimens using interferon).
Important points:
1. Drug-drug interactions in this study were seen only when atazanavir was part of HIV treatment.
2. Premature discontinuation of therapy was infrequent (3%-4%)
3. For those with the most common genotype (genotype 1), the eradication rate was more than 80% for those who took the full course of therapy.
4. For HCV genotype 2, 3 months of therapy seemed adequate (88% eradication), and for genotype 3, 6 months of therapy yielded a 94% eradication rate.
In summary, treatment of hepatitis C in this particularly vulnerable group of individuals is now highly successful using all-oral therapy for 6 months or less. Not addressed by this study is the important societal cost of treatment. A 24-week course of treatment is estimated to be $189,000 (for 12 weeks “only” $94,500). It is important to recognize that additional all-oral therapies are in the pipeline, some of which have promise with even shorter treatment periods.
Click Here to Manage Email Alerts