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Interferon-free regimen well tolerated in HIV/HCV coinfected patients
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Treatment with an interferon-free regimen of sofosbuvir and ribavirin was well tolerated in patients with HIV/HCV coinfection and yielded improvements in patient-reported outcome scores that were comparable to those achieved by patients with HCV monoinfection, according to recent findings.
“Currently available interferon-free regimens have not only improved efficacy and safety for patients with chronic hepatitis C but also their patient-reported outcomes (PROs), such as health-related quality of life, fatigue, and work productivity,” Zobair M. Younossi, MD, vice president of research and chairman of the department of medicine at Inova Health System in Falls Church, Va., and colleagues wrote in the Journal of Infectious Diseases. “At the present time, it is unclear whether these PRO improvements can also be seen in HIV/HCV patients.”
Zobair M. Younossi
Younossi and colleagues conducted a pooled analysis of the PHOTON-1 and PHOTON-2 phase 3 clinical trials that included 497 HIV/HCV coinfected patients. These studies assessed the safety and efficacy of once-daily sofosbuvir (Sovaldi, Gilead Sciences) 400 mg with ribavirin (RBV) 1,000 mg to 1,200 mg for infection with HCV genotypes 1 through 3. HCV monoinfected control patients were selected from two additional trials — FUSION and VALENCE — that investigated the same interferon-free regimen.
In the PHOTON-1 and PHOTON-2 studies, 87 patients underwent a 12-week treatment regimen with sofosbuvir/RBV, and 410 received 24 weeks of sofosbuvir/RBV. All participants responded to PRO questionnaires before, during and after treatment.
The researchers found that, at baseline, HIV/HCV coinfected patients reported more impairments in PRO scores vs HCV monoinfected participants. During treatment, slight declines in PRO scores (up to –6.8% on a 0-100% scale; P=.0053) were reported by coinfected patients regardless of the duration of treatment, and were comparable to those of HCV monoinfected patients (all P>.05). Among the 413 coinfected patients with SVR12, most of the PRO scores improved (up to +7.6%; P<.0001), which also was similar to monoinfected patients.
Multivariate analysis indicated that HIV/HCV coinfection was associated with baseline impairment in PRO scores (up to –7.6%; P<.002), but not with changes in PRO scores during treatment (all P>.05).
“The combination of both clinical and PRO benefits should lead to the prioritization for treatment HIV/HCV patients given their more aggressive liver disease progression described, even in the HAART era,” the researchers wrote. “We believe that treatment of HIV/HCV patients with these highly effective and safe treatment regimens is certainly good for patients and cost-effective from the societal perspective.”
Disclosure: Younossi is a consultant for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept and Salix.
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