In a small cohort study, ribavirin combined with a regimen for HIV-1 and hepatitis C genotype 1 coinfection was safe and effective in patients also receiving Prezista.
The study including 22 coinfected patients was published in The Journal of Infectious Diseases. The researchers sought to test the safety and efficacy of Viekira Pak (obitasvir, paritaprevir, ritonavir and dasabuvir, AbbVie) with ribavirin in patients on ART that included Prezista (darunavir, Janssen).
“Though further studies are needed, these findings are important because darunavir is widely used in ART regimens, and patients on darunavir-containing ART often have limited antiretroviral switch options to accommodate HCV therapy,” the study researchers wrote.
They noted that, in a previous study in which healthy subjects were given the drug combination without ribavirin, Prezista trough concentrations dropped by 48% and 43% in those receiving it once daily and twice daily, respectively.
In their own study, the researchers randomized 10 patients to receive a once-daily 800 mg dose of Prezista for at least 14 days before receiving the Viekira Pak/ribavirin combination. The other 12 patients received twice-daily 600 mg doses of Prezista on the same schedule.
All 22 patients had sustained virologic response at 4 weeks and 12 weeks after treatment. There were no reports of relapse at 24 weeks.
All patients had HIV RNA counts of less than 200 copies/mL at 12 weeks, and all but one had less than 40 copies/mL at that time.
Prezista trough levels were reduced by 36% in patients receiving it once daily and by 27% in those receiving it twice daily.
Twenty patients experienced adverse events, most of them minor and including fatigue, decreased hemoglobin, irritability and nausea. One patient had a serious adverse event —colitis and dehydration on day 38 of treatment — which the researchers said was not related to the study drug.
They concluded the drug combination may be an effective way to treat a difficult coinfection.
“The results presented herein provide clinicians with evidence of a safe and effective HCV treatment option for HIV treatment-naive HIV-1/HCV GT1 coinfected patients without darunavir resistance mutations [who] are currently using [once-daily] darunavir-containing ART.”
By Joe Green