Six-Week Ledipasvir/Sofosbuvir in HIV-Positive Patients With Acute HCV
Jürgen Rockstroh from University of Bonn, Germany, presented data on using the combined ledipasvir/sofosbuvir (LED/SOF) for only six weeks in a small group of HIV-positive people diagnosed with acute HCV.
LED/SOF was a fixed dose combination (90 mg/400 mg) taken once-daily. The primary efficacy was the proportion of patients with SVR12 (sustained virological response 12 weeks after the end of treatment). Safety and tolerability data were also collected.
The study enrolled 26 participants with acute HCV infection (defined as within 24 weeks) and chronic HIV infection. All participants were male, 92% were white, with a mean age of 42 years. Mean HCV viral load at baseline was 5.2 log IU/mL (range <LLOQ to 7.3 log). Mean CD4 count was 675 cells/mm3 (range 275 to 1291). All except one participant were on ART.
After 4 weeks of LED/SOF, 85% of patients experienced a SVR (22/26). Of the four virologic failures without SVR at week 4, three relapsed and one was re-infected with HCV after completing the 6 week treatment course. By 12 weeks, there were no additional virologic failures, but two patients had been lost to follow up, causing an SVR-12 response rate of 77%. None of the patients developed any resistance-associated variants.
Of the three patients who experienced virologic relapse by week 4, two had been HCV-infected for more than 22 weeks, bringing them to the cusp of acute HCV infection definition. These three participants who experienced viral relapse had the highest baseline HCV viral loads (all >7.0 log) after the person with re-infection, suggesting that baseline HCV viral load may be a determinant of viral relapse.
Adverse events were reported in 85% of study participants, 2 (8%) of these were grade 3 or 4 events. There were no discontinuations of the drugs and no deaths in the study. There were also no renal abnormalities and no graded creatinine elevations.
The study concluded that shorter course HCV treatment might be a cheaper option in people with acute HCV and lower HCV viral load.
Rockstroh J et al. Ledipasvir/sofosbuvir for 6 weeks in HIV-infected patients with acute HCV infection. 23rd CROI, 22-25 February 2016, Boston. Oral late breaker abstract 154LB.
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