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Near-100% SVR12 With 8 Weeks of Sofosbuvir/Ledipasvir in German HIV+/HIV- Cohort
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15th European AIDS Conference, October 21-24, 2015, Barcelona
Mark Mascolini
Sixty-nine of 70 people in a German HCV cohort attained a 12-week sustained virologic response (SVR12) after 8 weeks of sofosbuvir/ledipasvir (Harvoni) [1]. All 7 people with HIV coinfection and most patients with unfavorable risk profiles also reached SVR12.
In the phase 3 ION-3 trial, HCV-monoinfected, genotype 1, treatment-naive people without cirrhosis had an excellent response rate with 8 weeks of sofosbuvir/ledipasvir [2]. European guidelines recommend this 8-week strategy for certain HCV patients with a lower-risk profile. Clinical investigators working with the German Hepatitis C Cohort (GECCO) assessed responses to 8 weeks of sofosbuvir/ledipasvir (SL8) in their 8-center group of HCV patients. The analysis included everyone taking once-daily 400/90-mg sofosbuvir/ledipasvir with a planned 8-week duration.
Among 1157 people who began a direct-acting antiviral regimen in GECCO, 148 (13%) started SL8. Seventy-six of these people were women and 72 men. Median age stood at 52 (interquartile range [IQR] 44 to 58) and median HCV load at 810,000 IU/mL. Twenty-eight people (19%) had HIV infection, and their median CD4 count measured 531 (IQR 346 to 683). All but 4 people had HCV genotype 1, and 26 (18%) had previous HCV therapy. Five people (3%) had cirrhosis according to Fibroscan or APRI score.
Of 105 GECCO patients with 4 weeks of follow-up after SL8, 104 (99%) attained SVR4, including all 14 HIV-coinfected people, all 4 with F4 fibrosis (cirrhosis), all 16 pretreated people, all 10 with a high pretreatment HCV load (above 2 million IU with the Abbott assay or above 6 million with the Roche assay), and the 1 person with genotype 4 HCV. Twelve weeks after SL8 stopped, 69 of 70 people (98.5%) had reached SVR12, including all 7 with HIV coinfection, all 3 with cirrhosis, all 12 pretreated people, and all 9 with a high pretreatment HCV load.
No one stopped SL8 because of side effects or other reasons. The most frequent side effects were headache in 10%, fatigue in 7%, nausea in 3%, and arthralgia in 2%.
GECCO researchers concluded that SL8 yields excellent response rate in clinical practice. They noted that people coinfected with HIV responded as well as HCV-monoinfected patients and that SVR12 rates were high in people who did not meet European guideline recommendations for SL8 because they had F4 fibrosis, genotype 4, a high viral load, or pretreatment.
References
1. Ingiliz P, Christensen S, Mauss S, et al. Sofosbuvir plus ledipasvir for 8 weeks in HCV-mono- and HIV-HCV-coinfected patients: results from the German Hepatitis C Cohort (GECCO). 15th European AIDS Conference, October 21-24, 2015, Barcelona. Abstract PS7/5.
2. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879-1888. http://www.nejm.org/doi/full/10.1056/NEJMoa1402355
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