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Ledipasvir/Sofosbuvir Controls Acute HCV in HIV+ Without Highest HCV Loads
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Conference on Retroviruses and Opportunistic Infections (CROI), February 22-25, 2016, Boston
Mark Mascolini
WEBCAST:http://www.croiwebcasts.org/console/player/29747?mediaType=audio&
Ledipasvir/Sofosbuvir (LDV/SOF) for 6 weeks yielded a 12-week sustained virologic response (SVR12) in 77% of HIV-infected people with acute HCV infection [1]. Relapses occurred only in people with the highest pretreatment HCV loads.
No direct-acting antivirals are licensed for acute HCV infection, noted researchers who conducted this study. Current guidelines still recommend 24 weeks of interferon plus ribavirin for acute HCV infection in people with HIV. They conducted this open-label trial to determine whether LDV/SOF controls HCV infection with genotype 1 or 4 virus.
The trial took place at five centers in Germany and one in the UK. Everyone had acute HCV infection for under 24 weeks with HCV genotype 1 or 4. The researchers defined acute infection as being HCV RNA positive after being negative for HCV RNA or anti-HCV antibody in the last 6 months or ALT/AST more than 2.5 times the upper limit of normal in the past 6 months with normal liver function tests in the past year and other causes excluded. Participants had to be taking an antiretroviral regimen consistent with LDV/SOF or not taking antiretrovirals and with no plan to begin.
The 26 participants averaged 41 years in age, 24 where white, and all were men. Eighteen participants had genotype 1a and 8 had genotype 4. CD4 count averaged 675 (range 275 to 1291) and HCV load 5.4 log10 (about 250,000 IU/mL). All but 1 man was taking antiretroviral therapy.
Participants took LDV/SOF for 6 weeks. Twenty-two of 26 men (85%) attained SVR4. The 4 men who did not had virologic failure. Twenty of 26 men (77%) attained SVR12. In addition to the 4 virologic failures, 2 men were lost to follow-up. No new NS5A or NS5B resistance-associated variants emerged. Three of the four men with HCV relapse had pretreatment HCV RNA at or above 7.0 log10 (10 million IU/mL). No one with a pretreatment HCV load at or below 6.9 log10 (about 7.9 million IU/mL) had a relapse. One of 26 men became reinfected during follow-up.
Adverse events developed in 22 participants, including 2 grade 3 or 4 events and 1 serious adverse event (which followed an automobile accident). No one stopped therapy because of adverse events and no one died. Four men had grade 3 or 4 lab abnormalities. There were no renal adverse events or graded creatinine elevations.
The researchers suggested that people with acute HCV infection and a high viral load should be considered for longer therapy with this regimen.
Reference
1. Rockstroh JK, Bhagani S, Hyland RH, et al. Ledipasvir/sofosbuvir for 6 weeks in HIV-infected patients with acute HCV infection. Conference on Retroviruses and Opportunistic Infections (CROI), February 22-25, 2016, Boston. Abstract 154LB.
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