EFFICACY OF LEDIPASVIR/SOFOSBUVIR IN PEOPLE WHO INJECT DRUGS COINFECTED WITH HIV AND HCV GENOTYPE 1B
DOI:
https://doi.org/10.11603/1681-2727.2018.3.9420Keywords:
Hepatitis C, HCV/HIV coinfection, Ledipasvir, Sofosbuvir, people who inject drugsAbstract
Background. HIV epidemic in Ukraine is concentrated in the most-at-risk groups such as people who inject drugs (PWIDs). Among HIV-infected PWIDs, hepatitis C virus (HCV) coinfection rates range from 50 % to >90 %. Ledipasvir/Sofosbuvir is an oral, once-daily fixed dose combination of Ledipasvir (inhibitor NS5A) and Sofosbuvir (NS5B polymerase inhibitor) for the treatment of chronic HCV infection.
The aim of the work was to assess the safety and efficacy of the use of Lepidapasive/Sofosbuvir in HIV-infected persons with HCV genotype 1b.
Materials and Methods. We conducted uncontrolled, open-label trial explored the safety and efficacy of Ledipasvir/Sofosbuvir in PWIDs coinfected with HIV and HCV genotype 1b. All patients received Ledipasvir/Sofosbuvir as a single fixed-dose combination for 12 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy (SVR 12).
Results. Twenty PWIDs with HIV and HCV genotype 1b were enrolled and treated. SVR 12 rates were 100 % (95 % CI: 83–100 %). The rates of response were similar in men (100 %) and women (100 %), in patients with cirrhosis (100 %) and those without cirrhosis (100 %). Levels of ALT and AST became normal rapidly with treatment. There were no significant changes in estimated GFR or serum creatinine levels over time. The most common adverse events were mild to moderate headache (12 %), fatigue (10 %).
Conclusions. Ledipasvir/Sofosbuvir for 12 weeks provided excellent rates of sustained virologic response in PWIDs coinfected with HIV and HCV genotype 1b, regardless of sex, CD4 cell count, HCV baseline levels or cirrhosis condition.
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