EFFICACY OF LEDIPASVIR/SOFOSBUVIR IN PEOPLE WHO INJECT DRUGS COINFECTED WITH HIV AND HCV GENOTYPE 1B

Authors

  • D. H. Zhyvytsia Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
  • D. V. Miroshnychenko Zaporizhzhia Regional Center for Prevention and Control of AIDS
  • V. H. Kazeka Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
  • O. D. Petrovska Zaporizhzhia Regional Center for Prevention and Control of AIDS
  • O. V. Samoilenko Zaporizhzhia Regional Center for Prevention and Control of AIDS

DOI:

https://doi.org/10.11603/1681-2727.2018.3.9420

Keywords:

Hepatitis C, HCV/HIV coinfection, Ledipasvir, Sofosbuvir, people who inject drugs

Abstract

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.

Author Biographies

  • D. H. Zhyvytsia, Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine

    Doctor of Science, Associate Professor, «Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine», Head of the Department of Infectious Diseases

  • D. V. Miroshnychenko, Zaporizhzhia Regional Center for Prevention and Control of AIDS

    КУ «Запорізький обласний центр з профілактики та боротьби зі СНІДом» ЗОР, головний лікар

  • V. H. Kazeka, Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine

    «Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine», Assistant Professor of the Department of Infectious Diseases

  • O. D. Petrovska, Zaporizhzhia Regional Center for Prevention and Control of AIDS

    «Zaporizhzhia Regional Center for Prevention and Control of AIDS», Chief Physician

  • O. V. Samoilenko, Zaporizhzhia Regional Center for Prevention and Control of AIDS

    «Zaporizhzhia Regional Center for Prevention and Control of AIDS», Medical resident of the Inpatient Department

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Published

2018-10-12

Issue

No. 3 (2018)

Section

Original investigations

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How to Cite

EFFICACY OF LEDIPASVIR/SOFOSBUVIR IN PEOPLE WHO INJECT DRUGS COINFECTED WITH HIV AND HCV GENOTYPE 1B. (2018). Infectious Diseases – Infektsiyni Khvoroby, 3, 37-41. https://doi.org/10.11603/1681-2727.2018.3.9420