HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens

Autor: Mamta K. Jain, Deborah Goldstein, Julie H. Ryu, Thai Nguyen-Cleary, Shuping Jiang, Shauna Applin, Stephanie Cox, Moupali Das, Lorenzo Rossaro, Jihad Slim, Gregory D Huhn, Federico Hinestrosa, Moti Ramgopal, David M. Asmuth, Bill Guyer, Richard Haubrich, David Piontkowsky
Jazyk: angličtina
Rok vydání: 2020
Předmět:
RNA viruses
Male
Sofosbuvir
Physiology
HIV Infections
Hepacivirus
Urine
Pathology and Laboratory Medicine
Gastroenterology
Biochemistry
chemistry.chemical_compound
0302 clinical medicine
Immunodeficiency Viruses
Medicine and Health Sciences
Emtricitabine
030212 general & internal medicine
Multidisciplinary
Alanine
Elvitegravir
Hepatitis C virus
Coinfection
Cobicistat
Liver Diseases
virus diseases
Middle Aged
Hepatitis C
Body Fluids
Drug Combinations
Cirrhosis
Medical Microbiology
Rilpivirine
Viral Pathogens
Creatinine
Viruses
Medicine
RNA
Viral
030211 gastroenterology & hepatology
Female
Pathogens
Anatomy
medicine.drug
Research Article
Ledipasvir
Adult
medicine.medical_specialty
Science
Gastroenterology and Hepatology
Tenofovir alafenamide
Microbiology
03 medical and health sciences
Internal medicine
Microbial Control
Retroviruses
Drug Resistance
Viral
medicine
Humans
Tenofovir
Microbial Pathogens
Aged
Pharmacology
Treatment Guidelines
Fluorenes
Health Care Policy
Flaviviruses
business.industry
Adenine
Lentivirus
Organisms
Biology and Life Sciences
HIV
Hepatitis viruses
Health Care
Regimen
chemistry
HIV-1
Benzimidazoles
Antimicrobial Resistance
business
Biomarkers
Zdroj: PLoS ONE
PLoS ONE, Vol 15, Iss 1, p e0224875 (2020)
ISSN: 1932-6203
Popis: IntroductionGuidelines advocate the treatment of HCV in all HIV/HCV co-infected individuals. The aim of this randomized, open-label study (ClinicalTrials.gov identifier: NCT02707601; https://clinicaltrials.gov/ct2/show/NCT02707601) was to evaluate the safety/efficacy of ledipasvir/sofosbuvir (LDV/SOF) co-administered with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/F/TAF (R/F/TAF) in HIV-1/HCV co-infected participants.MethodsParticipants with HIV-1 RNA ResultsOf 150 participants, 148 received ≥1 dose of HIV study drug and 144 received LDV/SOF (72 in each F/TAF group; 83% GT1a, 94% HCV treatment-naïve, 12% cirrhotic). Overall, SVR12 was 97% (95% confidence interval: 93-99%). Black race did not affect SVR12. Of four participants not achieving SVR12, one had HCV relapse, one had HCV virologic non-response due to non-adherence, and two missed the post-HCV Week 12 visit. Of 148 participants, 96% receiving E/C/F/TAF and 95% receiving R/F/TAF maintained HIV suppression at Week 24; no HIV resistance was detected. No participant discontinued LDV/SOF or E/C/F/TAF due to adverse events; one participant discontinued R/F/TAF due to worsening of pre-existing hypercholesterolemia. Renal toxicity was not observed in either F/TAF regimen during LDV/SOF co-administration. In conclusion, high rates of HCV SVR12 and maintenance of HIV suppression were achieved with LDV/SOF and F/TAF-based regimens.ConclusionThis study supports LDV/SOF co-administered with an F/TAF-based regimen in HIV-1/HCV-GT1 co-infected patients.
Databáze: OpenAIRE
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