Macías, JuanLópez-Cortés, Luis FTéllez, FranciscoRecio, EvaOjeda-Burgos, GuillermoRíos, Maria JoséRivero-Juárez, AntonioDelgado, MarcialRivas, JeremíasPineda, Juan A2016-08-092016-08-092015-12-07Macías J, López-Cortés LF, Téllez F, Recio E, Ojeda-Burgos G, Ríos MJ, et al. Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection. PLoS One. 2015;10(12):e0143492.http://hdl.handle.net/10668/2345Journal Article; Research Support, Non-U.S. Gov't; TRIAL REGISTRATION ClinicalTrials.gov NCT01529073.BACKGROUND Nitazoxanide (NTZ) plus pegylated interferon and ribavirin (Peg-IFN/RBV) improved the sustained virological response (SVR) achieved with Peg-IFN/RBV in hepatitis C virus genotype 4 (HCV-4)-monoinfected patients. There are no data currently on the efficacy of Peg-IFN/RBV plus NTZ for human immunodeficiency virus (HIV)/HCV-4 coinfection. Therefore, the objectives of this clinical trial were to assess the efficacy and to evaluate the safety of Peg-IFN/RBV plus NTZ in HIV/HCV-4-coinfected patients. PATIENTS AND METHODS This was an open-label, single arm, multicenter phase II pilot clinical trial (NCT01529073) enrolling HIV-infected individuals with HCV-4 chronic infection, naïve to HCV therapy. Patients were treated with NTZ 500 mg bid for 4 weeks, followed by NTZ 500 mg bid plus Peg-IFN alpha-2b 1.5 μg/kg/week plus weight-adjusted RBV during 48 weeks. Analyses were done by intention-to-treat (ITT, missing = failure). A historical cohort of HIV/HCV-4-infected patients treated with Peg-IFN alpha-2b and RBV at the same area was used as control. RESULTS Two (9.5%) of 21 patients included in the trial compared with 5 (21.7%) of 23 patients included in the historical cohort achieved SVR (SVR risk difference, -12.2%; 95% confidence interval, -33.2% to 8.8%; p = 0.416). Virological failure was due to lack of response in 13 (62%) individuals recruited in the trial. Two (9.5%) patients included in the trial and two (9.5%) individuals from the historical cohort discontinued permanently due to adverse events. CONCLUSIONS No increase in SVR was observed among HIV/HCV-4-coinfected patients receiving Peg-IFN/RBV plus NTZ compared with a historical cohort treated with Peg-IFN/RBV. Interruptions due to adverse events of Peg-IFN/RBV plus NTZ were similar to those of dual therapy.enBrazoCoinfecciónIntervalos de confianzaGenotipoInfecciones por VIHHepacivirusHumanosAnálisis de la intención de tratarInterferon-alfaGlicoles de polietilenoRibavirinaTiazolesMedical Subject Headings::Anatomy::Body Regions::Extremities::Upper Extremity::ArmMedical Subject Headings::Diseases::Virus Diseases::CoinfectionMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Confidence IntervalsMedical Subject Headings::Phenomena and Processes::Genetic Phenomena::GenotypeMedical Subject Headings::Diseases::Immune System Diseases::Immunologic Deficiency Syndromes::HIV InfectionsMedical Subject Headings::Organisms::Viruses::Hepatitis Viruses::HepacivirusMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic::Intention to Treat AnalysisMedical Subject Headings::Chemicals and Drugs::Biological Factors::Intercellular Signaling Peptides and Proteins::Interferons::Interferon Type I::Interferon-alphaMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Alcohols::Glycols::Ethylene Glycols::Polyethylene GlycolsMedical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleosides::Ribonucleosides::RibavirinMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Sulfur Compounds::Thiazolesresearch article26640956open access10.1371/journal.pone.01434921932-6203PMC4671604