Susanna Naggie, M.D., M cialis online .H.S., Curtis Cooper, M.D., Michael Saag, M.D., Kimberly Workowski, M.D., Peter Ruane, M.D., William J. Towner, M.D., Kristen Marks, M.D., Anne Luetkemeyer, M.D., Rachel P. Baden, M.D., Paul E. Sax, M.D., Edward Gane, M.D., Jorge Santana-Bagur, M.D., Luisa M. Stamm, M.D., Ph.D., Jenny C. Yang, Pharm.D., Polina German, Pharm.D., Hadas Dvory-Sobol, Ph.D., Liyun Ni, M.A., Phillip S. Pang, M.D., Ph.D., John G. McHutchison, M.D., Catherine A.M. Stedman, M.B., Ch.B., Ph.D., Javier O. Morales-Ramirez, M.D.D., Dushyantha Jayaweera, M.D., Amy E. Colson, M.D., Pablo Tebas, M.D., David K. Wong, M.D., Douglas Dieterich, M.D., and Tag Sulkowski, M.D. For the ION-4 Investigators: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1 Globally, an estimated 4 million to 5 million persons are chronically infected with both human immunodeficiency virus type 1 and hepatitis C virus .1 Sufferers who are coinfected with HIV-1 and HCV have higher rates of cirrhosis, hepatocellular carcinoma, and hepatic decompensation than do individuals monoinfected with HCV; they have a higher rate of death from any cause also.2-8 In observational cohort studies, treatment-induced clearance of HCV infection has been connected with decreased morbidity and mortality associated with liver disease.9,10 However, treatment of HCV with interferon and ribavirin in patients who are coinfected with HIV-1 and HCV has historically been connected with low rates of sustained virologic response, high rates of treatment-related cytopenias, and complex interactions with concomitant antiretroviral medicines.14,15 The phase 3 PHOTON-1 and PHOTON-2 studies investigated the safety and efficacy of the nucleotide NS5B polymerase inhibitor sofosbuvir in combination with ribavirin for the treatment of HCV in patients coinfected with HIV-1.
The principal efficacy end point was analyzed with an analysis-of-variance cell means model to estimate the mean differ from the baseline hemoglobin level to the mean level during the evaluation period within each randomization stratum. Estimates of treatment distinctions and corresponding two-sided 97.5 percent self-confidence intervals, with Bonferroni adjustment for group comparisons, were also calculated with the analysis-of-variance model. Because missing data were not imputed, a prespecified per-protocol population analysis and sensitivity analyses with imputation of missing values were performed to handle the potential ramifications of premature withdrawal from the studies .