scholarly journals Antiretroviral Concentrations in Hair Strongly Predict Virologic Response in a Large Human Immunodeficiency Virus Treatment-naive Clinical Trial

2018 ◽  
Vol 68 (6) ◽  
pp. 1044-1047 ◽  
Author(s):  
Monica Gandhi ◽  
Peter Bacchetti ◽  
Igho Ofokotun ◽  
Chengshi Jin ◽  
Heather J Ribaudo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Immunodeficiency Virus ◽  
Virologic Response ◽  
Human Immunodeficiency Virus Treatment ◽  
Immunodeficiency Virus ◽  
Treatment Naïve

scholarly journals Ledipasvir/Sofosbuvir for 8 Weeks to Treat Acute Hepatitis C Virus Infections in Men With Human Immunodeficiency Virus Infections: Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals

2019 ◽  
Vol 69 (3) ◽  
pp. 514-522 ◽  
Author(s):  
Susanna Naggie ◽  
Daniel S Fierer ◽  
Michael D Hughes ◽  
Arthur Y Kim ◽  
Annie Luetkemeyer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Immunodeficiency Virus ◽  
Hepatitis C ◽  
Hiv Infections ◽  
Virologic Response ◽  
Hcv Rna ◽  
Virus Infections ◽  
Immunodeficiency Virus ◽  
Acute Hcv ◽  
Hiv 1

Abstract Background Current guidelines for the management of hepatitis C virus (HCV) infections provide varying recommendations for the optimal treatment of acute HCV infections. There are limited data from small cohort studies to provide guidance on the best approach to treatment of this important patient population. Methods Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals is an open-label, 2-cohort, Phase 1 clinical trial in which the second cohort assessed the safety and efficacy of 8 weeks of ledipasvir/sofosbuvir for the treatment of acute HCV infections in participants with chronic human immunodeficiency virus (HIV)-1 infections. This final analysis of the second cohort had a planned accrual of 27 participants, based on non-inferiority criteria, compared to the study-defined, historical, sustained virologic response (SVR) of 60% with pegylated-interferon/ribavirin. Results We enrolled 27 men (9 Hispanic; 11 White, non-Hispanic; 5 Black, non-Hispanic; 2 Asian or Pacific Islander; median age 46 years). Most (96%) had HCV genotype-1 infection and 59% had the favorable interleukin 28B CC genotype. The median baseline HCV RNA load was 6.17 log10 IU/mL (interquartile range 4.51 – 6.55). All participants (100%) achieved the primary outcome of a sustained virologic response 12 weeks after the date of the last dose of study treatment (90% confidence interval 90–100%), achieving non-inferiority versus the 60% historic benchmark. No treatment discontinuations occurred. Conclusions This multicenter clinical trial, investigating 8 weeks of ledipasvir/sofosbuvir for acute HCV infections in men with HIV infections, reports a 100% SVR. This study provides the rationale for larger studies of shortened courses of direct-acting antiviral therapies in persons with HIV infections, including those with high baseline HCV RNA loads. Clinical Trials Registration NCT02128217.

scholarly journals Genotypic Changes in Human Immunodeficiency Virus Type 1 Associated with Loss of Suppression of Plasma Viral RNA Levels in Subjects Treated with Ritonavir (Norvir) Monotherapy

1998 ◽  
Vol 72 (6) ◽  
pp. 5154-5164 ◽  
Author(s):  
P. Scott Eastman ◽  
John Mittler ◽  
Reed Kelso ◽  
Chris Gee ◽  
Eric Boyer ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Human Immunodeficiency Virus Type ◽  
Resistance Mutation ◽  
Virologic Response ◽  
Hiv Rna ◽  
Immunodeficiency Virus ◽  
Plasma Rna ◽  
Doubling Times ◽  
Rna Levels

ABSTRACT Ten subjects received 600 to 1,200 mg of the human immunodeficiency virus type 1 (HIV-1) protease inhibitor ritonavir per day. Following 2 weeks of therapy, plasma HIV RNA levels decreased by a mean of 1.57 (range, 0.89 to 1.96) log units. With continued therapy, HIV RNA levels began to rise in eight subjects. The initial rise in plasma RNA levels was temporally associated with the development and quantitative increase in the V82 resistance mutation. Doubling times of the V82A mutant virus were estimated to be 2.4 to 4.8 days. An L63P/A mutation was commonly present at baseline even in subjects with a durable virologic response. The concomitant acquisition of an L63P/A mutation with the V82A/F mutation at the time when plasma RNA levels rebounded suggests a role for the L63P/A mutation in improving the fitness of the V82A/F mutation. Subsequent additional genotypic changes at codons 54 and 84 were often associated with further increases in plasma RNA levels. Ongoing viral replication in the presence of drugs resulted in the appearance of additional genotypic changes, including the L90M saquinavir resistance mutation, and decreased phenotypic susceptibility. The relative fitness of the protease V82A ritonavir resistance mutation and reverse transcriptase T215Y/F zidovudine resistance mutation following drug withdrawal were estimated to be 96 to 98% that of the wild type. Durability of the virologic response was associated with plasma RNA levels at the nadir. A virologic response beyond 60 days was not observed unless plasma HIV RNA levels were suppressed below 2,000 copies/ml, consistent with estimates from V82A doubling times for selection of a single resistance mutation to dominate the replicating population.

scholarly journals Effects of a brief video intervention on treatment initiation and adherence among patients attending human immunodeficiency virus treatment clinics

PLoS ONE ◽  
2018 ◽  
Vol 13 (10) ◽  
pp. e0204599 ◽  
Author(s):  
Mary Spink Neumann ◽  
Aaron Plant ◽  
Andrew D. Margolis ◽  
Craig B. Borkowf ◽  
C. Kevin Malotte ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Treatment Initiation ◽  
Human Immunodeficiency Virus Treatment ◽  
Video Intervention ◽  
Immunodeficiency Virus
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