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

INTRODUCTION: Guidelines 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. METHODS: Participants with HIV-1 RNA <50 copies/mL and chronic HCV-genotype (GT) 1 (HCV treatment-naïve ± compensated cirrhosis or HCV treatment-experienced non-cirrhotic) were randomized 1:1 to switch to E/C/F/TAF or R/F/TAF. If HIV suppression was maintained at Week 8, participants received 12 weeks of LDV/SOF. The primary endpoint was sustained HCV virologic response 12 weeks after LDV/SOF completion (SVR12). RESULTS: Of 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. CONCLUSION: This study supports LDV/SOF co-administered with an F/TAF-based regimen in HIV-1/HCV-GT1 co-infected patients.

Brief Behavioral Treatment for Insomnia in Persons Living with HIV.

This study examined the feasibility and preliminary efficacy of brief behavioral treatment for insomnia (BBTI) for persons living with HIV (PLWH). Of the 22 persons enrolled, 9 were lost before starting treatment, and one dropped out after starting BBTI. Acceptability was rated favorably by those completing the treatment (n = 12). The most common problems pertained to sleep hygiene: variable bedtimes and rise times, watching television, or consuming caffeine. Improvements on sleep outcomes at posttreatment were clinically and statistically significant on questionnaire and sleep diary outcomes. This study supports the overall feasibility of BBTI in PLWH, and the preliminary evidence supports further research on this treatment for PLWH who have insomnia, but dropouts indicate that some individuals may have difficulty initiating treatment.

Agreement between self-reported knowledge and medical record data.

People living with HIV (PLWH) see their providers quarterly to go over their laboratory results and discuss problems with antiretroviral treatment (ART) regimens. Our purpose was to determine whether socially and economically marginalized PLWH were accurate in self-reporting their most recent CD4 count, viral load, and ART regimen, and whether demographic differences influenced self-reporting. We conducted a secondary data analysis based on results from (N = 200) PLWH. We found moderate agreement for CD4 count (k = .58), and viral load (k = .43), but only 43% were able to recall their ART regimens accurately. PLWH ≥ age 50 (k = .77) and those with health insurance coverage (k = .61) were more accurate to self-report CD4. Women were more accurate in reporting viral load than men (k = .53, p = .003 vs. k = .38). These findings suggest that PLWH need multiple modalities of education to relate CD4 counts, viral load, and ART regimens to their personal health understanding.