scholarly journals Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study

2020 ◽  
Author(s):  
Kristina M Brooks ◽  
Jose R Castillo-Mancilla ◽  
Mary Morrow ◽  
Samantha MaWhinney ◽  
Sarah E Rowan ◽  
...  
Keyword(s):  
Drug Use ◽  
Linear Models ◽  
Virologic Response ◽  
Directly Observed Therapy ◽  
Hcv Treatment ◽  
Open Label ◽  
Direct Acting Antiviral ◽  
Intention To Treat ◽  
Adherence Data ◽  
Direct Acting

Abstract Background HCV treatment in persons who use drugs (PWUD) is often withheld due to adherence and reinfection concerns. Here, we report treatment outcomes, technology-based adherence data, and adherence predictors in PWUD and/or alcohol. Methods INCLUD was a prospective, open-label study of ledipasvir/sofosbuvir for 12 weeks in PWUD aged 18-70 years. Participants were randomized to wireless (WOT, Wisepill®) or video-based directly observed therapy (vDOT, Emocha®). Drug use was assessed every 2 weeks. Sustained virologic response (SVR) was examined by intention-to-treat and as-treated. Factors associated with missing ≥1 dose(s) between visits were examined using generalized linear models. Results Sixty participants received ≥1 ledipasvir/sofosbuvir dose (47 HIV/HCV, 13 HCV only; 78% male; 22% Black; 25% cirrhotic). Substance use occurred at 94% of person-visits: 60% marijuana, 56% alcohol, 37% methamphetamine, 22% opioids, 17% cocaine, and 20% injection drug use. SVR by intention-to-treat was 86.7% (52/60) and as-treated was 94.5% (52/55). Confirmed failures included 1 relapse, 1 reinfection, and 1 unknown (suspected reinfection). Median (IQR [range]) total adherence was 96% (85-100% [30-101%]) and between-visit adherence was 100% (86-100% [0-107%]). Odds [95% CI] of missing ≥1 dose between visits increased with HIV coinfection (2.94 [1.37, 6.32], p=0.006), Black race (4.09 [1.42, 11.74], p=0.009), methamphetamine use (2.51 [1.44, 4.37], p=0.0.001) and cocaine use (2.12 [1.08, 4.18], p=0.03), and decreased with marijuana use (0.34 [0.17, 0.70], p=0.003) and vDOT (0.43 [0.21, 0.87], p=0.02). Conclusions PWUD achieved high SVR rates with high, but variable, ledipasvir/sofosbuvir adherence using technology-based methods. These findings support efforts to expand HCV treatment in PWUD.

scholarly journals Efficacy and Tolerability of Daclatasvir/Sofosbuvir (Datex) in Patients with HIV-HCV Co-infection

2020 ◽  
Vol 15 (3) ◽  
Author(s):  
Narjes Shokatpour ◽  
Shahnaz Sali ◽  
Batool Daneshpazhouh ◽  
Masoud Mardani
Keyword(s):  
Antiviral Agents ◽  
Real Life ◽  
Virologic Response ◽  
Cd4 Count ◽  
Hcv Treatment ◽  
Direct Acting Antiviral ◽  
Real Life Setting ◽  
End Of Treatment ◽  
Direct Acting ◽  
Iv Drug Use

Background: Treatment of hepatitis C virus (HCV) infection with direct-acting antiviral agents in patients with HCV/human immunodeficiency virus (HIV) co-infection remains controversial due to drug interactions with antiretroviral therapy (ART). Objectives: In this study, we assessed the efficacy and tolerability of daclatasvir/sofosbuvir (DCV/SOF) in patients with HIV-HCV co-infection in the real-life setting in Iran. Methods: A total of 44 patients with HCV-HIV co-infection (genotypes 1, 3, and 4) were treated with DCV/SOF±RBV (ribavirin) (dose-adjusted DCV for concomitant ART). Assessment of risk factors, sustained virologic response at 12 weeks after the end of treatment (SVR12), safety, and serum CD4 count was performed. Results: Most patients were male (95.2%). Four patients were HCV treatment-experienced cases, and 15 had cirrhosis or advanced fibrosis. The most common genotype was 3 (53.5%), followed by 1 (44.2%) and 4 (2.3%). HIV-1 RNA < 50 copies/mL and CD4 count > 250 cells/mm3 were observed in 81.8% and 79.1% of patients, respectively. The highest risk factor was a history of IV drug use (81.8%), followed by using a common syringe (77.3%) and tattooing (70.5%). All patients with or without cirrhosis (100%) completed the HCV treatment course and achieved SVR12. Also. 92.6% of patients on ART had CD4 count > 250 cells/mm3 at the end of treatment. The HCV treatment regimen was well-tolerated. Moreover, 15.9% of patients experienced adverse events (AEs), including anorexia, nausea, diarrhea, palpitations, and anxiety. No serious AEs or discontinuation due to AEs were reported. Conclusions: Our study showed excellent tolerability and efficacy of DCV/SOF±RBV in HIV-HCV co-infected patients with or without cirrhosis.

scholarly journals Patterns of Drug and Alcohol Use and Injection Equipment Sharing Among People With Recent Injecting Drug Use or Receiving Opioid Agonist Treatment During and Following Hepatitis C Virus Treatment With Direct-acting Antiviral Therapies: An International Study

2019 ◽  
Vol 70 (11) ◽  
pp. 2369-2376 ◽  
Author(s):  
Andreea A Artenie ◽  
Evan B Cunningham ◽  
Gregory J Dore ◽  
Brian Conway ◽  
Olav Dalgard ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Drug Use ◽  
Injecting Drug Use ◽  
Hcv Treatment ◽  
Opioid Agonist ◽  
Injection Equipment ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Drug And Alcohol

Abstract Background In many settings, recent or prior injection drug use remains a barrier to accessing direct-acting antiviral treatment (DAA) for hepatitis C virus (HCV) infection. We examined patterns of drug and alcohol use and injection equipment sharing among people with recent injecting drug use or receiving opioid agonist treatment (OAT) during and following DAA-based treatment. Methods SIMPLIFY and D3FEAT are phase 4 trials evaluating the efficacy of DAA among people with past 6-month injecting drug use or receiving OAT through a network of 25 international sites. Enrolled in 2016–2017, participants received sofosbuvir/velpatasvir (SIMPLIFY) or paritaprevir/ritonavir/dasabuvir/ombitasvir ± ribavirin (D3FEAT) for 12 weeks and completed behavioral questionnaires before, during, and up to 2 years posttreatment. The impact of time in HCV treatment and follow-up on longitudinally measured longitudinally measured behaviors was estimated using generalized estimating equations. Results At screening, of 190 participants (mean age, 47 years; 74% male), 62% reported any past-month injecting 16% past-month injection equipment sharing, and 61% current OAT. Median alcohol use was 2 (Alcohol Use Disorders Identification Test–Consumption; range, 1–12). During follow-up, opioid injecting (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.92–0.99) and sharing (OR, 0.87; 95% CI, 0.80–0.94) decreased, whereas no significant changes were observed for stimulant injecting (OR, 0.98; 95% CI, 0.94–1.02) or alcohol use (OR, 0.99; 95% CI, 0.95–1.04). Conclusions Injecting drug use and risk behaviors remained stable or decreased following DAA-based HCV treatment. Findings further support expanding HCV treatment to all, irrespective of injection drug use. Clinical Trials Registration SIMPLIFY, NCT02336139; D3FEAT, NCT02498015.

New Epidemiologic Data Regarding Hepatitis C Virus Infection in Romania

2017 ◽  
Vol 26 (4) ◽  
pp. 381-386
Author(s):  
Mircea Manuc ◽  
Carmen M. Preda ◽  
Corneliu P. Popescu ◽  
Cristian Baicuș ◽  
Theodor Voiosu ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Drug Users ◽  
Antiviral Agent ◽  
Virologic Response ◽  
Advanced Fibrosis ◽  
Direct Acting Antiviral ◽  
Genotype 1B ◽  
Direct Acting ◽  
End Stage

Background & Aims: Literature data suggest that HCV genotype-1b is present in 93-99% of the Romanian patients infected with hepatitis C virus (HCV). We present the genotyping tests recently performed on patients with HCV and advanced fibrosis eligible for the Direct-Acting Antiviral (DAA) therapy, as well as the prevalence of these cases across Romania.Methods: The genotyping method was performed on 7,421 HCV patients with advanced fibrosis. The detection method was automatic real time PCR platform M2000 (Abbott). Every subject was introduced into a database including age, sex, county and address.Results: Genotype 1b was almost exclusively present: 7,392/7,421 (99.6%). Genotype 1b patients were 19.6% from Bucharest, 49% were males, with a median age of 60 years. Genotype non-1b was encountered in 29/7,421 subjects (0.4%), 62% were males, 69% from Bucharest and the median age was 52 years. Most of the subjects (75%) were in the 6th and 7th age decade. The prevalence of these cases varied significantly across Romanian counties: the highest was in Bucharest (61.3/105), Bihor (47/105), Iasi (46/105) and Constanța (43/105), and the lowest in Ilfov (2.8/105), Harghita (3.7/105), Covasna (5.4/105) and Maramureș (8.8/105) (p<0.001).Conclusions: Genotype 1b is encountered in 99.6% of patients with chronic hepatitis C and advanced fibrosis from Romania. The presence of genotypes non-1b is more common in Bucharest, in males and at a younger age. There are significant differences regarding the distribution of these cases across Romania: the highest rates are in Bucharest, Bihor, Iasi and Constanta.Abbreviations: BMI: body mass index; DAA: direct-acting antiviral agent; GT: genotype; HBV: hepatitis B virus; HCC: hepatocellular carcinoma; HCV: hepatitis C virus; IDU: intravenous drug users; MELD: model for end stage liver disease; NASH: non-alcoholic steatohepatitis; SVR; sustained virologic response.

scholarly journals Incidence and Impact of Persistent Viremia on SVR Rates in Patients Receiving Direct-Acting Antiviral Therapy

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Alicia B Carver ◽  
Autumn D Zuckerman ◽  
Joshua DeClercq ◽  
Leena Choi ◽  
Cody A Chastain
Keyword(s):  
Antiviral Therapy ◽  
Real World ◽  
Sustained Virologic Response ◽  
Response Rates ◽  
Virologic Response ◽  
Direct Acting Antiviral ◽  
Rapid Virologic Response ◽  
Persistent Viremia ◽  
Direct Acting ◽  
High Sustained Virologic Response

Abstract Rates of persistent viremia (PV) while on direct-acting antiviral therapy were low (5.7%) in a real-world cohort of 983 patients. High sustained virologic response rates were achieved both in patients with PV (92.9%) and those with rapid virologic response (96.5%), without significant differences.

scholarly journals Direct-Acting Antivirals and Organ Transplantation: Is There Anything We Can’t Do?

2020 ◽  
Vol 222 (Supplement_9) ◽  
pp. S794-S801
Author(s):  
Matthew R Kappus ◽  
Cameron R Wolfe ◽  
Andrew J Muir
Keyword(s):  
Organ Transplantation ◽  
The United States ◽  
Virologic Response ◽  
Hcv Infection ◽  
Solid Organ ◽  
Direct Acting Antiviral ◽  
Transplant Candidates ◽  
Direct Acting ◽  
High Sustained Virologic Response ◽  
Waitlist Mortality

Abstract The opioid epidemic has resulted in an increase in organ donors with hepatitis C virus (HCV) infection in the United States. With the development of direct-acting antiviral regimens that offer high sustained virologic response rates even in the setting of immunosuppression after transplantation, these HCV-viremic organs are now being offered to transplant candidates with or without preexisting HCV infection. Strategies for HCV treatment with HCV-viremic organs have included delayed and preemptive approaches. This review will discuss key studies in the different solid organ transplants, recent reports of adverse events, and ethical and regulatory considerations. The efficacy of current HCV therapies has created this important opportunity to improve survival for patients with end-organ failure through greater access to organ transplantation and decreased waitlist mortality rate.

DI-062 Sustained virologic response rates of new direct acting antiviral agents for HCV

2016 ◽  
Vol 23 (Suppl 1) ◽  
pp. A145.2-A146
Author(s):  
C Caballero Requejo ◽  
M Onteniente Candela ◽  
JJ Franco Miguel ◽  
M Garcia Coronel ◽  
A Trujillano Ruiz ◽  
...  
Keyword(s):  
Sustained Virologic Response ◽  
Antiviral Agents ◽  
Response Rates ◽  
Virologic Response ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Direct Acting Antiviral Agents
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