Safety and Efficacy of Ombitasvir, Paritaprevir With Ritonavir ± Dasabuvir With or Without Ribavirin in Patients With Human Immunodeficiency Virus-1 and Hepatitis C Virus Genotype 1 or Genotype 4 Coinfection: TURQUOISE-I Part 2

Rockstroh, Jürgen K.; Orkin, Chloe; Viani, Rolando M.; Wyles, David L.; Luetkemeyer, Anne F; Lazzarin, Adriano; Soto-Malave, Ruth; Nelson, Mark; Klinker, Hartwig; Rizzardini, Giuliano; Girard, Pierre‐Marie; Tural, Cristina; Shulman, Nancy S.; Mobashery, Niloufar; Hu, Yiran; Fredrick, Linda; Pilot‐Matias, Tami; Trinh, Roger; Gane, Edward

doi:10.1093/ofid/ofx154

Cited by 16 publications

(10 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Of note, from the 386 patients with HIV/HCV included in this study, only 20 did not achieve SVR12 (5.2%, 6 with missing data). Patients with HIV/HCV with or without cirrhosis treated with other DAAs have achieved high SVR12 rates, which shows that DAA regimens are effective and well tolerated by patients coinfected with HIV/HCV with or without cirrhosis, as previously reported [16, 31].…”

Section: Discussionsupporting

confidence: 78%

See 1 more Smart Citation

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain

et al. 2019

View full text Add to dashboard Cite

AimWe describe the effectiveness and safety of the interferon-free regimen ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) in a nationwide representative sample of the hepatitis C virus (HCV) monoinfected and human immunodeficiency virus-1/hepatitis C virus (HIV/HCV) coinfected population in Spain.Material and methodsData were collected from patients infected with HCV genotypes 1 or 4, with or without HIV-1 coinfection, treated with OBV/PTV/r ± DSV ± RBV at 61 Spanish sites within the initial implementation year of the first government-driven “National HCV plan.” Effectiveness was assessed by sustained virologic response at post-treatment week 12 (SVR12) and compared between monoinfected and coinfected patients using a non-inferiority margin of 5% and a 90% confidence interval (CI). Sociodemographic and clinical characteristics or patients and adverse events (AEs) were also recorded.ResultsOverall, 2,408 patients were included in the intention-to-treat analysis: 386 (16%) were patients with HIV/HCV. Patient selection reflected the real distribution of patients treated in each participating region in Spain. From the total population, 96.6% (95% CI, 95.8–97.3%) achieved SVR12. Noninferiority of SVR12 in coinfected patients was met, with a difference between monoinfected and coinfected patients of −2.2% (90% CI, −4.5% - 0.2%). Only genotype 4 was associated with non-response to OBV/PTV/r ± DSV ± RBV treatment (p<0.001) in the multivariate analysis. Overall, 286 patients (11.9%) presented AEs potentially related to OBV/PTV/r ± DSV, whereas 347 (29.0%) presented AEs potentially related to ribavirin and 61 (5.1%) interrupted ribavirin.ConclusionsOur results confirm that OBV/PTV/r ± DSV ± RBV is effective and generally well tolerated in a representative sample of the HCV monoinfected and HCV/HIV coinfected population in Spain within the experience of a national strategic plan to tackle HCV.

show abstract

Section: Discussionsupporting

confidence: 78%

“…Accordingly, they have become the new standard of care in patients with chronic HCV infection [10, 11]. The DAA combination of ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) has shown favorable efficacy and tolerability in clinical studies [12–16].…”

Section: Introductionmentioning

confidence: 99%

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Lower SVR rates may be expected in cirrhotic patients and particularly TE cirrhotic patients treated in routine clinical practice [13, 20]. However, our subgroup analysis of SVR12 rates for whether cirrhotic or non-cirrhotic, TN or TE patients were highly effective which were all over 96%.…”

Section: Discussionmentioning

confidence: 81%

Effectiveness of ombitasvir/paritaprevir/ritonavir, dasabuvir for HCV in HIV/HCV coinfected subjects: a comprehensive analysis

Huang

Fan

et al. 2019

Virol J

View full text Add to dashboard Cite

BackgroundData on the treatment of patients with hepatitis C virus (HCV)/human immunodeficiency virus (HIV) coinfection remains limited. A comprehensive analysis was performed to evaluate the efficacy and safety of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir(r) ± dasabuvir (DSV) ± ribavirin (RBV) for treatment in HCV/HIV coinfected patients.MethodsWe systematically searched and included studies that enrolled patients with HIV/HCV coinfection using the OBV/PTV/r ± DSV ± RBV regimens and reported sustained virological response after 12 weeks (SVR12) end-of-treatment. Heterogeneity of results was assessed and pooled SVR rates were computed with 95% confidence intervals (95%CI). Subgroup analysis and assessment of publication bias through Egger’s test were further performed.ResultsTen studies containing 1358 coinfected patients were included in this study. The pooled estimate of SVR12 was 96.3% (95%CI: 95.1–97.4). Subgroup analysis showed that pooled SVR12 rate was 96.2% (95% CI: 94.8–97.4) for patients with genotype (GT) 1 and 98.8% (95% CI: 95.1–100.0) for those with GT4. The SVR12 rates for the treatment-naïve (TN) and treatment-experienced (TE) patients were 96.8% (95% CI, 94.8–98.5) and 98.9% (95% CI, 96.4–100.0), respectively. Pooled SVR12 rate was 97.8(95%CI: 94.6–99.8) for patients with cirrhosis and 96.7% (95%CI: 95.3–97.8) without cirrhosis. The pooled incidence of any adverse events (AEs) and serious adverse events (SAEs) was 73.9% (95%CI: 38.1–97.6) and 2.7% (95%CI: 0.0–9.5). Publication bias did not exist in this study.ConclusionsThe comprehensive analysis showed high efficacy for the OBV/PTV/r ± DSV ± RBV regimen in patients coinfected with HIV and HCV, regardless of genotypes, history of treatment and the presence or absence of cirrhosis.Electronic supplementary materialThe online version of this article (10.1186/s12985-018-1114-4) contains supplementary material, which is available to authorized users.

show abstract

“…No report included background information on recruitment methods (e.g., flyer, bus ad, outreach in clinics) or sampling methodologies (e.g., consecutive patients); inquiries for supplemental information yielded one result. Testing intervals ranged from varied or not delineated in three studies [ 21 , 22 , 25 ] to a single testing time point in three studies [ 20 , 23 , 26 ]; only two studies delineated multiple testing time points over a significant follow-up period (2–6 years).…”

Section: Resultsmentioning

confidence: 99%

Hepatitis C Reinfection in People Who Inject Drugs in Resource-Limited Countries: A Systematic Review and Analysis

Muller

Vlahov

Akiyama

et al. 2020

IJERPH

View full text Add to dashboard Cite

Hepatitis C (HCV) is a global pandemic. The World Health Organization has developed a strategic plan for HCV elimination that focuses on low- and middle-income countries (LMICs) and high-risk populations, including people who inject drugs (PWID). While direct-acting antiviral (DAA) therapies are highly effective at eliminating HCV infections and have few side effects, medical professionals and policymakers remain concerned about the risk of reinfection among PWID. This study is a systematic review of research measuring the rate of HCV reinfection among PWID in LMICs and identifies additional areas for further research. A systematic search strategy was used to identify studies documenting HCV reinfection after sustained virologic response in PWID in LMICs. We refined results to include studies where at least 50% of participants had DAA treatment for primary HCV infection. Pooled reinfection rate was calculated across all studies. Seven studies met eligibility criteria. Most studies were conducted in six upper middle-income countries (Mexico, Romania, Russia, Taiwan, Georgi, and Brazil) and one lower middle-income country (Bangladesh) with a total of 7665 participants. No study included information from PWID in low-income countries. Sample sizes ranged from 200 to 3004 individuals, with demographic data missing for most participants. Four studies used deep gene sequencing, and reflex genotyping procedures to differentiate reinfection (infection by a different HCV genotype/subtype) from virologic relapse (infection by the same strain). The follow-up time of people cured from primary chronic HCV infection ranged from 12 weeks to 6.6 years. The pooled reinfection rate of all seven studies was 2.8 (range: 0.02 to 10.5) cases per 100 person-years (PY). In the five studies that differentiated relapse from reinfection, the incidence of reinfection was 1.0 per 100 PY. To date, research on reinfection rates among PWID in LMICs remains limited. Research focused on PWID in low-income countries is particularly needed to inform clinical decision making and evidence-based programs. While rates of reinfection among PWID who complete DAA treatment in upper and lower middle-income countries were similar or lower than rates observed in PWID in high-income countries, the rates were highly variable and factors may influence the accuracy of these measurements. This systematic review identifies several areas for continued research. Policies concerning access to HCV testing and treatment should be comprehensive and not place restrictions on PWID in these settings.

show abstract

Safety and Efficacy of Ombitasvir, Paritaprevir With Ritonavir ± Dasabuvir With or Without Ribavirin in Patients With Human Immunodeficiency Virus-1 and Hepatitis C Virus Genotype 1 or Genotype 4 Coinfection: TURQUOISE-I Part 2

Cited by 16 publications

References 19 publications

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain

Effectiveness of ombitasvir/paritaprevir/ritonavir, dasabuvir for HCV in HIV/HCV coinfected subjects: a comprehensive analysis

Hepatitis C Reinfection in People Who Inject Drugs in Resource-Limited Countries: A Systematic Review and Analysis

Contact Info

Product

Resources

About