Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie - LARVOL DELTA

The Impact of Organic Anion-Transporting Polypeptide (OATP) Variants on the Side Effects of Direct-Acting Antivirals in Hepatitis C Patients. (PubMed, Cureus) - "Ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir ± dasabuvir and 162 control individuals without hepatitis C. Treatment-related side effects were recorded. We found a significant difference between the patient and control groups in terms of the haplotype ratios of c.388A>G and c.521T>C (p = 0.036). Conclusions We found a significant relationship between the c.334T>G variant in OATP1B3 and DAA-related side effects in hepatitis C patients."

Adverse events • Journal • Dermatology • Fatigue • Hepatitis C • Infectious Disease • Inflammation • Pruritus

HCV cure with direct‐acting antivirals in HIV/HCV coinfected patients belonging to key populations (HIV-Glasgow 2024) - "The availability of DAAs varied during the years: ombitasvir/paritaprevir/ritonavir (4.1%), grazoprevir/elbasvir (14.0%), sofosbuvir/ledipasvir (34.7%), sofosbuvir/velpatasvir (47.1%), sofosbuvir/velpatasvir/voxilaprevir (4.9%). DAA treatment success rate in HIV/HCV coinfected patients from key population was high and comparable to those monoinfected. The SVR rates were similar in PLH infected by sexual mode or in PWIDs, irrespective of the CD4 cell count or HIV-VL. Elimination of HCV requires a targeted scale-up of DAA treatment and behavioural interventions in particular among high-risk populations."

Clinical • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir in Treating HCV Genotypes 1 and 4 in Patients with Advanced Chronic Kidney Disease. (PubMed, J Pharm Bioallied Sci) - "The treatment was well-tolerated, with two non-treatment-related deaths reported. The findings suggest that a 12-week regimen of OBV/PTV/r±DSV is highly effective and safe for GT1 and GT4 patients with advanced CKD, regardless of baseline characteristics."

Journal • Metastases • Chronic Kidney Disease • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

Programmed cell death-1 is involved with peripheral blood immune cell profiles in patients with hepatitis C virus antiviral therapy. (PubMed, PLoS One) - "In this study, we examined immune cell profiles in peripheral blood before and after ombitasvir/paritaprevir/ritonavir treatment and screened for genes that could be used to predict the therapeutic effects of DAAs...Therefore, we searched for genes associated with PD-1+ eTregs and CD8+ T cells that were significantly different between the SVR and non-SVR groups and found that T-box transcription factor 21 was associated with the non-SVR state. These results indicate that PD-1-related signaling pathways are associated with a non-SVR mechanism after DAAs treatment separate from mutation-related drug resistance."

Immune cell • IO biomarker • Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CD8 • PD-1 • TBX21 • TCF21

High efficacy of interferon-free therapy for acute hepatitis C in China (APASL 2024) - "According to patients' characteristics, 76 patients started treatment in the first four weeks (76/129, 58.91%), 27 patients started treatment between four and eight weeks (27/129, 20.93%), and 26 patients started treatment between eight and thirty-six weeks (26/129, 20.15%); following 15%, the following DAA regimens were prescribed: daclatasvir/yasunaprevir (6.2%; 8/129), sofosbuvir/radipavir (3.1%; 4/129), ombitasvir/paritaprevir/ritonavir (16.2%; 21/129), grazoprevir/elbasvir (59.6%; 77/129) and sofosbuvir/velpatasvir (14.7%; 19/129). Interferon-free DAA regimens can achieve 100% SVR12 in AHC patients with a favorable safety profile if treatment durations similar to CHC are used."

Clinical • Anorexia • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Experience with direct-acting antivirals in genotype 1-5 infected chronic hepatitis C patients in Turkey. (PubMed, Ann Saudi Med) - "Retrospective, single-center."

Journal • Fibrosis • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Oncology • Solid Tumor • Transplantation

MHH-HCV-NPM-Neuropsychiatric Manifestations of HCV-infection During and After Treatment With OBV/PTV/r and DSV (clinicaltrials.gov) - P4 | N=5 | Terminated | Sponsor: Hannover Medical School | N=30 ➔ 5 | Unknown status ➔ Terminated; The recruitment was stopped prematurely by the sponsor in accordance with the principal investigator because of the difficulties to recruit patients and to achieve the planned numbers of patients within a reasonable time frame.

Enrollment change • Trial termination • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Psychiatry

"دكتور، ليه viekirax اختفى؟ هل كان عليه مشاكل او اضرار جانبية ؟" (@arkidenyproject)

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study. (PubMed, Ther Innov Regul Sci) - "The highest severity index and seriousness were reported with SOF/RBV regimen. A significant association was found for OBV/PTV/r with renal impairment and anaemia although being the superior regimen in terms of efficacy. The study findings call for further population-based studies for clinical validation."

Adverse events • Journal • Fibrosis • Hematological Disorders • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Pain • Renal Disease

Global Pricing Trends of Hepatitis C Medications (ISPOR 2023) - "Price decreases for each individual medication ranged from 15% (sofosbuvir|velpatasvir|voxilaprevir) to 79% (dasabuvir|ombitasvir|paritaprevir|ritonavir). Overall trends in price reductions of Hepatitis C medications were significantly associated with greater numbers of manufacturers. Ensuring adequate competition across all markets may be important to ensure Hepatitis C medications are affordable and accessible to more patients. *ARGENTINA|AUSTRALIA|AUSTRIA|BANGLADESH|BELARUS|BELGIUM|BOSNIA|BRAZIL|BULGARIA|CANADA|CHILE|CHINA|COLOMBIA|CROATIA|CZECH REPUBLIC|EGYPT|ESTONIA|FINLAND|FRANCE|FRENCH WEST AFR|GERMANY|GREECE|HONG KONG|HUNGARY|INDIA|INDONESIA|IRELAND|ITALY|JAPAN|KAZAKHSTAN|KOREA|LATVIA|LEBANON|LITHUANIA|MALAYSIA|MEXICO|MOROCCO|NETHERLANDS|NEW ZEALAND|NORWAY|PAKISTAN|PERU|PHILIPPINES|POLAND|PORTUGAL|PUERTO RICO|ROMANIA|RUSSIA|SAUDI ARABIA|SERBIA|SINGAPORE|SLOVAKIA|SLOVENIA|SPAIN|SWEDEN|SWITZERLAND|TAIWAN|THAILAND|TUNISIA|TURKEY|UAE|UK|URUGUAY|US|VIETNAM"

Clinical • Pricing • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Long-term safety and efficacy results in hepatitis C virus genotype 1-infected patients receiving ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin in the TOPAZ-I and TOPAZ-II trials (EASL-ILC 2019) - "A high proportion of patients who achieved SVR with 3-DAA ± RBV in the TOPAZ studies showed long-term sustainability of SVR, with improvements in liver disease markers including FIB-4, METAVIR, CP scores, and platelet counts, and a low frequency of clinical outcomes related to long-term progression of liver disease. No new safety signals were detected.Table1: Clinical outcomesTOPAZ-I and II (N = 2211)n (%)All cause death26 (1.2)Liver related death1 ( < 0.1)Hepatic decompensation Cirrhotic patients8 (0.4)Liver transplantation Cirrhotic patients2 ( < 0.1)Hepatocellular Carcinoma (HCC)12 (0.5) Fibrosis stage (F0-F1), n3 F34 F45 Composite of any clinical outcomes42 (1.9)"

Clinical • Fibrosis • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor • Transplantation

Efficacy and safety of ombitasvir/paritaprevir/ritonavir-based therapy in HCV patients with chronic kidney disease. (PubMed, Arab J Gastroenterol) - "Ombitasvir/paritaprevir/ritonavir-based therapy in chronic HCV patients with CKD is highly effective, with minimal side effects despite ribavirin-induced anemia."

Journal • Chronic Kidney Disease • Hematological Disorders • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

Effectiveness and safety of generic and brand direct acting antivirals for treatment of chronic hepatitis C. (PubMed, World J Clin Cases) - "Generic and brand DAAs demonstrate comparable effectiveness in the treatment of chronic hepatitis C patients. Both are safe and equally effective in improving biochemical markers of hepatic inflammation."

Journal • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation

Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients. (PubMed, World J Gastroenterol) - "We documented very high effectiveness and a good safety profile across all DAA regimens. Positive predictors of SVR were female sex, absence of decompensated cirrhosis at baseline and higher platelet count while HIV coinfection reduced the effectiveness."

Journal • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation

Effects of a ritonavir-containing regimen on the pharmacokinetics of sirolimus or everolimus in healthy adult subjects. (PubMed, Pharmacol Res Perspect) - "In Period 2, multiple doses of the 3D regimen (ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily and dasabuvir 250 mg twice daily) were administered for 34 or 28 days, with a single dose of sirolimus 0.5 mg or everolimus 0.75 mg co-administered on Day 15. There were no major safety or tolerability issues in this study. The ritonavir-containing 3D regimen resulted in a significant increase in sirolimus or everolimus exposure, consistent with the known strong inhibitory effect of ritonavir on CYP3A requiring dose and/or frequency modification when co-administered with each other."

Journal • PK/PD data • Hepatology • Infectious Disease • Inflammation • CYP3A4

The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia. (PubMed, Saudi Pharm J) - "All patients with HCV treated with either ledipasvir plus sofosbuvir (LDS/SOF) ± ribavarin (RBV) or ombitasvir-paritaprevir-ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± RBV were included...Medications were well tolerated with minimal side effects, including vomiting, nausea, and weakness. DAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Is Enhancing Health-Related Quality of Life Correlated to Direct-Acting Antivirals Adherence in Chronic Hepatitis C Virus Patients? A Romanian Prospective Cohort Study (ISPOR-EU 2022) - " All patients with chronic HCV who received DAAs treatment (dasabuvir/ombitasvir/paritaprevir/ritonavir, Group 1, or ledipasvir/sofosbuvir, Group 2) at the Gastroenterology Department from University County Hospital of Craiova, Romania, in the period May 2020 – June 2021, were included. Our study reveals a significant increase of HRQoL after DAAs treatment also regarding some dimensions (sleeping, excretion, usual activities, mentality, discomfort, depression, distress, vitality, sexual activity). Using HCV-AD10, we were able to find high DAAs adherence with no differences between the type of treatment. Enhancing depression and distress were the only factors that increased medication adherence."

Clinical • HEOR • CNS Disorders • Depression • Fibrosis • Gastroenterology • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Psychiatry

Safety and Efficacy of Direct-acting Antiviral Therapies for Chronic HCV Infection in Hemodialysis Patients. (PubMed, In Vivo) - "Oral antiviral therapy with ombitasvir/paritaprevir/ritonavir and dasabuvir can be safely used in hemodialysis patients, with similar response rates compared to the general population."

Journal • Chronic Kidney Disease • Diabetic Nephropathy • Fatigue • Fibrosis • Hematological Disorders • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Nephrology • Pain • Renal Disease

Three regimens for re-treatment failure of Sofosbuvir-based therapy for chronic hepatitis-C genotype-4: a cohort study. (PubMed, Rev Inst Med Trop Sao Paulo) - "We included patients with CHC who did not achieve SVR after the complete course of Sofosbuvir/Daclatasvir±Ribavirin (SOF/DAC±RBV)...Group 3 (287 patients) received SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV) over 12-weeks...The three studied retreatment regimens can be used for DAAs treatment-experienced patients considering availability. The SOF/VEL/VOX combination had the least adverse events."

Journal • Observational data • Fibrosis • Gastroenterology • Hematological Disorders • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Liver Failure • Thrombocytopenia

Five-years follow-up of cured HCV patients with or without cirrhosis under real-world interferon-free therapy (EASL-ILC 2022) - " A total of 192 patients originally infected with HCV genotype 1 or 4 were analyzed five years after treatment with ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin. Despite the successful treatment of HCV infection 5 years after its completion, patients with cirrhosis are still at risk of developing liver cancer. This justifies screening for HCV, allowing therapy before the development of liver cirrhosis."

Clinical • Real-world evidence • Fibrosis • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Inflammation • Liver Cancer • Liver Cirrhosis • Oncology • Solid Tumor

Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic Review. (PubMed, Front Public Health) - "Eight out of 13 studies that compared EBR/GZR vs. other direct antiviral agents suggested that EBR/GZR was generally more cost-effective or dominant than daclatasvir/asunaprevir (DCV/ASV), sofosbuvir/velpatasvir (SOF/VEL), ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir (3D) but not more cost-effective than glecaprevir/pibrentasvir (GLE/PIB). EBR/GZR for CHC genotype 1 might be cost-effective or dominant compared with PegIFN/RBV and other direct antiviral agents (SOF/VEL, 3D, DCV/ASV, LDF/SOF) or non-therapy. However, under certain assumptions, EBR/GZR was not a cost-effective alternative for CHC patients vs. GLE/PIB."

HEOR • Review • Chronic Kidney Disease • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

Risk factors for developing hepatocellular carcinoma in patients treated with direct-acting antivirals. (PubMed, Rev Gastroenterol Mex (Engl Ed)) - "The risk factors for developing HCC were the presence of cirrhosis of the liver, Child-Pugh class B liver function, esophageal and/or gastric varices, and genotype 1b."

Journal • Fibrosis • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Obesity • Oncology • Solid Tumor • AFP

hsa-miR-17-5p: A Possible Predictor of Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir ± Ribavirin Therapy Efficacy in Hepatitis C Infection. (PubMed, Curr Microbiol) - "Moreover, a significant difference was found between the mRNA levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and HCV RNA pre-and post-treatment (P < 0.05). Further, miR-17-5p expression correlated with both ALT and AST mRNA levels post-treatment (P."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation • MIR17 • MIR223

Combined Use of Calcium-channel Blockers With Ombitasvir/Paritaprevir/Ritonavir Exacerbates Peripheral Edema in Elderly Japanese Patients. (PubMed, Anticancer Res) - "The use of OPR significantly increased the plasma concentration of amlodipine. Peripheral edema in patients treated with OPR and CCBs, although tolerable, should be closely monitored."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CYP3A4

TREATMENT WITH SOF/VEL/VOX IN HIV/HCV-COINFECTED PATIENTS PREVIOUSLY EXPOSED TO DAAs (CROI 2022) - "Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) is a pan-genotypic direct active antiviral (DAA) regimen approved for patients who have previously failed anti-HCV treatment with other DAAs...The type of previous regimens included sofosbuvir/ledipasvir in 50% patients, ombitasvir/paritaprevir/ritonavir plus dasabuvir in 9.4%, sofosbuvir plus daclatasvir in 9.4%, elbasvir/grazoprevir in 9.4%, glecaprevir/pibrentasvir in 9.4% and 13.4% other regimens...Liver cirrhosis and genotype did not influence treatment response (SVR by ITT 90% for cirrhosis and 85.8% for G3). Our findings suggest that SOF/VEL/VOX is a highly effective regimen for treatment of coinfected patients previously failing to DAA regimens, across all genotypes and in the presence of cirrhosis."

Clinical • Fibrosis • Gastroenterology • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Liver Cirrhosis