CLINICAL TRIALS PROFILE FOR OMBITASVIR; PARITAPREVIR; RITONAVIR

All Clinical Trials for Ombitasvir; Paritaprevir; Ritonavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01458535 ↗	A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2011-09-01	The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
NCT01672983 ↗	A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2012-07-01	This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).
NCT01674725 ↗	A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2012-08-01	The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
NCT01685203 ↗	A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2012-08-01	The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.
NCT01704755 ↗	A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compens	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2012-10-01	The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.
NCT01767116 ↗	A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2012-12-01	The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

Clinical Trial Conditions for Ombitasvir; Paritaprevir; Ritonavir

Condition Name

Condition Name for Ombitasvir; Paritaprevir; Ritonavir
Intervention	Trials
Chronic Hepatitis C Infection	12
Chronic Hepatitis C	9
Hepatitis C Virus	6
Hepatitis C	4

Condition MeSH

Condition MeSH for Ombitasvir; Paritaprevir; Ritonavir
Intervention	Trials
Hepatitis C	37
Hepatitis	37
Hepatitis A	35
Hepatitis C, Chronic	32

Clinical Trial Locations for Ombitasvir; Paritaprevir; Ritonavir

Trials by Country

Trials by Country for Ombitasvir; Paritaprevir; Ritonavir
Location	Trials
United States	99
Australia	8
Spain	6
Canada	6
United Kingdom	6

Trials by US State

Trials by US State for Ombitasvir; Paritaprevir; Ritonavir
Location	Trials
Texas	8
North Carolina	8
Florida	8
California	8
New York	7

Clinical Trial Progress for Ombitasvir; Paritaprevir; Ritonavir

Clinical Trial Phase

Clinical Trial Phase for Ombitasvir; Paritaprevir; Ritonavir
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	20
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Ombitasvir; Paritaprevir; Ritonavir
Clinical Trial Phase	Trials
Completed	33
Unknown status	3
Terminated	2

Clinical Trial Sponsors for Ombitasvir; Paritaprevir; Ritonavir

Sponsor Name

Sponsor Name for Ombitasvir; Paritaprevir; Ritonavir
Sponsor	Trials
AbbVie	25
AbbVie (prior sponsor, Abbott)	6
Assiut University	3

Sponsor Type

Sponsor Type for Ombitasvir; Paritaprevir; Ritonavir
Sponsor	Trials
Industry	31
Other	17
NIH	1

Ombitasvir, Paritaprevir, and Ritonavir: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Ombitasvir, Paritaprevir, and Ritonavir

Ombitasvir, paritaprevir, and ritonavir, often combined in treatments like Viekira Pak and Technivie, are direct-acting antivirals (DAAs) that have revolutionized the treatment of chronic hepatitis C virus (HCV) infection. Here, we will delve into the clinical trials, market analysis, and future projections for these medications.

Mechanism of Action

Ombitasvir

Ombitasvir is an NS5A inhibitor, which targets the non-structural protein 5A of the HCV virus, crucial for viral replication and assembly[2][3].

Paritaprevir

Paritaprevir is an NS3/4A protease inhibitor, disrupting the viral protease necessary for the processing of HCV polyprotein[2][3].

Ritonavir

Ritonavir, although not active against HCV, acts as a pharmacokinetic enhancer by inhibiting the CYP3A enzyme, thereby increasing the plasma concentrations of paritaprevir[2][3].

Clinical Trials

Viekira Pak Trials

Viekira Pak, which includes ombitasvir, paritaprevir, ritonavir, and dasabuvir, was evaluated in six randomized, multicenter clinical trials involving 2,308 subjects with genotype 1 chronic HCV infection. These trials, such as SAPPHIRE-I, SAPPHIRE-II, and PEARL-IV, demonstrated high sustained virologic response rates (SVR12) of 96% to 97% for patients without cirrhosis[1].

Technivie Trials

Technivie, a combination of ombitasvir, paritaprevir, and ritonavir, was approved based on the results of the Pearl-I Phase II clinical trial. This trial showed a 100% SVR12 rate for treatment-naive patients with genotype 4 HCV infection without cirrhosis when treated with Technivie and ribavirin. For treatment-experienced patients, the SVR12 rate was also 100% when ribavirin was included[3].

Efficacy and Safety

Efficacy

The clinical trials have consistently shown high efficacy rates for these treatments. For genotype 1 HCV, Viekira Pak achieved SVR12 rates of 96% to 97% in various trials. For genotype 4 HCV, Technivie achieved a 100% SVR12 rate in both treatment-naive and treatment-experienced patients when combined with ribavirin[1][3].

Safety

Common adverse events reported in these trials include asthenia (weakness), fatigue, nausea, and insomnia. However, the overall safety profile has been favorable, with these side effects generally being mild to moderate[3].

Market Analysis

Cost-Effectiveness

Studies have shown that the combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir (with or without ribavirin) is cost-effective compared to traditional treatments involving pegylated interferon (PegIFN) and ribavirin. The incremental cost-effectiveness ratios were significantly lower, indicating better value for money in terms of quality-adjusted life-years (QALYs)[5].

Market Competition

The HCV treatment market is highly competitive, with several DAAs available. However, the combination of ombitasvir, paritaprevir, and ritonavir remains a strong contender due to its high efficacy rates and favorable safety profile. Other treatments like sofosbuvir/velpatasvir (Epclusa) and sofosbuvir/ledipasvir (Harvoni) are also popular, but the specific genotype and patient profile can influence the choice of treatment[1].

Projections and Future Outlook

Treatment Landscape

The HCV treatment landscape is expected to continue evolving with the development of new DAAs and combination therapies. However, ombitasvir, paritaprevir, and ritonavir are likely to remain significant players due to their established efficacy and safety profiles.

Global Access

Efforts to increase global access to these treatments are ongoing. This includes initiatives to reduce costs and improve availability in low- and middle-income countries, which are disproportionately affected by HCV.

Emerging Genotypes

As new genotypes of HCV emerge or become more prevalent, the adaptability of these treatments will be crucial. Current data suggest that ombitasvir and paritaprevir are effective against genotype 1 and 4, but ongoing research will be necessary to address other genotypes[2][3].

Key Takeaways

• High Efficacy Rates: Clinical trials have demonstrated high SVR12 rates for ombitasvir, paritaprevir, and ritonavir in treating genotype 1 and 4 HCV infections.
• Cost-Effectiveness: These treatments are cost-effective compared to traditional PegIFN/RBV regimens.
• Safety Profile: The safety profile is generally favorable, with common side effects being mild to moderate.
• Market Competition: The treatments face competition from other DAAs but remain strong contenders due to their efficacy and safety.
• Future Outlook: The treatments are expected to remain significant in the evolving HCV treatment landscape, with ongoing efforts to improve global access.

FAQs

What are the active ingredients in Viekira Pak and Technivie?

Viekira Pak includes ombitasvir, paritaprevir, ritonavir, and dasabuvir. Technivie includes ombitasvir, paritaprevir, and ritonavir[1][3].

What are the common side effects of these treatments?

Common side effects include asthenia (weakness), fatigue, nausea, and insomnia[3].

Are these treatments cost-effective?

Yes, studies have shown that these treatments are cost-effective compared to traditional PegIFN/RBV regimens[5].

Which genotypes of HCV are these treatments effective against?

These treatments are effective against genotype 1 and 4 HCV infections[1][3].

How long is the typical treatment duration?

The typical treatment duration is 12 weeks, often in combination with ribavirin[1][3].

Sources

1. Blue Cross and Blue Shield of Louisiana. "Treatment of Hepatitis C with ombitasvir, paritaprevir, ritonavir, and dasabuvir (Viekira Pak™)".
2. Australian Government Department of Health and Aged Care. "Australian public assessment for paritaprevir / ritonavir / ombitasvir".
3. Clinical Trials Arena. "Technivie (Ombitasvir, Paritaprevir, Ritonavir) for the Treatment of Genotype 4 Chronic Hepatitis C".
4. PharmGKB. "Annotation of FDA Label for ombitasvir / paritaprevir / ritonavir and dasabuvir".
5. PubMed. "Economic evaluation of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin for chronic genotype 1 hepatitis C virus infection".