CLINICAL TRIALS PROFILE FOR RIFAPENTINE

All Clinical Trials for Rifapentine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002192 ↗	Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.	Completed	Hoechst Marion Roussel	Phase 2	1969-12-31	To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
NCT00002192 ↗	Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.	Completed	Anderson Clinical Research	Phase 2	1969-12-31	To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
NCT00023335 ↗	TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis	Completed	US Department of Veterans Affairs	Phase 3	1995-04-01	Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.
NCT00023335 ↗	TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis	Completed	VA Office of Research and Development	Phase 3	1995-04-01	Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.

Clinical Trial Conditions for Rifapentine

Condition Name

Condition Name for Rifapentine
Intervention	Trials
Tuberculosis	27
Latent Tuberculosis	5
HIV	4
Tuberculosis, Pulmonary	4

Condition MeSH

Condition MeSH for Rifapentine
Intervention	Trials
Tuberculosis	51
Latent Tuberculosis	18
Infections	9
Tuberculosis, Pulmonary	9

Clinical Trial Locations for Rifapentine

Trials by Country

Trials by Country for Rifapentine
Location	Trials
United States	130
South Africa	24
Canada	18
Brazil	14
Thailand	8

Trials by US State

Trials by US State for Rifapentine
Location	Trials
Texas	13
New York	13
California	12
Maryland	11
Colorado	10

Clinical Trial Progress for Rifapentine

Clinical Trial Phase

Clinical Trial Phase for Rifapentine
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	19
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Rifapentine
Clinical Trial Phase	Trials
Completed	28
Not yet recruiting	12
Recruiting	11

Clinical Trial Sponsors for Rifapentine

Sponsor Name

Sponsor Name for Rifapentine
Sponsor	Trials
Centers for Disease Control and Prevention	14
Johns Hopkins University	10
National Institute of Allergy and Infectious Diseases (NIAID)	9

Sponsor Type

Sponsor Type for Rifapentine
Sponsor	Trials
Other	102
U.S. Fed	25
NIH	13

Rifapentine: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Rifapentine

Rifapentine, a potent antimycobacterial drug, has been a cornerstone in the treatment and prevention of tuberculosis (TB) for several decades. Recently, there have been significant advancements in its use, particularly in the context of latent TB infection (LTBI) and its application in pediatric populations.

Clinical Trials and Safety Studies

TBTC Study 35: A Breakthrough for Pediatric Use

A landmark study, TBTC Study 35, conducted by the Tuberculosis Trials Consortium (TBTC) at the U.S. Centers for Disease Control and Prevention, has provided critical insights into the use of rifapentine in children. This phase I/II clinical trial focused on the dose-finding and safety of rifapentine and isoniazid in children aged 0-12 years with latent TB infection, including both HIV-positive and HIV-negative children. The study confirmed the safety and tolerability of the 3HP regimen (rifapentine and isoniazid administered once a week for 12 weeks) in this demographic, which was previously lacking in clinical research. This advancement ensures better management of TB infection in children by adapting doses based on weight rather than age ranges[1].

PREVENT TB Study

The PREVENT TB study, conducted by the CDC-TBTC, compared a 12-week, once-weekly regimen of rifapentine plus isoniazid (3RPT/INH) with 9 months of self-administered daily isoniazid (9INH). The results showed a significantly higher completion rate of treatment in the 3RPT/INH group (81.2% vs 68.3%) and a lower incidence of TB disease. This study led to the FDA approval of Priftin® (rifapentine) in combination with isoniazid for LTBI treatment in patients two years of age and older[3].

Six Weeks of Daily Rifapentine Trial

A phase 3 clinical trial is currently underway to compare the safety and effectiveness of a 6-week regimen of daily rifapentine against the standard 12-16 weeks of rifamycin-based treatment for LTBI. This trial aims to determine if a shorter treatment duration can be as effective as the current standard, potentially improving adherence and outcomes[4].

Market Analysis and Projections

Market Size and Growth

The rifampin market, which includes rifapentine as a key component, was valued at USD 2.2 billion in 2023 and is projected to reach USD 3.2 billion by 2031, growing at a CAGR of 5.4%. This growth is driven by several factors, including the rising prevalence of TB, particularly in developing nations, and the increasing cases of multidrug-resistant infections[2].

Application Segments

The rifampin market is primarily segmented into two critical areas: TB treatment and leprosy treatment. TB treatment dominates this segment, with rifampin being a cornerstone in the multidrug regimen used to combat TB. The rise in TB cases globally, especially in developing countries, and the emergence of antibiotic-resistant strains further drive the demand for rifampin and related drugs like rifapentine[2].

Geographical Segmentation

The market is geographically segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America. The Asia-Pacific region exhibits the largest market potential due to the high burden of infectious diseases and increasing healthcare initiatives to combat TB. Countries like India and China are focusing on increasing access to essential medications, including rifapentine[2].

Price Reduction and Accessibility

Landmark Price Agreement

A significant price reduction for rifapentine has been achieved through a volume-based agreement between Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Sanofi. This agreement reduces the price of a three-month treatment course of rifapentine by nearly 70%, from approximately US$45 to US$15. This reduction will significantly broaden access to better preventive therapy for LTBI, especially in low- and middle-income countries[5].

Impact on Global Health

Expanded Access and Scale-Up

The reduced price of rifapentine is expected to transform the global fight against TB by making this lifesaving drug more affordable and accessible. Countries like South Africa are pioneering the scale-up of rifapentine-based TB preventive therapy, supported by domestic financing and international partners such as the Global Fund and PEPFAR. This initiative is projected to save thousands of lives and realize significant economic savings[5].

Future Outlook

Increasing Demand and Supply Security

The increased demand for rifapentine due to its expanded use and lower cost necessitates greater supply security. Efforts are underway to involve additional manufacturers to ensure a stable and competitive supply of rifapentine-containing regimens. This will be crucial in meeting the growing demand and ensuring that the benefits of this drug reach the widest possible population[5].

Key Takeaways

• Clinical Trials: Recent studies like TBTC Study 35 and the PREVENT TB study have established the safety and efficacy of rifapentine in various populations, including children.
• Market Growth: The rifampin market, which includes rifapentine, is projected to grow significantly due to the rising prevalence of TB and the need for effective treatments.
• Price Reduction: A landmark agreement has reduced the price of rifapentine, making it more accessible in low- and middle-income countries.
• Global Impact: The expanded access to rifapentine is expected to significantly improve TB prevention efforts globally.

FAQs

What is the significance of TBTC Study 35 for rifapentine use in children?

TBTC Study 35 is significant because it provides the first comprehensive data on the safety, tolerability, and appropriate dosing of rifapentine and isoniazid in children aged 0-12 years, including both HIV-positive and HIV-negative children.

How does the PREVENT TB study impact the use of rifapentine?

The PREVENT TB study demonstrated that a 12-week regimen of rifapentine plus isoniazid is as effective as, and has higher treatment completion rates than, the traditional 9-month daily isoniazid regimen, leading to FDA approval and updated treatment guidelines.

What is the impact of the price reduction agreement on rifapentine accessibility?

The price reduction agreement reduces the cost of a three-month treatment course of rifapentine by nearly 70%, making it significantly more affordable and accessible in low- and middle-income countries, thereby broadening access to better preventive therapy for LTBI.

Which regions are expected to drive the growth of the rifampin market?

The Asia-Pacific region is expected to drive the growth of the rifampin market due to the high burden of infectious diseases and increasing healthcare initiatives to combat TB in countries like India and China.

What are the future challenges in ensuring the supply of rifapentine?

Ensuring sufficient supply and competition in the rifapentine market is a future challenge. Efforts are underway to involve additional manufacturers to meet the growing demand and ensure stable supply chains.

Sources

1. Community Research Advisors Group, "Finally, Children of All Ages Can Benefit from 3HP to Prevent TB!"
2. Verified Market Research, "Rifampin Market Size, Share, Scope, Growth, Trends & Forecast"
3. Sanofi, "Sanofi Receives FDA Approval of Priftin® (rifapentine) Tablets for the Treatment of Latent Tuberculosis Infection"
4. George Washington University, "Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-Based Treatment"
5. Unitaid, "Landmark deal secures significant discount on price of medicine to prevent TB"