Treatment Action Group (TAG) recently released their TAG 2010 Pipeline Report (.pdf – 1,700kb), an annual report that explores the progress and overall state of drug development in the fields of HIV, Tuberculosis, and Viral Hepatitis. The report covers the development of drugs, diagnostics, vaccines, immune-based therapies, and preventative technologies in development in each field.
Included in the report is a section on the global TB drug portfolio, and what follows are some highlights from the report as well as some notable recommendations offered to the field, based upon analysis of the overall research landscape.
Overview of the state of TB drug research and development:
- The current TB drug pipeline is most full and promising it has been in 50 years, with 10 drug candidates currently in clinical trials—a level unprecedented since the 1960s.
- The enthusiasm inspired by this recent progress must be balanced with a realistic acknowledgment that even with ten drugs in the pipeline—six of them novel—the global portfolio is not robust enough to achieve the World Health Organization’s (WHO’s) goal of halving global TB incidence from 1990 levels by 2015, nor the Stop TB Partnership’s target of having six new TB drugs approved by then.
- Companies may be underestimating the potential for profits from superior new drugs and treatment regimens that could improve cure rates and shorten treatment duration.
- Despite the fact that people with HIV, infants, and young children bear an undue burden of TB morbidity and mortality, they are often excluded from many clinical trials. As a result there is a dearth of age-specific data on the correct dosing of TB drugs in children, or how best to dose TB drugs and ARVs concurrently.
- Pregnant women are also consistently excluded from participation in TB clinical trials despite their high risk for TB morbidity and mortality.
Key advances in the field:
- The Tuberculosis Trials Consortium (TBTC) was recently reconfigured to include more international sites with increased capacity to conduct treatment trials for drug-resistant TB and enroll more HIV-positive volunteers and children into studies.
- In 2009, the U.S. National Institute of Allergies and Infectious Diseases (NIAID)—the largest public funder of TB research in the world—announced that TB would be integrated as one of the focal areas of its reconfigured HIV clinical trials network system, including the AIDS Clinical Trials Group, the HIV Vaccine Trials Network, and other sites. By broadening the scope of the NIAID-supported clinical trials infrastructure to include studies evaluating TB drugs for both monoinfection and HIV coinfection, the TB treatment research field will in short order almost double its capacity to conduct clinical trials in high- and medium-TB-burden settings among geographically and demographically.
- In March 2010, the Critical Path to TB Drug Regimens (CPTR) Initiative was launched to accelerate the evaluation and regulatory approval of novel TB treatment regimens. The initiative is a collaborative effort of public- and private-sector stakeholders—including the FDA, the Critical Path Institute, the Alliance for Global TB Drug Development (TB Alliance), the Bill and Melinda Gates Foundation, and several pharmaceutical companies including Anacor, AstraZeneca, Bayer, Novartis, Otsuka, Pfizer, Sanofi-Aventis, Sequella, and Tibotec/Johnson & Johnson—to identify more efficient ways to study TB drugs in combination to expedite regimen change rather than introducing TB drugs sequentially. The move to regimen development is a paradigm shift for the field.
Recommendations for the field
- Funding for TB drug research and development is wholly insufficient to address the gaps to support even current efforts. The field needs more funders to invest in TB research including basic science, which is the foundation for the development of all new tools. More funds are necessary to ensure that there are sufficient resources to conduct phase III and IV studies of the compounds already in the pipeline and support the development of those in discovery and preclinical studies.
- Pregnant women, children, and people with HIV must be included in clinical trials of new TB drugs and regimens.
- Investment to build the capacity of activists to understand and advocate for research on new drugs and the uptake of these new tools is critical.
- Policy makers must think more innovatively about their national TB guidelines and be unafraid to challenge the status quo. Ministries of Finance need to ensure that national TB programs are adequately resourced and Ministries of Health must adopt new evidence-based treatment strategies quickly and consistently.
Click here to read the whole report. (The section on TB drugs begins on page 125 of the publication.)