TAG’s Pipeline Report

Pipeline Report
Treatment Action Group provides updates on treatments for HIV, HCV & TB
by Hank Trout

Treatment Action Group (TAG) has announced the release of the first sections of their 2019 Pipeline Report. This annual report reviews the research and development of innovations for diagnosing, preventing, treating, and curing HIV, hepatitis C virus (HCV), and tuberculosis (TB). Additional updates, including on TB developments, will be added in the next few months.

Interested parties can now read the Pipeline Report 2019 updates online in easily downloadable PDFs on the following subjects:

Antiretroviral Therapy by Richard Jefferys. This report summarizes news on the antiretroviral front, including the announcement by ViiV Healthcare that they have applied for US FDA approval of the first long-acting injectable combination for monthly injection. The injectable consists of two drugs, Viiv’s cabotegravir, an integrase inhibitor, and rilpivirine, Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI). ViiV is seeking approval of the injectable for use in adults who have a suppressed viral load and aren’t resistant to either of the two drugs.

HIV Vaccines, Passive Immunization, and Antibody Gene Transfer Pipeline by Richard Jefferys. This report reviews news in the search for an HIV vaccine, including the prime-boost approach being developed by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. A large Phase III efficacy trial—MOSAICO—is due to start recruiting imminently, with a plan to enroll 3,800 cisgender men and transgender individuals who have sex with cisgender men and/or transgender individuals. Clinical trials will include the United States, Argentina, Brazil, Italy, Mexico, Peru, Poland, and Spain. A variety of vaccine candidates remain in something of a holding pattern in middle-phase.

Research Toward a Cure and Immune-Based Therapies Pipeline by Richard Jefferys. “So far,” the report states, “there have been no major therapeutic breakthroughs that would suggest a broadly efficacious curative approach is on the horizon. But there has been progress on several fronts.” After reviewing the cases of Timothy Ray Brown, the only person in the world thus far considered “cured” of HIV, and of the two people who may have been cured under similarly challenging circumstances were described in March at CROI (Conference on Retroviruses and Opportunistic Infections). It remains unclear how much of value can be garnered from those cases that might contribute to developing broadly applicable cures. So far, there have been no major breakthroughs that indicate a broadly efficacious curative approach is imminent. But there has been progress on several fronts, including work being done at Johns Hopkins University, the University of California, San Francisco, and by TAG itself.

HCV Diagnostics by Bryn Gay. This report begins with the rather somber assessment that, “there is unfinished business to remove the complicated, interrelated barriers to HCV testing. The significant progress that has been made to increase treatment and linkage to care among people with hepatitis C will be hampered if we do not invest in outreach, prevention, and point-of-care (POC) testing services, particularly for overlooked and under-served communities, including people who inject drugs. Meeting global diagnosis targets determines whether we meet the other elimination targets.” Because of the lack of outreach, the medical community is leaving the vast majority of people behind, undiagnosed and untreated. There have been major gaps in testing, treatment, and harm reduction coverage, except in a handful of countries. In 2017, only 19% of the targeted 30% of people with HCV were diagnosed. High patient out-of-pocket costs, insufficient lab capacity, centralized testing services, limited trained staff, and stigma and discrimination experienced by people living with HIV/HCV are among myriad barriers to diagnoses. There is some hope, though, as more affordable, effective, easy-to-use, high quality, point-of-care diagnostics options are becoming available or are in the pipeline, which could further help with screening and testing.

HCV Treatment by Annette Gaudino. Under the heading “Waiting for Generics,” Ms. Gaudino asserts that “Sofosbuvir was approved in the United States as the first interferon-free curative treatment for HCV in December 2013. Yet in the years since, only 5.5 million of the 71 million people worldwide living with chronic HCV have been treated.” Multinational trade agreements, in particular as pursued by the United States Trade Representative, seek to strengthen patent monopolies. Another obstacle to universally curing HCV is the criminalization of drug use and the social stigma that attaches to drug users.

Interested readers may read the Pipeline 2019 reports at TAG’s website, www.treatmentactiongroup.org. TAG encourages parties to feel free to use and share these resources widely in their scientific, policy, and advocacy work.

Hank Trout, Senior Editor, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a forty-year resident of San Francisco, where he lives with his fiancé Rick. Follow him on Twitter @HankTroutWriter.