Two Standards of Care: Fact Sheet

TWO STANDARDS OF CARE: TOWARD TREATMENT EQUITY FOR PEOPLE LIVING WITH HIV/HCV CO-INFECTION FACTSHEET

We are in the middle of unprecedented drug development to treat hepatitis C, with many expecting a functional cure for the virus within the next decade. However, this news is not so bright for people who are co-infected with HIV/HCV, who always get access to treatment after it is available for people living with HCV alone.

There are two main reasons why access to new treatments is delayed for people living with HIV/HCV co-infection: 1. Clinical trials for new hepatitis C treatments delay inclusion 2. Health technology assessments, such as the of co-infected people for longer than necessary Common Drug Review (CDR), restrict access to treatment for co-infected people • Drug development is expensive ($500 million to $2 billion for each new medication), and co-infected people are harder to treat, therefore new treatments are first tested on mono-infected people • The Sitges Statement i recommends clinical trials for coinfected people begin directly after Phase 2Bii trials show a new medication is safe and effective, ensuring new medications do not have negative drug interactions with HIV treatments • Clinical trials for boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex), the first two direct-acting antivirals to treat genotype 1 hepatitis C as part of triple therapy, did not include people with co-infection until part-way through Phase 3 trials in mono-infected people • Clinical trials for sofosbuvir (Gilead) are much more in line with The Sitges Statement, conducting HIV drug-drug interaction studies before Phase 2 was completed and including co-infected people three months after Phase 3 trials for mono-infected people began • The delay for clinical trial completion in mono-infected people vs. co-infected people will be 4 years and 4 months for boceprevir, 3 years and 8 months for telaprevir, and 10 months for sofosbuvir

• The inclusion of co-infected people in clinical trials was delayed, thus the CDR refused to recommend boceprevir and telaprevir for these.

Initially, recommendations for boceprevir and telaprevir were in October 2011 and February 2012, respectively • In June 2013, the CDR changed its decision to recommend boceprevir and telaprevir for coinfected people, as long as it is prescribed by an experienced physician • In April 2013, Canadian co-infection treatment guidelines were presented at the CAHR Conference, recommending use of boceprevir or telaprevir as a part of triple therapy in co-infected people • The CDR was behind the evidence, unnecessarily preventing doctors from prescribing optimal therapy for their patients living with HIV/HCV co-infection

POLICY RECOMMENDATIONS Recommendation 1: Regulations and recommendations on hepatitis C drug development, coled between scientists, civil society groups and the pharmaceutical industry, must be developed, adopted and enforced by regulatory agencies (including Health Canada and the United States Food and Drug Administration).

Recommendation 2: The Government of Canada’s Panel for Research Ethics is encouraged to review the ethics of excluding people who are “harder to treat” and people who use drugs in the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, to identify these as “inappropriate exclusions,” and to develop pragmatic guidelines on including “harder to treat” people and people who use drugs in clinical trials.

Recommendation 3: The Canadian Agency for Drugs and Technology in Health (CADTH), in coalition with hepatitis C and HIV civil society groups, must develop Therapeutic Reviews outlining good treatment availability and prescription practices in the areas of hepatitis C, HIV and HIV/HCV co-infection.

Recommendation 4: Instead of recommending against using new hepatitis C medications among people living with HIV/HCV co-infection, the Canadian Drug Expert Committee (CDEC) is advised to issue guidance in accordance with the language used after boceprevir and telaprevir were reviewed: new medications may fulfill “unmet therapeutic need” and “the treatment of patients co-infected with HIV and HCV should be under the direction of a physician experienced in managing such patients.”

Recommendation 5: The CADTH is advised to explore expanding the CDR's equity focus, drawing on equity-oriented tools available through the World Health Organization’s Collaborating Center for Knowledge Translation and Health Technology Assessment in Health Equity.

To download the Two Standards of Care policy paper, please visit: http://www.ctac.ca/toolsforaccess/ hivhepatitis-co-infection

i

The Sitges Statement is a policy paper produced by the European AIDS Treatment Group (EATG)

ii

Phase 2 trials test safety and efficacy among the patients with the condition a new medication is intended to treat, comparing a standard of care placebo with the new treatment. These trials include between 100-300 people. Phase 3 trials occur if safety and efficacy was demonstrated during Phase 2 trials to demonstrate a new medication is effective amongst many more patients (between 1000-3000 people).