# Stop excluding people with a prior cancer, controlled HIV, or treated hepatitis

Source: https://onco.cc/ideas/idea-tr1-prior-cancer-hiv-hepatitis-inclusion/  
OnCo record `idea-tr1-prior-cancer-hiv-hepatitis-inclusion` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Having had another cancer years ago, or living with controlled HIV or treated hepatitis, still keeps patients out of trials for no scientific reason. Condition-specific rules, as FDA guidance recommended in 2020, would replace blanket bans and widen access in communities where these conditions are more common.

## Summary

Protocols would replace blanket exclusions with condition-specific rules: prior malignancy allowed unless it is likely to interfere with the endpoint; HIV allowed if on effective antiretrovirals with adequate CD4 count; hepatitis B and C allowed if suppressed or cured. The FDA issued a guidance to this effect in 2020; adoption is incomplete and monitoring of adoption is absent.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Trials adopting these criteria will increase enrolment of Black and Hispanic participants in the US and of participants in high-HIV-prevalence countries, with no detectable difference in efficacy estimates or serious adverse events among the newly eligible.
- Rationale: Cancer survivors are a growing population and often have the same disease biology; HIV on modern therapy does not alter most drug pharmacology or checkpoint-inhibitor safety in observational series; hepatitis exclusion is largely a legacy of hepatotoxicity concerns that can be handled by monitoring.
- Proposed test: Audit new industry phase 3 protocols each year for these exclusions, publish a scorecard, and compare outcomes of the newly eligible subgroup in trials that include them.
- Maturity: early-clinical
- Actor: industry

## Sources

- FDA: Eligibility Criteria: Patients with HIV, Hepatitis B or Hepatitis C: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-hiv-hepatitis-b-virus-or-hepatitis-c-virus

## Connected records

- institutions: [American Society of Clinical Oncology (ASCO)](https://onco.cc/institutions/asco/), [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- bottlenecks: [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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