PROVEN
*November 2017: FDA approval for adults and children with hemophilia A with factor VIll inhibitors.
†Number of people with hemophilia A treated with HEMLIBRA worldwide as of June 2025.
‡Number of people with hemophilia A treated with HEMLIBRA in the US as of August 2025.
ZERO IS POSSIBLE: A majority of people on HEMLIBRA had zero bleeds requiring treatment, regardless of their age, dosing option, or inhibitor status in the HAVEN 1-4 clinical trials§
PERCENTAGE OF PEOPLE WITH ZERO BLEEDS REQUIRING TREATMENT
HAVEN 1
ADULTS AND YOUNG ADULTS WITH FACTOR VIII INHIBITORS
of people taking HEMLIBRA ONCE A WEEK had 0 bleeds (22/35)
VS
of people taking bypassing agents to treat bleeds on-demand (no prophylaxis) had 0 bleeds (1/18)
HAVEN 2
CHILDREN WITH FACTOR VIII
INHIBITORS
of people taking HEMLIBRA ONCE A WEEK had 0 bleeds (50/65)
of people taking HEMLIBRA ONCE EVERY 2 WEEKS had 0 bleeds (7/10)
of people taking HEMLIBRA ONCE EVERY 4 WEEKS had 0 bleeds (6/10)
HAVEN 3
ADULTS AND YOUNG ADULTS WITHOUT FACTOR VIII INHIBITORS
of people taking HEMLIBRA ONCE A WEEK had 0 bleeds (20/36)
of people taking HEMLIBRA ONCE EVERY 2 WEEKS had 0 bleeds (21/35)
VS
of people taking factor VIII to treat bleeds on-demand (no prophylaxis) had 0 bleeds (0/18)
HAVEN 4
ADULTS AND YOUNG ADULTS WITH OR WITHOUT FACTOR VIII INHIBITORS
of people taking HEMLIBRA ONCE EVERY 4 WEEKS had 0 bleeds (23/41)
median annualized bleed rate for treated bleeds across all populations and dosing schedules studied in HAVEN 1-4.§II
Adults: 18 years or older. | Young adults (adolescents): 12 years to less than 18 years.
The average number of bleeds per year (ABR, annualized bleed rate)II
- HAVEN 1: once every week 2.9, no prophylaxis 23.3
- HAVEN 2: once every week 0.3, once every 2 weeks 0.2, once every 4 weeks 1.8
- HAVEN 3: once every week 1.5, once every 2 weeks 1.3, no prophylaxis 38.2
- HAVEN 4: once every 4 weeks 2.4
The most common side effects of HEMLIBRA include: injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain.
The median time on treatment for HAVEN 1: 29 weeks (once every week), 24 weeks (no prophylaxis); HAVEN 2: 58 weeks (once every week), 67 weeks (once every 2 weeks), 67 weeks (once every 4 weeks); HAVEN 3: 30 weeks (once every week), 31 weeks (once every 2 weeks), 24 weeks (no prophylaxis); HAVEN 4: 26 weeks (once every 4 weeks). A median is a numeric middle. That means that in a list of numbers, the median is the number in the middle.
Data from HAVEN 2 analysis are descriptive and therefore should be interpreted with caution.
§The need to treat was determined by the individual or the study physician.
IIABRs shown are for treated bleeds.
of people without inhibitors (HAVEN 3) chose to stay on for the long-term portion of the study. Data from long-term treatment and additional studies are shown below.
Consistent HEMLIBRA benefit was observed in a long-term study
Percentage of people who had zero bleeds that needed treatment in each 24-week period over 144 weeks in the pooled analysis of the HAVEN 1-4 studies
| WEEKS 1-24 | WEEKS 25-48 | WEEKS 49-72 | WEEKS 73-96 | WEEKS 97-120 | WEEKS 121-144 |
| 71% | 80% | 81% | 84% | 83% | 82% |
| 277/391 people | 300/374 people | 279/343 people | 237/283 people | 171/207 people | 140/170 people |
Data for each period should be looked at individually—not over time. This analysis was based on a descriptive study not designed to determine a definitive benefit.
- The average number of treated bleeds (ABR, annualized bleed rate) over the entire study was 1.4
- No new safety concerns were identified
- 381/399 people (96%) reported ≥1 side effect
- The most common treatment-related side effect was injection site reactions (27% of people)
- 94% of all injection site reactions (treatment-related or not) were mild and 84% occurred during the first 24 weeks
- 144 serious side effects occurred in 93 people
- 6 people had treatment-related serious side effects
- There were 3 events of thrombotic microangiopathies (TMAs) and 4 blood clots (thrombotic events)
- All 3 TMAs and 2 of the 4 blood clots occurred in people with inhibitors who were treated with a bypassing medicine, aPCC, in combination with HEMLIBRA. These events were previously reported in the HAVEN 1 trial
What is a pooled analysis?
Researchers combine data from several studies to summarize the overall results.
Why do groups differ in size?
When HEMLIBRA was approved by the FDA for people with and without FVIII inhibitors in November 2017 and October 2018, participants could choose to leave the long-term study, but still continue on HEMLIBRA. People who left the study (for any reason) are not included in the later intervals of the analysis.
of people had zero bleeds that needed treatment in each discrete 24-week period
Additional Clinical Trials of HEMLIBRA
HAVEN 6
People with mild or moderate hemophilia A without inhibitors (N=72)
HAVEN 7
Infants without inhibitors (N=55)
PHASE 1/2 STUDY
Adults and adolescents with or without inhibitors (N=18)
HAVEN 5
Adults, adolescents, and children with or without inhibitors (N=85)
HOHOEMI
Children without inhibitors (N=13)
STASEY
Adults and adolescents with inhibitors (N=193)
Other than the Phase 1/2 study, all other studies evaluated approved HEMLIBRA doses.
The chart above is not inclusive of all HEMLIBRA clinical trials, including ongoing and completed pivotal clinical trial programs.
HAVEN 3 and 4 included a long-term extension period, in which patients could switch to any approved HEMLIBRA dose.
Do you know your Account and Community Manager (ACM)?
Your local ACM is part of your hemophilia community and is an expert on HEMLIBRA. ACMs are Genentech employees and do not provide medical advice. Talk to your doctor about your treatment options.
Individual results may vary. Not all patients in the clinical trials had zero bleeds. See results for clinical trial patients with or without factor VIII inhibitors at the top of this page.
When starting HEMLIBRA, a “loading dose” is taken once weekly for 4 weeks. After that, HEMLIBRA offers 3 regular dosing options: once weekly, once every 2 weeks, or once every 4 weeks. Talk to your doctor about dosing.
Hear From an Ambassador
"In the past, I was fearful of telling people about my hemophilia. I didn’t want to stand out because of a medical condition or be treated with “special care.” But today, I have no shame in telling people that I have hemophilia A."
—Tamar, takes HEMLIBRA
Connect With Our Community
Learn more about our unique ambassadors and how you can attend programs and events with the hemophilia A community.