Bottom Line
Part of the Maintenance Hemodialysis mastery module. This page condenses sections 4 and 8.4 of the full white paper, Screening and Health Maintenance in Maintenance Hemodialysis, and the surveillance, isolation, and vaccination sections of the module’s hepatitis B review. Both sources were reference-checked on 2026-09-26.
- Hepatitis C: screen at hemodialysis initiation or transfer (1A), then every 6 months by immunoassay or nucleic acid testing for in-center patients (1B), with ALT at initiation and monthly (2B). A new infection in the unit means testing every patient (1A). After a resolved infection, repeat nucleic acid testing every 6 months to detect reinfection (1B).1
- Hepatitis C is curable on dialysis. Glecaprevir/pibrentasvir is approved for all CKD stages, including dialysis, with sustained virologic response of approximately 97% in dialysis populations. KDIGO recommends antiviral therapy for every transplant candidate with HCV (1A).1
- Hepatitis B testing follows status. Every new patient gets the triple panel (HBsAg, anti-HBs, total anti-HBc). Susceptible patients have HBsAg monthly. Patients immune by vaccination have anti-HBs yearly and, under CDC guidance, no routine HBsAg testing. An isolated anti-HBc result has its own pathway: retest, vaccinate, and test HBV DNA if the patient does not respond.2,3
- Isolation follows HBsAg, not viral load. An HBsAg-positive patient dialyzes in a separate room on a dedicated machine, even with an undetectable HBV DNA on treatment. CDC does not require staff on that station to be immune, but they may not care for susceptible patients at the same time.3,7
- Use a dialysis-dose hepatitis B vaccine: Recombivax HB 40 mcg in 3 doses (0, 1, 6 months) or Engerix-B 40 mcg in 4 doses (0, 1, 2, 6 months). Heplisav-B is not recommended on hemodialysis; CDC and the label state that its safety and effectiveness have not been established in adults on hemodialysis.4,11
- Check the current adult schedule. Hemodialysis is a listed RSV risk condition, so patients qualify from age 50; PCV15, PCV20, or PCV21 are all options; and the 2026–2027 COVID-19 vaccine is recommended for all adults.16,17,18
1. Hepatitis C
Why dialysis patients are screened
Patients on hemodialysis are at increased risk of acquiring hepatitis C through nosocomial transmission within dialysis units. About 7% of chronic hemodialysis patients in the United States are HCV seropositive (7.3% in DOPPS 5, 2012), a rate that has declined with improved infection control and universal precautions.1
KDIGO 2022 recommendations
| Recommendation (KDIGO 2022 Hepatitis C in CKD; guideline number) | Grade |
|---|---|
| Screen all patients for HCV at the initial CKD evaluation (1.1.1) | 1C |
| Screen at hemodialysis initiation or on transfer from another facility (1.1.2), by nucleic acid testing alone, or immunoassay followed by nucleic acid testing if positive (1.1.2.1) | 1A |
| Ongoing screening by immunoassay or nucleic acid testing every 6 months for in-center hemodialysis patients (1.2.1) | 1B |
| A new HCV infection in the unit: test all patients and increase testing frequency (1.2.1.2) | 1A |
| Serum ALT at hemodialysis initiation or transfer (1.2.2, 2B), then monthly (1.2.2.1) | 2B |
| After resolved HCV infection, repeat nucleic acid testing every 6 months to detect reinfection (1.2.1.3) | 1B |
Source: KDIGO 2022 Clinical Practice Guideline for Hepatitis C in CKD, recommendation numbers from its Chapter 1.1
The 6-month schedule is guideline practice, not a federal requirement. CMS incorporates the CDC 2001 hemodialysis infection-control recommendations by reference but excludes their hepatitis C screening provisions; CDC 2001 itself advised anti-HCV testing semiannually and ALT monthly.3,6
Treatment has changed the purpose of screening
Direct-acting antivirals transformed HCV management in CKD. Glecaprevir/pibrentasvir is approved for all CKD stages, including dialysis, and achieves sustained virologic response rates of approximately 97% in dialysis populations (the KDIGO pooled SVR12 was 96.9% across 11 studies). KDIGO recommends antiviral therapy for every transplant candidate with HCV, before or after transplantation and timed with the transplant center (1A), and recommends that kidneys from HCV-infected donors be considered regardless of the recipient’s HCV status (1C).1
HCV screening on dialysis is not only an infection-control measure. An undiagnosed infection delays waitlisting, complicates donor matching, and impairs post-transplant outcomes. Treat the 6-month interval as a minimum, and test every patient when a new infection appears in the unit.1
2. Hepatitis B: Screening, Surveillance, and Isolation
Hemodialysis patients have impaired humoral and cellular immune responses to hepatitis B vaccination. That makes both screening and vaccination core parts of health maintenance, and it is why anti-HBs is followed over time rather than checked once.2,5
Screening at admission
CDC recommends the triple panel — HBsAg, anti-HBs, and total anti-HBc — for every patient starting hemodialysis. The 2001 dialysis recommendations ask that serology be known before admission; if it is not, complete it within 7 days.2,3 The panel separates current infection (HBsAg), immunity (anti-HBs), and past infection (total anti-HBc). The result decides where the patient dialyzes and whether the patient needs vaccination.2,3
Ongoing testing depends on hepatitis B status
| Status | HBsAg | Anti-HBs | Other |
|---|---|---|---|
| Susceptible (unvaccinated, vaccinating, or non-responder) | Monthly | — | Vaccinate; HBV DNA only if HBsAg turns positive |
| Immune by vaccination (anti-HBs ≥10 mIU/mL, anti-HBc negative) | Not required (CDC) | Annually; booster if below 10 mIU/mL | — |
| Immune by past infection (anti-HBs and anti-HBc positive) | No routine follow-up testing (CDC) | Not required | — |
| HBsAg-positive | Confirmed; no repeat | — | Isolation; monthly ALT; HBV DNA per hepatology |
| Isolated anti-HBc | Retest total and IgM anti-HBc, and vaccinate. If anti-HBs stays below 10 mIU/mL after revaccination, test HBV DNA. DNA-negative: treat as susceptible, with monthly HBsAg. DNA-positive: past or low-level infection, with no further testing and no isolation (CDC). | ||
Source: CDC 2001 hemodialysis recommendations, the US standard incorporated by CMS.3,6 Monthly ALT in the CDC scheme belongs to hepatitis C surveillance of anti-HCV-negative patients.3 UK practice differs: the UK Kidney Association tests HBsAg every 6 months in immune patients with anti-HBs above 100 mIU/mL and every 3 months if lower, and at least every 3 months in isolated anti-HBc.8
When a patient turns positive
A new HBsAg seroconversion in the unit triggers a review of every patient’s routine results for additional cases and an investigation of the source. The retests apply to the newly infected patient: HBsAg and anti-HBc, including IgM, 1–2 months later, and HBsAg and anti-HBs 6 months later. UK guidance adds enhanced surveillance of every non-immune patient who dialyzed in the unit since the index patient’s last negative test.3,8
Isolation
Isolation is triggered by HBsAg, not by viral load. A patient whose HBV DNA is undetectable on entecavir, or an “inactive carrier” with a normal ALT, still requires full isolation while HBsAg is positive; isolation ends only when HBsAg is lost.3,7 CDC isolation means:3
- A separate room for HBsAg-positive patients
- Dedicated machines, equipment, instruments, supplies, and medications that are not used on susceptible patients
- Staff who do not care for susceptible patients at the same time, including during the change-over between patients
- No dialyzer reuse
Under CMS surveyor guidance, a separated area one station-width from susceptible patients is allowed only for facilities that were already treating HBV-positive patients in October 2008; facilities opened since February 9, 2009 need an isolation room or a waiver. Machines stay dedicated while HBV-positive patients remain on the census.7
Staff
CDC does not require staff assigned to an HBsAg-positive patient to be immune. It requires that they not care for susceptible patients at the same time; they may care for infected and immune patients on the same shift.3 The UK Kidney Association suggests that non-immune staff not dialyze HBV-infective patients (2B).8 A staff member who does not respond to vaccination repeats the 3-dose series and is retested; if still non-responsive, the staff member is tested for HBsAg, treated as susceptible, and counseled on post-exposure prophylaxis.3,9
Anti-HBs titers decline faster in dialysis patients than in the general population. Annual monitoring is not optional: it is how waning immunity is detected before a nosocomial exposure occurs. Revaccination when titers fall below 10 mIU/mL is standard practice.3
3. Hepatitis B Vaccination on Hemodialysis
Why the dialysis dose is different
Standard-dose hepatitis B vaccine produces adequate antibody responses far less often in dialysis patients than in the general population. High-dose formulations are recommended.3
Which vaccine, which schedule
| Product | Dialysis regimen | Status for adults on hemodialysis |
|---|---|---|
| Recombivax HB, dialysis formulation, 40 mcg (four times the 10-mcg adult dose) | 3 doses at 0, 1, and 6 months | Recommended (CDC)3,4,10 |
| Engerix-B 40 mcg (given as two 20-mcg doses) | 4 doses at 0, 1, 2, and 6 months | Recommended (CDC)3,4 |
| Heplisav-B (HepB-CpG) | Its standard 2-dose adult schedule is not the dialysis regimen | Not recommended. CDC and the FDA label state that safety and effectiveness have not been established in adults on hemodialysis4,11 |
| PreHevbrio (three-antigen vaccine) | — | No longer available in the US; voluntary nationwide recall of remaining supply, November 20244 |
Heplisav-B’s CpG 1018 adjuvant gives higher seroprotection in the general population, and in a CKD trial (GFR 45 mL/min/1.73 m² or lower) 3 doses of it outperformed 4 double doses of Engerix-B, 89.9% versus 81.8%.11,12 That trial did not study dialysis. A 4-dose hemodialysis regimen (weeks 0, 4, 8, and 16) was tested in a completed single-arm trial (NCT03934736): 89.3% seroprotection at week 20 in 75 per-protocol patients, with no comparator.13 Heplisav-B is not FDA-labeled for hemodialysis, and CDC states its safety and effectiveness have not been established in adults on hemodialysis; use it only as off-label, individualized therapy.4,11 The standard choices are Recombivax HB 40 mcg (3 doses) or Engerix-B 40 mcg (4 doses).
After the series
| Step | Recommendation |
|---|---|
| Post-vaccination testing | Anti-HBs 1–2 months after the final dose3 |
| Adequate response | Anti-HBs ≥10 mIU/mL (CDC); the UK Kidney Association uses above 100 mIU/mL and boosts below 1003,8 |
| Nonresponse to the first series | Repeat the complete series once; if the second series also fails, no further vaccination3 |
| Long-term follow-up | Annual anti-HBs in every vaccinated dialysis patient; a booster dose when anti-HBs falls below 10 mIU/mL3 |
Unlike immunocompetent vaccinees, hemodialysis patients are not protected once anti-HBs falls below protective levels, so the annual titer is the safeguard, not a formality.3
Vaccinate before dialysis
Vaccination before dialysis initiation, while immune function is better preserved, produces better responses. Hepatitis B seroconversion rates fall as CKD advances and are lowest in dialysis-dependent ESKD. For patients with progressive CKD approaching dialysis, start the series early rather than waiting for the first treatment.2,5
4. The Rest of the Vaccine Schedule
Hemodialysis patients have impaired humoral and cellular immunity, with lower seroconversion rates and faster antibody waning than the general population.2,5 Each row below was checked against the current CDC page on 2026-09-26; the CDC adult schedule itself was last revised with a July 2, 2025 addendum.14 Product recommendations change, so confirm against the current schedule.
| Vaccine | Schedule | Hemodialysis-specific considerations |
|---|---|---|
| Hepatitis B | Recombivax HB dialysis formulation 40 mcg at 0, 1, 6 months, or Engerix-B 40 mcg at 0, 1, 2, 6 months (Section 3)3,4,14 | Heplisav-B not established in adults on hemodialysis; anti-HBs 1–2 months after the series, then annually, booster below 10 mIU/mL3,4 |
| Influenza | Annually, any age-appropriate vaccine (2026–27 vaccines are trivalent)15 | Age 65 and older: high-dose, recombinant, or adjuvanted vaccine preferred; no dialysis-specific preference under 6515 |
| Pneumococcal | PCV15, PCV20, or PCV21; if PCV15, follow with PPSV2316 | Chronic renal failure is on CDC’s immunocompromising-condition list, so vaccinate at any adult age (universal at 50 and older), and PPSV23 may follow PCV15 after 8 weeks rather than 1 year14,16 |
| COVID-19 | 2026–2027 vaccine recommended for all adults 18 and older17 | Moderately or severely immunocompromised patients follow CDC’s separate schedule17 |
| RSV | Single dose for all adults 75 and older, and for adults 50–74 at increased risk18 | End-stage renal disease or dependence on hemodialysis is a listed risk condition, so patients on hemodialysis qualify from age 50; not an annual vaccine18 |
| Tdap | 1 dose of Tdap if never given, then Td or Tdap every 10 years14 | Standard dosing |
| Recombinant zoster (Shingrix) | 2 doses, 2–6 months apart, age 50 and older19 | Also from age 19 if immunodeficient or immunosuppressed (for example, transplant immunosuppression), with dose 2 at 1–2 months; ESKD itself is not a listed indication19 |
5. Monitoring at a Glance
| Test or action | Frequency on hemodialysis | Key point |
|---|---|---|
| HCV screen | At initiation or transfer, then every 6 months (in-center) | Nucleic acid test alone, or immunoassay followed by nucleic acid test1 |
| ALT | At initiation or transfer, then monthly | KDIGO 2B1 |
| New HCV infection in the unit | Test every patient; increase frequency | KDIGO 1A1 |
| HCV nucleic acid test after resolved infection | Every 6 months | Detects reinfection1 |
| HBsAg, anti-HBs, total anti-HBc | Before admission; if unknown, within 7 days | Result determines isolation and vaccination2,3 |
| HBsAg in susceptible patients | Monthly | Includes patients still vaccinating and non-responders3 |
| Anti-HBs in patients immune by vaccination | Annually | Booster below 10 mIU/mL; no routine HBsAg (CDC)3 |
| Isolated anti-HBc | Retest, vaccinate, then HBV DNA if no response | No isolation (CDC)3 |
| Anti-HBs after a vaccine series | 1–2 months after the final dose | ≥10 mIU/mL is an adequate response3 |
| Other vaccines | Per the CDC adult schedule | Annual influenza; PCV15, PCV20, or PCV21; COVID-19 2026–27; RSV from age 50; Tdap; recombinant zoster from age 5014,15,16,17,18,19 |
6. Six Situations in the Dialysis Unit
These sketches apply the recommendations above. They are illustrative teaching examples, not patients.
A patient transfers from another unit
KDIGO recommends HCV screening on transfer from another facility (1A), and CDC recommends the hepatitis B triple panel, known before admission or completed within 7 days.1,2,3 Obtain both. The hepatitis B result decides whether the patient needs an isolation room and dedicated machine or, if susceptible, monthly HBsAg and a vaccine series.3
The CKD-clinic vaccine that did not take
A patient completed a hepatitis B series before dialysis, and anti-HBs at dialysis start is below 10 mIU/mL. That is a nonresponse to the first series. Repeat the complete series once, now with a dialysis-dose product (Recombivax HB 40 mcg in 3 doses or Engerix-B 40 mcg in 4 doses), check anti-HBs 1–2 months after the final dose, and test HBsAg monthly in the meantime. If the second series also fails, further vaccination is not recommended.3,4
The titer that slipped
A patient who responded to vaccination two years ago now has an annual anti-HBs below 10 mIU/mL. This is the waning immunity that annual monitoring exists to catch, and it happens faster on dialysis than in the general population. Give a booster dose.3
An isolated anti-HBc
The admission panel shows anti-HBc positive with HBsAg and anti-HBs negative. Retest total and IgM anti-HBc and start vaccination. If anti-HBs stays below 10 mIU/mL after revaccination, test HBV DNA: a negative result means the patient is managed as susceptible, with monthly HBsAg; a positive result indicates past or low-level infection, with no further testing and no isolation under CDC guidance.3
“Can we use Heplisav-B instead?”
Heplisav-B’s higher seroprotection in the general population makes it a frequent question in a unit full of poor vaccine responders. For adults on hemodialysis the answer is no, except as off-label, individualized therapy: CDC and the label state that its safety and effectiveness have not been established in this population, its 2-dose schedule is not the dialysis regimen, and the only hemodialysis data come from one single-arm trial without a comparator. Use Recombivax HB 40 mcg or Engerix-B 40 mcg.4,11,13
The transplant candidate cured of hepatitis C
A patient on the transplant waiting list completed antiviral therapy and achieved sustained virologic response. KDIGO recommends antiviral therapy for every transplant candidate with HCV, timed with the transplant center (1A). Because reinfection remains possible in the dialysis setting, KDIGO also recommends nucleic acid testing every 6 months after a resolved infection (1B).1
7. Evidence Gaps
- Heplisav-B on hemodialysis. The only hemodialysis data are one completed single-arm trial of a 4-dose regimen (89.3% seroprotection at week 20, 75 per-protocol patients, no comparator). There is no comparative trial against the dialysis-dose vaccines, and the product is not labeled for hemodialysis.11,13
- How often to test immune patients. CDC does not require routine HBsAg testing in patients immune by vaccination; the UK Kidney Association tests every 3–6 months and uses a higher anti-HBs threshold. The two approaches have not been compared.3,8
- Vaccines other than hepatitis B. The influenza, pneumococcal, COVID-19, RSV, and zoster recommendations come from the CDC adult schedule and its risk-condition lists rather than from dialysis trials.14,15,16,17,18,19 Hemodialysis patients respond less well to vaccines and lose antibody faster.2,5
8. At the Chair
- Every new or transferring patient needs hepatitis B status (HBsAg, anti-HBs, total anti-HBc) and a hepatitis C screen at initiation or transfer. The hepatitis B result determines station, machine, and staff assignment.
- Know each patient’s hepatitis B category: susceptible patients have HBsAg monthly; patients immune by vaccination have anti-HBs yearly; an isolated anti-HBc follows its own pathway.
- Check the hepatitis B vaccine before it is given. The dialysis products are Recombivax HB 40 mcg (3 doses) and Engerix-B 40 mcg (4 doses). Heplisav-B is not the hemodialysis vaccine.
- Isolation continues while HBsAg is positive, even when the viral load is undetectable.
- Report a new positive hepatitis B or C result at once. A new infection in the unit changes testing for everyone.
Chair-side reference: Nursing card N11 — Infection control: hepatitis B/C, vaccination, isolation.
References
Claims and references on this page are drawn from the source white paper (Screening and Health Maintenance in Maintenance Hemodialysis, sections 4 and 8.4) and the module’s hepatitis B review (sections 6–10). Both reference lists were re-verified on 2026-09-26: PubMed identifiers resolved against PubMed, and CDC, CMS, and label sources checked on their official pages. References are renumbered for this page.
- KDIGO Hepatitis C Work Group. KDIGO 2022 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease. Kidney Int. 2022;102(6S):S129-S205. PMID 36410841
- Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and testing for hepatitis B virus infection: CDC recommendations — United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. PMID 36893044
- Centers for Disease Control and Prevention. Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep. 2001;50(RR-5):1-43. PMID 11349873
- Centers for Disease Control and Prevention. Hepatitis B vaccine administration (health care providers). Page last updated September 18, 2025; accessed 2026-09-26. cdc.gov. Not PubMed-indexed.
- Flythe JE, Watnick S. Dialysis for chronic kidney failure: a review. JAMA. 2024;332(18):1559-1573. PMID 39356511
- 42 CFR §494.30 — Condition: Infection control (incorporates CDC MMWR 2001;50(RR-05) pages 18-28, “with the exception of screening for hepatitis C”). ecfr.gov
- Centers for Medicare & Medicaid Services. ESRD Interpretive Guidance, Version 1.1 (2015), tags V128-V130. cms.gov
- Garthwaite E, Reddy V, Douthwaite S, et al. Clinical practice guideline management of blood borne viruses within the haemodialysis unit. BMC Nephrol. 2019;20(1):388. PMID 31656166
- Schillie S, Murphy TV, Sawyer M, et al. CDC guidance for evaluating health-care personnel for hepatitis B virus protection and for administering postexposure management. MMWR Recomm Rep. 2013;62(RR-10):1-19. PMID 24352112
- Recombivax HB (hepatitis B vaccine, recombinant). Prescribing information. Merck Sharp & Dohme; November 2025. DailyMed
- Heplisav-B (hepatitis B vaccine, recombinant, adjuvanted). Prescribing information (section 8.6, adults on hemodialysis; section 14). Dynavax Technologies; February 2026. DailyMed
- Janssen RS, Mangoo-Karim R, Pergola PE, et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine. 2013;31(46):5306-5313. PMID 23727422
- Awad AM, Ntoso A, Connaire JJ, et al. An open-label, single-arm study evaluating the immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) in adults receiving hemodialysis. Vaccine. 2021;39(25):3346-3352. PMID 34001345
- Centers for Disease Control and Prevention. Adult immunization schedule notes and schedule by medical condition, 2025 (addendum July 2, 2025); accessed 2026-09-26. cdc.gov
- Centers for Disease Control and Prevention. Interim clinical considerations for the use of seasonal influenza vaccines in the United States, 2026-2027 season. September 1, 2026; accessed 2026-09-26. cdc.gov
- Centers for Disease Control and Prevention. Pneumococcal vaccine recommendations. Page last updated February 25, 2026; accessed 2026-09-26. cdc.gov
- Centers for Disease Control and Prevention. 2026-2027 COVID-19 vaccination guidance for people who are not immunocompromised. September 23, 2026; accessed 2026-09-26. cdc.gov
- Centers for Disease Control and Prevention. RSV vaccine guidance for adults. Page last updated February 24, 2026; accessed 2026-09-26. cdc.gov
- Centers for Disease Control and Prevention. Shingles vaccine recommendations. Page last updated October 22, 2024; accessed 2026-09-26. cdc.gov
Also in this module
- Catheter care, lock solutions, and bloodstream infection
- Cancer, acquired cystic disease/RCC, and thyroid screening
- Cardiometabolic monitoring: lipids, statins, glycemic markers, and cardiovascular screening
- Maintenance Hemodialysis module index
Related pages
- Enterococcal endocarditis in hemodialysis
- Screening and Health Maintenance in Maintenance Hemodialysis, sections 4 and 8.4 (full white paper)