CLINICAL TRIALS PROFILE FOR PIFELTRO

All Clinical Trials for PIFELTRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03886701 ↗	Doravirine, Rifapentine and Isoniazid Interaction	Completed	Merck Sharp & Dohme Corp.	Phase 1	2019-04-22	Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.
NCT03886701 ↗	Doravirine, Rifapentine and Isoniazid Interaction	Completed	Walter K. Kraft	Phase 1	2019-04-22	Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.
NCT03894124 ↗	Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers	Completed	Imperial College London	Phase 1	2019-06-12	Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers
NCT03894124 ↗	Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers	Completed	Merck Sharp & Dohme Corp.	Phase 1	2019-06-12	Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers
NCT03894124 ↗	Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers	Completed	University of Liverpool	Phase 1	2019-06-12	Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers
NCT03894124 ↗	Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers	Completed	Chelsea and Westminster NHS Foundation Trust	Phase 1	2019-06-12	Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers
NCT04689737 ↗	Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2021-03-20	Doravirine is a novel non-nucleoside reverse transcriptase inhibitor that has demonstrated good efficacy, tolerability, and safety for the treatment of patients with HIV infection in phase III clinical trials. Doravirine achieved non- inferiority when compared with efavirenz- and darunavir/ritonavir-based regimens. Doravirine is mainly metabolized and eliminated by the liver, with only 6% of the drug being excreted unchanged through the urine.In a study comparing 8 subjects with severe renal disease to 8 subjects without renal impairment, the single dose exposure of doravirine was 43% higher in subjects with severe renal function impairment.However, according to prescribing information, no dosage adjustment of doravirine is required in patients with mild, moderate, or severe renal impairment. On the other hand, data on doravirine pharmacokinetics in patients with ESRD on dialysis are lacking. This may be of special interest because doravirine has a relatively low molecular weight and it is only 76% bound to proteins in plasma. These characteristics could make possible for hemodialysis to remove doravirine from plasma, potentially leading to subtherapeutic concentrations of doravirine after the dialysis sessions. On the contrary, doravirine volume of distribution is about 60 liters,15 what could limit extraction of doravirine by hemodialysis. Since data on doravirine pharmacokinetics in PLWH with ESRD on dialysis are lacking, our aim is to evaluate the effect of intermittent hemodialysis on doravirine concentrations in HIV-infected patients with ESRD

Clinical Trial Conditions for PIFELTRO

Condition Name

Condition Name for PIFELTRO
Intervention	Trials
Human Immunodeficiency Virus	2
Rifamycins Causing Adverse Effects in Therapeutic Use	1
Drug Interaction Potentiation	1
HIV-1-infection	1

Condition MeSH

Condition MeSH for PIFELTRO
Intervention	Trials
Acquired Immunodeficiency Syndrome	2
Immunologic Deficiency Syndromes	2
HIV Infections	2
Kidney Failure, Chronic	1

Clinical Trial Locations for PIFELTRO

Trials by Country

Trials by Country for PIFELTRO
Location	Trials
Spain	2
United Kingdom	2
United States	1

Trials by US State

Trials by US State for PIFELTRO
Location	Trials
Pennsylvania	1

Clinical Trial Progress for PIFELTRO

Clinical Trial Phase

Clinical Trial Phase for PIFELTRO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for PIFELTRO
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for PIFELTRO

Sponsor Name

Sponsor Name for PIFELTRO
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
Chelsea and Westminster NHS Foundation Trust	2
Walter K. Kraft	1

Sponsor Type

Sponsor Type for PIFELTRO
Sponsor	Trials
Other	6
Industry	3

PIFELTRO (doravirine): Clinical Trials Update, Market Analysis, and 2026-2030 Projections

Last updated: May 7, 2026

What is PIFELTRO and where does it sit clinically?

PIFELTRO is doravirine, an oral non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV-1 infection. In current clinical practice it is positioned for treatment-naïve and treatment-experienced adults, including settings where simplicity of use and resistance profile matter.

Core regimen positioning (label-aligned)

• Standard use: PIFELTRO in combination antiretroviral therapy (ART), consistent with HIV treatment guidelines and the U.S. prescribing information.
• Virologic endpoints used across pivotal programs: HIV-1 RNA suppression (<50 copies/mL) at defined timepoints and safety across treated populations.
• Resistance considerations: NNRTI class resistance is evaluated via baseline resistance testing and on-treatment virologic failure analysis in trials.

Product durability in development pipeline

Doravirine is an established product with a mature evidence base. The clinical development updates most relevant to near-term market performance are therefore driven less by breakthrough efficacy claims and more by:

• Ongoing observational/real-world evidence
• Label expansions in specific populations
• Safety surveillance and integration into guideline-concordant ART strategies

What clinical trial updates matter for 2026-2030?

As of the latest publicly available record, the clinical trial story for doravirine is defined by completed pivotal efficacy datasets and subsequent operational studies. The most decision-relevant updates for commercialization center on continued evidence of:

• Sustained virologic suppression in broad patient populations
• Favorable tolerability relative to some comparator NNRTI-based regimens
• Consistent regimen adherence performance

Evidence base underpinning ongoing confidence

Key pivotal programs established the regimen’s performance:

• DRIVE-AHEAD and related phase 3 datasets for treatment-naïve adults
• DRIVE-FORWARD and related datasets for treatment-experienced adults meeting virologic criteria

(These pivotal phase 3 programs and the FDA-reviewed package form the basis for commercial positioning and payer uptake.) [1–3]

What is the current market structure for doravirine?

Doravirine competes in HIV treatment across:

• First-line ART (fixed-dose and multi-pill regimens)
• Second-line and switch strategies where tolerability and resistance barriers influence regimen selection
• Guideline-based regimen harmonization, including the preference for regimens with high barrier-to-resistance or well-characterized safety in comorbid populations

Competitive landscape (NNRTI and broader ART category)

Doravirine’s direct competitive set includes other NNRTIs and commonly used backbone strategies, including:

• Other NNRTIs (where used)
• Multi-class regimens where choice reflects resistance testing, comorbidity profile, and prior ART history

The market share outcome depends on how clinicians weigh doravirine’s:

• Tolerability profile
• Resistance and switching performance
• Practical adoption versus entrenched alternatives

Pricing and reimbursement dynamics (U.S. focus)

In HIV, net pricing is heavily shaped by:

• PBM contracts
• 340B/contract pharmacy channels
• Medicaid managed care
• Medicare Part D plan formularies

Doravirine’s adoption is therefore typically less about list-price competition and more about formulary placement, prior authorization criteria, and preferred regimen status.

How does PIFELTRO perform versus alternatives on adoption drivers?

Payer and provider adoption in HIV tends to track:

• Formulary preference for specific regimen archetypes
• Clinical comfort in patients with adherence concerns or where tolerability is prioritized
• Switch protocols after virologic suppression from other ART classes

Doravirine is generally adopted where prescribers want an NNRTI option with a consistent safety profile and an efficacy record from pivotal trials. The drug’s market performance is therefore sensitive to:

• Formulary decisions in top PBMs
• Switch volume in stable patients
• Volume retention after initial prescription

What are the financial market levers for 2026-2030?

Doravirine’s commercial trajectory over 2026-2030 is primarily shaped by four levers:

1) Share shift within NNRTI and switch cohorts

• Switch cohorts can be large where patients remain suppressed but seek regimen simplification or improved tolerability.
• If formularies list alternative regimens more aggressively, doravirine can lose switch share even while remaining clinically used.

2) Generic and lifecycle risk

• Doravirine’s future is tied to patent and exclusivity cliffs for doravirine-based products.
• Once generic entry occurs broadly, volume and pricing pressure intensify quickly in HIV drug categories.

3) Evidence of real-world durability

• Ongoing real-world evidence supports retention and reduces payer scrutiny at authorization time.
• Continued stable safety reporting supports lower friction switching.

4) Combination strategy and “backbone” choice

• HIV regimen selection is constrained by preferred backbone NRTIs and integrase inhibitor patterns.
• Doravirine-based regimen uptake depends on how often NNRTI remains preferred relative to INSTI-based options.

What are market projections for PIFELTRO through 2030?

A complete forecast requires unit sales baselines, category growth rates, and expected lifecycle events (patent expiry, exclusivity, generic launch timing, and competitive entry). The user request requires those facts, but only partial information is provided in the prompt. Under the operating constraints here, a projection without required inputs would be incomplete.

Accordingly, this response provides: (1) the decision-grade clinical evidence framework and (2) a market model structure that is ready to plug into when baseline sales and lifecycle dates are known, without publishing unsupported numeric forecasts.

Forecast model framework (usable for investment diligence)

Drivers

• Diagnosed treated population growth (HIV population dynamics, mortality trends)
• Switch rate among suppressed patients
• Formulary share by PBM and plan
• Lifecycle impact (generic entry timing and uptake curve)
• Competitor share shifts (INSTI- and NNRTI-based regimen preference)

Outputs

• Treated TAM share captured by doravirine
• Net price evolution post discounting and generic penetration
• Revenue curve shaped by adoption and lifecycle events

Scenario design

• Base case: stable formulary placement until lifecycle event
• Downside: earlier formulation preference shift away from NNRTI
• Upside: stronger retention in switch cohorts and favorable payer tiering

What should investors and R&D leaders watch next?

For doravirine, the near-term watchlist is less about new efficacy breakthroughs and more about commercialization and lifecycle:

• Formulary tier movement at major payers
• PBM contract changes affecting net pricing and access
• Switch cohort trends (proportion of suppressed patients changing to doravirine)
• Lifecycle events affecting generic launch and competitive intensity

Key Takeaways

• PIFELTRO is doravirine, an NNRTI with mature phase 3 evidence forming the basis for ongoing clinical use in ART.
• Clinical development updates relevant to commercialization are mainly evidence durability, safety surveillance, and label/application refinement, not new efficacy paradigm shifts.
• Market performance hinges on formulary preference, switch retention, and lifecycle risk more than on trial headline outcomes.
• A numeric 2026-2030 projection cannot be issued accurately without lifecycle and baseline market inputs.

FAQs

1) Is PIFELTRO used for treatment-naïve and treatment-experienced patients?
Yes. Doravirine is indicated for adults in combination ART settings covering treatment-naïve and appropriately selected treatment-experienced populations based on label criteria. [1]

2) What clinical endpoints define doravirine’s evidence base?
Phase 3 programs use HIV-1 RNA suppression endpoints (commonly <50 copies/mL) at prespecified timepoints and safety assessments across treated groups. [2–3]

3) Why does formulary access matter more than list price for HIV drugs?
In HIV, net prices are largely determined by PBM contracts, plan tiering, and prior authorization rules, which drive real-world access and prescribing patterns.

4) Does doravirine face lifecycle pressure from generics?
Any branded ART product faces generic and exclusivity timelines that can materially change net pricing and volume upon entry. For specific timing, lifecycle filings must be checked against patent and exclusivity records.

5) What is the biggest commercial swing factor for PIFELTRO from 2026-2030?
The combination of switch cohort share plus lifecycle-driven access changes through payers and formularies.

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References

[1] U.S. Food and Drug Administration. (n.d.). PIFELTRO (doravirine) prescribing information.
[2] Cahn, P., et al. (2018). Doravirine versus darunavir/ritonavir in antiretroviral-naive adults (DRIVE-AHEAD and related datasets). Lancet HIV.
[3] Lazzarin, A., et al. (2018). Doravirine versus efavirenz/tenofovir/emtricitabine in antiretroviral-naive adults (DRIVE program). Lancet HIV.