Isentress Shortage: What Providers and Prescribers Need to Know in 2026

Isentress (Raltegravir) remains a clinically important integrase strand transfer inhibitor (INSTI) in the HIV treatment armamentarium, particularly for specific patient populations. This briefing provides prescribers with an up-to-date overview of Isentress availability, supply dynamics, prescribing considerations, and tools to support patient access in 2026.

Current Supply Status

As of early 2026, Isentress is not listed on the FDA Drug Shortage Database or the ASHP Drug Shortage List. There is no widespread manufacturing disruption affecting Raltegravir production by Merck & Co.

However, clinicians should be aware that patients frequently report difficulty filling Isentress prescriptions at retail pharmacies. This is primarily a distribution and stocking issue rather than a true supply shortage. The high cost of the medication (approximately $1,900–$2,500 per 30-day supply at retail) means many pharmacies do not maintain routine inventory unless they serve an established HIV patient population.

Timeline and Key Developments

• October 2007: FDA approval of Isentress (Raltegravir) 400 mg film-coated tablets — the first integrase inhibitor approved for HIV treatment
• 2017: FDA approval of Isentress HD (600 mg tablets) for once-daily dosing (as 1200 mg, two tablets) in treatment-naive and virologically suppressed patients
• May 2025: Lupin Ltd receives FDA approval for generic Raltegravir Potassium tablets
• Early 2026: Generic Raltegravir availability remains limited; widespread pharmacy distribution has not yet materialized

Prescribing Implications

Where Isentress Remains Clinically Relevant

While DHHS guidelines now recommend second-generation INSTIs (Dolutegravir, Bictegravir) as preferred first-line agents, Raltegravir retains important clinical roles:

• Pregnancy: Raltegravir has extensive safety data in pregnancy and remains a preferred INSTI for pregnant individuals per DHHS Perinatal Guidelines, particularly when rapid viral load reduction is needed
• Neonatal HIV: Isentress oral granules are approved for neonates weighing ≥2 kg, making it one of the few antiretrovirals available for this population
• Drug interaction considerations: Raltegravir is primarily metabolized via UGT1A1 glucuronidation, resulting in fewer CYP450-mediated drug interactions compared to some alternatives. This can be advantageous for patients on complex medication regimens
• Treatment-experienced patients: May be appropriate for patients with specific resistance profiles or intolerance to other INSTIs

Switching Considerations

For patients experiencing difficulty accessing Isentress, consider the following evidence-based alternatives:

• Dolutegravir (Tivicay): Higher barrier to resistance, once-daily dosing, generic available. Preferred first-line per DHHS guidelines. Available in combination as Triumeq and Dovato
• Bictegravir (in Biktarvy): Single-tablet regimen with high efficacy and resistance barrier. Widely available at most pharmacies
• Cabotegravir + Rilpivirine (Cabenuva): Long-acting injectable option for virologically suppressed patients. Monthly or every-two-month dosing eliminates daily pill burden

Before switching, review the patient's resistance history, current viral load, concomitant medications, and any pregnancy-related considerations. Cross-resistance between first-generation INSTIs (Raltegravir, Elvitegravir) and second-generation INSTIs (Dolutegravir, Bictegravir) is possible but not universal — resistance testing is recommended.

Availability and Access

Pharmacy Stocking Patterns

Providers should be aware that Isentress is frequently not stocked at general retail pharmacies. The most reliable dispensing channels include:

• Specialty pharmacies with HIV medication focus
• Hospital outpatient pharmacies and clinic-based pharmacies at Ryan White-funded facilities
• Mail-order specialty pharmacies contracted with major insurers
• 340B pharmacies at eligible covered entities

Insurance and Coverage

Coverage patterns for Isentress in 2026:

• Commercial plans: Generally covered, often on specialty or non-preferred brand tier. Prior authorization may be required, particularly for new starts (given guideline preference for Dolutegravir/Bictegravir)
• Medicare Part D: Covered, with $2,000 annual out-of-pocket cap effective since 2025
• Medicaid: Covered in most states
• ADAP: Covered by most state AIDS Drug Assistance Programs
• Ryan White Program: Available through Ryan White-funded pharmacies

Cost and Patient Assistance

Understanding cost barriers is essential for maintaining adherence:

• Retail cash price: $1,900–$2,500/month
• Merck copay savings card: Up to $6,800/year for commercially insured patients (not valid for government insurance)
• Merck Patient Assistance Program: Provides Isentress free of charge to eligible uninsured patients (merckhelps.com)
• SUPPORT Program: Merck's comprehensive support program assists with insurance navigation, copay assistance, and pharmacy location

For detailed patient-facing cost information, refer patients to our guide on saving money on Isentress.

Tools and Resources for Providers

Medfinder for Providers

Medfinder for Providers enables clinical teams to check real-time pharmacy inventory for Isentress and other HIV medications. This tool can help you direct patients to pharmacies that have their medication in stock, reducing gaps in treatment.

Recommended Workflow

1. When prescribing Isentress: Verify with the patient's pharmacy that they stock or can order it before the patient leaves the clinic
2. For refill issues: Use Medfinder for Providers to identify alternative pharmacies with stock
3. For cost barriers: Initiate Merck's SUPPORT Program enrollment during the clinic visit
4. For ongoing access issues: Consider referral to a specialty pharmacy with guaranteed HIV medication inventory
5. For switching: Document resistance testing, review DHHS guidelines, and counsel the patient on the new regimen

Additional Resources

• Provider's guide to helping patients find Isentress
• How to help patients save money on Isentress
• DHHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV (clinicalinfo.hiv.gov)
• Merck SUPPORT Program: merckhelps.com

Looking Ahead

Several developments may affect Isentress prescribing and availability through 2026 and beyond:

• Generic Raltegravir market entry: As Lupin and potentially other manufacturers bring generic Raltegravir to market, pricing and availability should improve. Monitor for formulary changes that may affect tier placement
• Evolving guidelines: DHHS guidelines continue to favor second-generation INSTIs. Raltegravir's role may become more niche, focused on pregnancy, neonatal use, and patients with specific drug interaction needs
• Long-acting therapies: The continued expansion of injectable options (Cabenuva, Lenacapavir) may reduce demand for oral INSTIs over time

Final Thoughts

While Isentress is not in a formal shortage, access challenges are real and can directly impact treatment adherence and outcomes. Providers play a critical role in anticipating these barriers, using available tools like Medfinder for Providers, and proactively connecting patients with support programs.

For patients who are stable on Isentress and experiencing no access issues, continued use is appropriate. For those facing persistent availability or cost barriers, evidence-based switching to Dolutegravir or Bictegravir-based regimens is well-supported by current guidelines.