Gilead: cross-border access for the specialty portfolio

Quick orientation

Gilead Sciences, Inc. is a US-headquartered biopharmaceutical company based in Foster City, California. Gilead's specialty footprint is anchored in HIV (the Biktarvy, Descovy, Genvoya, Symtuza-via-Janssen, and the long-acting injectable franchise Sunlenca), hepatitis C and B (Sovaldi, Harvoni, Epclusa, Vemlidy, Vosevi), oncology (the Immunomedics-origin Trodelvy in triple-negative and HR-positive HER2-low breast cancer and urothelial cancer), cell therapy via Kite Pharma (Yescarta and Tecartus CAR-T products), and liver disease (Livdelzi for primary biliary cholangitis acquired via the 2024 CymaBay acquisition).

Portfolio in cross-border NPP scope

Trodelvy (sacituzumab govitecan)

Trop-2-directed antibody-drug conjugate approved for metastatic triple-negative breast cancer, HR-positive HER2-low or HER2-negative metastatic breast cancer, and locally advanced or metastatic urothelial carcinoma. US WAC at the standard dosing schedule runs above $25,000 per cycle. International requests cluster around triple-negative breast cancer patients in MENA and India whose payer denies coverage at the locally registered indication, and around HER2-low patients where the indication has not yet been added locally.

Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel)

Kite Pharma autologous CD19-directed CAR-T products. Yescarta is approved for relapsed and refractory large B-cell lymphoma (second-line and later), follicular lymphoma, and DLBCL high-risk after first-line. Tecartus is approved for relapsed and refractory mantle cell lymphoma and ALL. Reserve Meds does not coordinate autologous CAR-T cross-border because of the apheresis-to-manufacturing logistics anchored to a US Kite site; we redirect those inquiries to medical-travel pathway documentation.

Sunlenca (lenacapavir)

First-in-class capsid inhibitor for HIV approved as twice-yearly subcutaneous injection for heavily treatment-experienced HIV-1 patients with multi-class drug resistance, and with expanded approval for HIV pre-exposure prophylaxis. International requests come from heavily-treated multi-class-resistant HIV patients in MENA and India where the locally available salvage options have been exhausted, and from PrEP patients who prefer twice-yearly dosing.

Biktarvy and Descovy

Biktarvy is the bictegravir, emtricitabine, and tenofovir alafenamide fixed-dose combination single-tablet regimen for HIV. Descovy is the emtricitabine and tenofovir alafenamide combination for HIV treatment and PrEP. International requests come from HIV patients in MENA and India who want the FDA-labeled US single-tablet regimen, especially where the locally available HIV regimens still use older tenofovir disoproxil fumarate-based combinations.

Vemlidy (tenofovir alafenamide)

Antiviral approved for chronic hepatitis B infection in adults and adolescents with compensated liver disease. International requests come from chronic HBV patients in MENA and India where Vemlidy specifically is preferred over tenofovir disoproxil fumarate for the bone and renal safety profile.

Sovaldi, Harvoni, Epclusa, Vosevi

The Gilead hepatitis C direct-acting antiviral franchise. Cross-border requests for these products have declined as generic versions have become available globally, but specific complex HCV cases (genotype-specific failures, decompensated cirrhosis) still route through Reserve Meds for the original Gilead product.

Livdelzi (seladelpar, ex-CymaBay)

Oral PPAR-delta agonist approved for primary biliary cholangitis (PBC) in adults with inadequate response to or intolerance of ursodeoxycholic acid. International requests come from PBC patients in MENA and India who have failed UDCA monotherapy and where the locally registered options remain limited to obeticholic acid.

Why patients route Gilead products through cross-border NPP

Three patterns dominate. First, the Trodelvy ADC oncology franchise is expanding indications faster than MENA and India payer formularies can add them.

Second, Sunlenca and the HIV-resistance-salvage population is small but high-acuity: heavily treatment-experienced multi-class-resistant HIV patients in MENA and India have essentially no locally available options.

Third, Livdelzi is too new globally for most non-US labels; PBC patients on UDCA failure represent a niche population that often routes through cross-border NPP for any disease-modifying therapy.

The Advancing Access program is the Gilead patient assistance program for US residents only. International patients route as cash-pay.

Manufacturer engagement posture

Reserve Meds coordinates Gilead-manufactured US product through DSCSA-compliant specialty wholesaler channels. We are not an authorized Gilead distributor; we are an independent named-patient program coordinator. Patient assistance program coverage does not extend to cross-border patients. All Reserve Meds orders are cash-pay at firm-quote pricing.

For Gilead, Kite, and Immunomedics-legacy market access teams: Reserve Meds maintains structured demand visibility across the HIV, hepatitis, oncology, and PBC franchises. If your group is sizing pre-registration demand or evaluating named-patient program activity in MENA and India, we are open to a structured conversation under NDA.

Common cross-border destinations for the Gilead portfolio

The HIV franchise (Biktarvy, Descovy, Sunlenca) concentrates in Egypt, India, and the Gulf. The Trodelvy oncology franchise tracks oncology specialist concentration in India, Saudi Arabia, UAE, and Egypt. The hepatitis franchise serves general gastroenterology and hepatology across MENA and India. Livdelzi is heaviest in tertiary hepatology centers.

What Reserve Meds provides

For every Gilead product order, Reserve Meds coordinates DSCSA chain-of-custody documentation; cold-chain validated logistics where required (Trodelvy, Sunlenca); country regulatory pathway expertise covering named-patient import approval; and a single patient-facing coordinator. We do not replace the patient's treating physician. A US-licensed pharmacist reviews every prescription before dispensing.

Next step for patients

Patients or caregivers who have a treating physician's prescription for a Gilead product and want a firm quote can start a request below.

Start a request for a Gilead product

Next step for Gilead teams

If you are on the Gilead, Kite, or Immunomedics-legacy access, medical affairs, or international market access team and want to discuss coordinated named-patient program demand from MENA and India, reach us at [email protected]. We will share aggregated demand views under NDA.

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