Watch 04: October 2022

 

The HIV/HCV Co-Infection Watch is a project of the Community Access National Network (CANN) designed to research, monitor and report on HIV and Hepatitis C (HCV) co-infection in the United States. The October 2022 Watch includes timely updates herein. To read the project disclaimer and/or methodology, CLICK HERE.

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1. FINDINGS

The following is a summary of the key findings for October 2022:

AIDS Drug Assistance Programs:

There are 56 State and Territorial AIDS Drug Assistance Programs (ADAPs) in the United States, 48 of which offer some form of coverage for Hepatitis C (HCV) treatment. Of those programs, 46 have expanded their HCV coverage to include the Direct-Acting Antiviral (DAA) regimens that serve as the current Standard of Care (SOC) for Hepatitis C treatment. Two (2) programs offer only Basic Coverage and 8 programs offer No Coverage. Two (2) programs cover only a single Direct-Acting Antiviral. Three (3) territories – American Samoa, Marshall Islands, and Northern Mariana Islands – are not accounted for in this data. A state-by-state Drug Formulary breakdown of coverage is included in the October 2022 Updates, with accompanying drug-specific maps in Figures 1 – 10.

Medicaid Programs:

There are 59 State and Territorial Medicaid programs in the United States, and data is represented for all fifty (50) states and the District of Columbia. As of October 01, 2016, all 50 states and the District of Columbia offer Expanded Coverage. A state-by-state PDL breakdown of coverage is included in the October 2022 Updates, with accompanying drug-specific maps in Figures 11 – 20.

Harm Reduction Programs:

Every State and Territory in the United States currently provides funding for low-income people living with substance abuse issues to enter state-funded rehabilitation services (National Center for Biotechnology Information, n.d.). Forty-four (44) States, the District of Columbia and three (3) Territories currently have Syringe Services Programs (SSPs) in place, regardless of the legality. Fifty (50) States and the District of Columbia have expanded access to Naloxone to avert opioid drug overdoses. Fifty (50) States and the District of Columbia have Good Samaritan laws or statutes that provide some level of protection for those rendering emergency services during drug overdoses. Forty-seven (47) States, the District of Columbia, and Guam make reporting to Prescription Drug Monitoring Programs (PDMPs) mandatory, requiring physicians and/or pharmacists to report prescriptions written or filled to a state agency for monitoring. Fifty (50) States and the District of Columbia have Opioid-Specific Doctor Shopping Laws preventing patients from attempting to receive multiple prescriptions from numerous physicians, and/or from withholding information in order to receive prescriptions. Forty-five (45) states and the District of Columbia mandate a Physical Exam Requirement in order for patients to receive a prescription for opioid drugs. Thirty-Five (35) states have in place an ID Requirement mandating that people filling opioid prescriptions present a state-issued ID prior to receiving their prescription. Forty-five (45) states and the District of Columbia require prescribing physicians to attend mandatory and continuing opioid prescribing education sessions. Forty-seven (47) states and the District of Columbia have Medicaid doctor/pharmacy Lock-In programs that require patients to receive prescriptions from a single physician and/or fill prescriptions from a single pharmacy. A state-by-state program breakdown is included in the October 2022 Updates, with accompanying drug-specific maps in Figures 21-29.

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2. AIDS DRUG ASSISTANCE PROGRAMS (ADAPs) & HCV THERAPIES

Of the 56 respective State and Territorial ADAPs, only 8 (KS, KY, OH, UT, VT, GU, PW, VI) do not offer any coverage for HCV drug therapies. States whose formularies are not available on the state-run website have been checked against the most recent National Alliance of State and Territorial AIDS Directors (NASTAD) formulary database (last updated January 1, 2022). The data presented are current as of October 20, 2022.

October 2022 Updates:

Basic Coverage

  • States with Basic HCV Medications Coverage: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OK, OR, PA, RI, SC, SD, TN, VA, WA, WV, WI, WY, D.C.

  • States without Basic HCV Medications Coverage: ID, KS, KY, MS, OH, TX, UT, VT

  • Territories with Basic HCV Medications Coverage: P.R.

Figure 1. October 2022 ADAP Coverage - Basic HCV Medications

Map Key: Yellow = Basic HCV Medication Coverage; Red = No Basic HCV Medication Coverage/No Information regarding Basic HCV Medication Coverage

Sovaldi

  • States with Sovaldi Coverage: AZ, CA, CO, GA, HI, IL, IN, IA, LA, ME, MD, MA, MN, NE, NV, NH, NJ, NM, ND, OK, OR, PA, SD, VA, WA, WI, WY, D.C.

  • States without Sovaldi Coverage: AL, AK, AR, CT, DE, FL, ID, KS, KY, MI, MS, MO, MT, NY, NC, OH, RI, SC, TN, TX, UT, VT, WV

  • Territories with Sovaldi Coverage: P.R.

Figure 2. October 2022 ADAP Coverage - Sovaldi

Map Key: Yellow = Sovaldi Coverage; Red = No Sovaldi Coverage/No Information regarding Sovaldi Coverage

Harvoni

  • States with Harvoni Coverage: AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NC, ND, OK, OR, PA, SD, TN, VA, WA, WI, WY, D.C.

  • States without Harvoni Coverage: AL, AK, KS, KY, MO, MT, NY, OH, RI, SC, TX, UT, VT, WV

  • Territories with Harvoni Coverage: P.R.

Figure 3. October 2022 ADAP Coverage - Harvoni

Map Key: Yellow = Harvoni Coverage; Red = No Harvoni Coverage/No Information regarding Harvoni Coverage

Zepatier

  • States with Zepatier Coverage: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IA, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OR, PA, SD, VA, WA, WV, WI, WY, D.C.

  • States without Zepatier Coverage: AK, CT, DE, ID, IN, KS, KY, MO, MT, OH, OK, RI, SC, TN, TX, UT, VT

  • Territories with Zepatier Coverage: P.R.

Figure 4. October 2022 ADAP Coverage - Zepatier

Map Key: Yellow = Zepatier Coverage; Red = No Zepatier Coverage/No Information regarding Zepatier Coverage

Epclusa

  • States with Epclusa Coverage: AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, NE, NY, NV, NH, NJ, NM, ND, OR, PA, SD, TN, TX, VA, WA, WI, WY

  • States without Epclusa Coverage: AL, AK, DE, KS, KY, MT, NC, OH, OK, RI, SC, UT, VT, WV, D.C.

  • Territories with Epclusa Coverage: P.R.

Figure 5. October 2022 ADAP Coverage - Epclusa

Map Key: Yellow = Epclusa Coverage; Red = No Epclusa Coverage/No Information regarding Epclusa Coverage

Vosevi

  • States with Vosevi Coverage: CA, CT, FL, HI, ID, IL, IN, IA, LA, MD, MA, MN, NE, NV, NH, NJ, NM, ND, OR, SD, TN, WA, WY

  • States without Vosevi Coverage: AL, AK, AZ, AR, CO, DE, GA, KS, KY, ME, MI, MS, MO, MT, NY, NC, OH, OK, PA, RI, SC, TX, UT, VT, VA, WV, WI, D.C.

  • Territories with Vosevi Coverage: P.R.

Figure 6. October 2022 ADAP Coverage - Vosevi

Map Key: Yellow = Vosevi Coverage; Red = No Vosevi Coverage/No Information regarding Vosevi Coverage

Mavyret

  • States with Mavyret Coverage: AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OR, PA, SD, TN, VA, WA, WV, WI, WY, D.C.

  • States without Mavyret Coverage: AK, DE, KS, KY, OH, OK, RI, SC, TX, UT, VT

  • Territories with Mavyret Coverage: P.R.

Figure 7. October 2022 ADAP Coverage - Mavyret

Map Key: Yellow = Mavyret Coverage; Red = No Mavyret Coverage/No Information regarding Mavyret Coverage

Pegasys

  • States with Pegasys Coverage: AL, CA, CO, CT, DE, HI, IL, IA, LA, ME, MD, MA, MI, MN, NE, NV, NH, NJ, NM, NC, ND, OR, PA, RI, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Pegasys Coverage: AK, AZ, AR, FL, GA, ID, IN, KS, KY, MS, MO, MT, NY, OH, OK, SC, TN, TX, UT, VT, VA

  • Territories with Pegasys Coverage: None/Unknown

Figure 8. October 2022 ADAP Coverage - Pegasys

Map Key: Yellow = Pegasys Coverage; Red = No Pegasys Coverage/No Information regarding Pegasys Coverage

Harvoni (generic)

  • States with Harvoni (generic) Coverage: AZ, AR, CA, CO, CT, FL, IL, IA, ME, MD, MA, MN, MS, NE, NV, NH, NJ, NM, NC, ND, OK, OR, PA, SD, TN, WA, WI, WY, D.C.

  • States without Harvoni (generic)Coverage: AL, AK, DE, GA, HI, ID, IN, KS, KY, LA, MI, MO, MT, NY, OH, RI, SC, TX, UT, VT, VA, WV

  • Territories with Harvoni (generic) Coverage: P.R.

Figure 9. October 2022 ADAP Coverage - Harvoni (Generic)

Map Key: Yellow = Harvoni (Generic) Coverage; Red = No Harvoni (Generic) Coverage/No Information regarding Harvoni (Generic) Coverage

Epclusa (generic)

  • States with Epclusa (generic) Coverage: AZ, AR, CA, CO, CT, FL, IL, IN, IA, ME, MD, MA, MN, MS, MO, NE, NV, NH, NJ, NM, ND, OR, PA, SD, TN, WA, WI, WY, D.C.

  • States without Epclusa (generic) Coverage: AL, AK, DE, GA, HI, ID, KS, KY, LA, MI, MT, NY, NC, OH, OK, RI, SC, TX, UT, VT, VA, WV

  • Territories with Epclusa (generic) Coverage: P.R.

Figure 10. October 2022 ADAP Coverage - Epclusa (generic)

Map Key: Yellow = Epclusa (generic) Coverage; Red = No Epclusa (generic) Coverage/No Information regarding Epclusa (generic) Coverage

October 2022 Notes:

  • States with Open Formularies: IL, IA, MA, MN, NE, NH, NJ, NM, ND, OH, OR, WA, WY

    • N.B. – Although Ohio is listed by NASTAD as having an open formulary, both NASTAD’s ADAP Formulary Database and Ohio’s ADAP website indicates that the state does not offer any treatment for HCV.

    • N.B. – Although North Dakota has adopted an open formulary, they provide only co-pay and deductible assistance for HCV medications.

    • N.B. – Wyoming's ADAP Open Formulary document, the following disclaimer related to HCV is made: Hepatitis C treatment medications (i.e. Harvoni, Sovaldi, Ribavirin, Zepatier, Epclusa) must be prior authorized. To be eligible, clients must have applied for prior authorization from their insurance plan and the WY ADAP Hepatitis C Treatment checklist must be completed and signed by the provider and client.

  • Colorado offers five coverage options – Standard ADAP, HIV Medical Assistance Program (HMAP), Bridging the Gap Colorado (BTGC), HIV Insurance Assistance Program (HIAP), and Supplemental Wrap Around Program (SWAP). ‘Yes’ indications in Figure 1. for Colorado denote that at least one of these programs offers coverage for each respective drug. The Standard ADAP Formulary covers medications only if funds are available to do so.

  • Louisiana’s ADAP (Louisiana Health Access Program – LA HAP) offers two coverage options – Uninsured (Louisiana Drug Assistance Program – L-DAP) and Insured (Health Insurance Program – HIP). HIP pays for the cost of treatment only if the client’s primary insurance covers the drug under its formulary.

  • Georgia’s ADAP notes the following: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.”

  • Texas ADAP’s coverage of HCV medications is limited to Epclusa (brand).

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3. MEDICAID PROGRAMS & HCV THERAPIES

All 50 states and the District of Columbia continue to offer some form of HCV coverage. All 50 states and the District of Columbia have expanded their Preferred Drug Lists to include at least one HCV Direct Acting Agent (DAA).

October 2022 Updates:

Basic Coverage

  • States with Basic HCV Medications Coverage: AZ, AK, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, D.C.

  • States without Basic HCV Medications Coverage: AL, ID, KS, MO, OK, SC, VA, WY

Figure 11. October 2022 Medicaid Coverage - Basic HCV Medications

Map Key: Blue = Basic HCV Medication Coverage; Yellow = No Basic HCV Medication Coverage/No Information regarding Basic HCV Medication Coverage

Sovaldi

  • States with Sovaldi Coverage: AR, CA, CO, DE, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Sovaldi Coverage: AL, AK, AZ, CT, FL, IA, NM, OR, SC, VA

Figure 12. October 2022 Medicaid Coverage - Sovaldi

Map Key: Blue = Sovaldi Coverage; Yellow = No Sovaldi Coverage/No Information regarding Sovaldi Coverage

Harvoni

  • States with Harvoni Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Harvoni Coverage: AK, AZ, CT, FL, IA, NM, OR, SC, VA

Figure 13. October 2022 Medicaid Coverage - Harvoni

Map Key: Blue = Harvoni Coverage; Yellow = No Harvoni Coverage/No Information regarding Harvoni Coverage

Zepatier

  • States with Zepatier Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Zepatier Coverage: AK, AZ, CT, FL, IA, NM, OK, OR, SC, VA

Figure 14. October 2022 Medicaid Coverage - Zepatier

Map Key: Blue = Zepatier Coverage; Yellow = No Zepatier Coverage/No Information regarding Zepatier Coverage

Epclusa

  • States with Epclusa Coverage: AL, AR, CA, CO, DE, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Epclusa Coverage: AK, AZ, CT, FL, ID, IA, MD, NE, OK, SC, VA

Figure 15. October 2022 Medicaid Coverage - Epclusa

Map Key: Blue = Epclusa Coverage; Yellow = No Epclusa Coverage/No Information regarding Epclusa Coverage

Vosevi

  • States with Vosevi Coverage: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.

  • States without Vosevi Coverage: AL, AK, AZ, NM, OK, VA

Figure 16. October 2022 Medicaid Coverage - Vosevi

Map Key: Blue = Vosevi Coverage; Yellow = No Vosevi Coverage/No Information regarding Vosevi Coverage

Mavyret

  • States with Mavyret Coverage: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

Figure 17. October 2022 Medicaid Coverage - Mavyret

Map Key: Blue = Mavyret Coverage; Yellow = No Mavyret Coverage/No Information regarding Mavyret Coverage

Pegasys

  • States with Pegasys Coverage: AK, AZ, CA, CT DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, RI, SD, TN, TX, VT, WA, WV, WI, D.C.

  • States without Pegasys Coverage: AL, AR, CO, ID, KS, MO, ND, OK, SC, UT, VA, WY

Figure 18. October 2022 Medicaid Coverage - Pegasys

Map Key: Blue = Pegasys Coverage; Yellow = No Pegasys Coverage/No Information regarding Pegasys Coverage

Harvoni (generic)

  • States with Harvoni (generic) Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, D.C.

  • States without Harvoni (generic) Coverage: AK, AZ, CT, FL, IA, KS, NM, OR, SC, VA, WY

Figure 19. October 2022 Medicaid Coverage - Harvoni (generic)

Map Key: Blue = Harvoni (generic) Coverage; Yellow = No Harvoni (generic) Coverage/No Information regarding Harvoni (generic) Coverage

Epclusa (generic)

  • States with Epclusa (generic) Coverage: AK, AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Epclusa (generic) Coverage: ID, OK

Figure 20. October 2022 Medicaid Coverage - Epclusa (generic)

Map Key: Blue = Epclusa (generic) Coverage; Yellow = No Epclusa (generic) Coverage/No Information regarding Epclusa (generic) Coverage

October 2022 Notes:

  • The follow states’ Medicaid programs offer multiple coverage plans for their respective Medicaid clients. The plan highlighted in bold typeface represents the most comprehensive plan with the most drugs covered in the respective state:

    • Hawaii – (1.) Advantage Plus; (2.) QUEST Integration

    • New Jersey – (1.) Aetna; (2.) AmeriGroup NJ; (3.) Horizon NJ Health; (4.) UnitedHealthcare of New Jersey; (5.) WellCare

    • New Mexico – (1.) BlueCross BlueShield of New Mexico; (2.) Presbyterian Centennial Care; (3) Western Sky Community Care

    • Kentucky has a Unified Medicaid Formulary

    • Louisiana has a Unified Medicaid Formulary

    • Ohio – Ohio has a Unified Medicaid Formulary that applies to all MCOs

  • Alaska Medicaid has added coverage of Epclusa (generic).

  • Delaware has added coverage of Epclusa (brand).

  • Idaho Medicaid has removed coverage of basic HCV medications.

  • Iowa Medicaid has reduced its HCV DAA coverage to only Mavyret and Epclusa (generic).

  • Maine Medicaid has added coverage of Epclusa (generic).

  • Ohio Medicaid has added coverage of Epclusa (generic).

  • Virginia Medicaid has reduced its HCV coverage to only Mavyret and Epclusa (generic).

  • No data is has been made available by the Medicaid programs in the U.S. Territories.

*Medicaid coverage excludes patients from most drug manufacturer patient assistance programs (PAPs)

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4. VETERANS PROGRAMS & HCV THERAPIES

The Veteran's Administration (VA) currently offers coverage for all HCV drugs. This is according to the most recent VA National Formulary, dated May 2021 (U.S. Dept. of V.A., 2021a). The VA Treatment Considerations and Choice of Regimen for HCV-Mono-Infected and HIV/HCV Co-Infected Patients, dated March 2021 (U.S. Dept. of V.A., 2021b) lists the following therapies as preferred treatments:

Abbreviations:

- CTP – Child-Turcotte-Pugh (score used to assess severity of cirrhosis)
- IU/mL – International Units Per Milliliter
- PEG-IFN/IFN – Peginterferon/Interferon
- RAS – Resistance-associated substitutions

Genotype 1:

  • Treatment-naïve without or with cirrhosis (CTP A):

    • Pangenotypic regimens

      • Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks in patients with poor prognostic factors

      • Epclusa: 1 tablet orally daily for 12 weeks

    • Non-pangenotypic regimens:

      • Zepatier: 1 tablet orally daily for 12 weeks if GT1a without baseline NS5A RAS or GT1b

      • Harvoni: 1 tablet orally daily

        • If HCV-noninfected, non-cirrhotic, and HCV RNA baseline <6 million IU/mL: 8 weeks

        • If cirrhotic, baseline HCV RNA ≥6 million IU/mL, HIV/HCV-co-infected, or African American: 12 weeks

        • Consider adding ribavirin in CTP A patients

  • Treatment-naïve with decompensated cirrhosis (CTP B or C):

    • Harvoni: 1 tablet orally daily + ribavirin (600 mg/day and increase by 200 mg/day every 2 weeks only as tolerated) for 12 weeks

    • Epclusa: 1 tablet orally daily + ribavirin (1000 mg/day - <75kg – or 1,200 mg daily - ≥75kg – orally daily in 2 divided doses with food) for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb).

  • Treatment-experienced (NS5A- and SOF-naïve [e.g., failed PEG-IFN/RBV ± NS3/4A PI]) without or with cirrhosis (CTP A)

    • Pangenotypic regimens:

      • Mavyret: 3 tablets orally daily with food

        • If PEG-IFN/RBV-experienced: 8 weeks if non-cirrhotic or 12 weeks if cirrhotic

        • If NS3/4A PI + PEG-IFN/RBV-experienced: 12 weeks

      • Vosevi: 1 tablet orally daily for 12 weeks

    • Non-pangenotypic regimens

      • Zepatier: 1 tablet orally daily for 12 weeks if GT1b, or if failed only PEG-IFN/RBV and GT1a without baseline NS5A RAS

      • Harvoni: 1 tablet orally daily for 12 weeks

  • Treatment-experienced (NS5A-naïve and SOF-experienced) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food

      • If PEG-IFN/RBV + Sovaldi-experienced: 8 weeks if non-cirrhotic or 12 weeks if cirrhotic

      • If Olysio + Sovaldi-experienced: 12 weeks

    • Epclusa: 1 tablet orally daily for 12 weeks if GT1b

    • Vosevi: 1 tablet orally daily with food for 12 weeks if GT1a

  • Treatment-experienced (prior NS5A-containing regimen) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 16 weeks if failed only an NS5A inhibitor without NS3/4A PI (e.g., Harvoni)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

  • Treatment-experienced with decompensated cirrhosis (CTP B or C)

    • Epclusa: 1 tablet orally daily + RBV; start at lower RBV doses as clinically indicated (e.g., baseline Hgb);

      • If NS5A-naïve: 12 weeks

      • If NS5A-experienced: 24 weeks; NOT FDA approved for 24 weeks

Genotype 2:

  • Treatment-naïve or treatment-experienced (PEG-IFN/IFN ± RBV or Sovaldi + RBV ± PEG-IFN) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 8 weeks; 12 weeks if CTP A and treatment-experienced or in patients with poor prognostic factors

    • Epclusa: 1 tablet orally daily for 12 weeks

  • Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

  • Treatment-naïve or treatment-experienced patients with decompensated cirrhosis (CTP B or CTP C)

    • Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

  • If NS5A-naïve: 12 weeks

  • If NS5A-experienced: 24 weeks

Genotype 3:

  • Treatment-naïve without cirrhosis or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks if cirrhotic or in patients with poor prognostic factors

    • Epclusa: 1 tablet orally daily for 12 weeks

      • If CTP A, test for NS5A RAS

      • Add ribavirin if Y93H RAS present

  • Treatment-experienced (PEG-IFN ± RBV or Sovaldi + RBV ± PEG-IFN) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 16 weeks

  • Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

      • If CTP A, consider adding ribavirin (no supporting data)

  • Treatment-naïve or treatment-experienced with decompensated cirrhosis (CTP B or CTP C)

    • Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

      • If NS5A-naïve: 12 weeks

      • If NS5A-experienced: 24 weeks

Genotype 4:

  • Treatment-naïve without or with cirrhosis (CTP A)

    • Pangenotypic regimens

      • Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks in patients with poor prognostic factors

      • Epclusa: 1 tablet orally daily for 12 weeks

    • Non-pangenotypic regimens

      • Zepatier: 1 tablet orally daily for 12 weeks

      • Harvoni: 1 tablet orally daily for 12 weeks

  • Treatment-naïve with decompensated cirrhosis (CTP B or C)

    • Pangenotypic regimen

      • Epclusa: 1 tablet orally daily + RBV for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

    • Non-pangenotypic regimen:

      • Harvoni: 1 tablet orally daily + ribavirin (600 mg/day and increase by 200 mg/day every 2 weeks only as tolerated) for 12 weeks

  • Treatment-experienced (Sovaldi-experienced and NS5A-naïve) without or with cirrhosis (CTP A)

    • Mavyret: 3 tablets orally daily with food for 8 weeks if NS3/4A PI-naïve without cirrhosis, and 12 weeks if NS3/4A PI-experienced or CTP A

    • Epclusa: 1 tablet orally daily + ribavirin for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

  • Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)

    • Vosevi: 1 tablet orally daily with food for 12 weeks

  • Treatment-experienced with decompensated cirrhosis (CTP B or CTP C)

    • Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)

      • If NS5A-naïve: 12 weeks

      • If NS5A-experienced: 24 weeks; NOT FDA approved for 24 weeks

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5. PATIENT ASSISTANCE PROGRAMS

The drug manufacturers and various national nonprofit organizations offer a variation of patient assistance programs (PAPs) to assist patients in accessing treatments. They include:

Support Path (Gilead Sciences):

  • Financial Assistance

    • Provides Co-Pay Coupons for Sovaldi, Harvoni, Harvoni (Generic), Epclusa, Epclusa (Generic), and Vosevi

    • Co-Pay Coupons cover out-of-pocket costs up to 25% of the catalog price of a 12-week regimen (3 bottles/packages) of Sovaldi, Harvoni, Harvoni (Generic), Epclusa, Epclusa (Generic), or Vosevi

    • Excludes patients enrolled in Medicare Part D or Medicaid

  • Insurance Support

    • Researches and verifies patient’s benefits, and gives information they need about coverage options and policies

    • Explain Prior Authorization process and works with HCV Specialist’s office so they can submit PA forms to a patient’s insurance company

    • May be able to provide assistance with appeals process

  • Website: http://www.mysupportpath.com/

AbbVie Mavyret Co-Pay Savings Card:

  • Financial Assistance

    • Patient may be eligible to pay as little as $5

    • Excludes patients enrolled in Medicare Part D, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs)

  • Website: https://www.mavyret.com/copay-savings-card

NeedyMeds:

  • NeedyMeds Drug Discount Card

    • Designed to lower cost of prescription medications by up to 80% at participating pharmacies

    • Price finder tool for the drug discount card

    • No eligibility requirements

    • CANNOT be used in combination with government healthcare programs, but CAN be used IN PLACE of program

    • CANNOT be combined with other offers

  • Website: http://ow.ly/fEJo309cJ7Z

The Assistance Fund:

  • Status: WAITLISTED

  • Requires provider referral

  • Copay assistance

  • Eligibility Criteria:

    • US citizen or permanent resident

    • Diagnosed with the disease for which you are applying

    • Prescribed an FDA-approved treatment for the disease

    • Have prescription coverage for the prescribed treatment

    • Meet financial eligibility criteria based upon household income and size

  • Website: https://tafcares.org/patients/covered-diseases/

Patient Advocate Foundation Co-Pay Relief:

  • Status: CLOSED

  • Maximum award of $15,000

  • Eligibility Requirements:

    • Patient must be insured, and insurance must cover prescribed medication

    • Confirmed HCV diagnosis

    • Reside and receive treatment in the U.S.

    • Income falls below 400% of FPL with consideration of the Cost of Living Index (COLI) and the number in the household

  • Website: https://www.copays.org/diseases/hepatitis-c

Patient Access Network (PAN) Foundation:

HealthWell Foundation:

  • Status: OPEN

  • Co-Pay Assistance with a maximum award of $30,000

  • Minimum Co-Pay Reimbursement Amount: None

  • Minimum Premium Reimbursement Amount: None

  • Eligibility Requirements:

    • Must be being treated for HCV

    • Have insurance that covers HCV prescribed medication

    • Income falls below 500% of FPL

    • Receiving treatment in the U.S.

  • Website: https://www.healthwellfoundation.org/fund/hepatitis-c/

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6. HARM REDUCTION PROGRAMS

Harm Reduction, as it relates to opioid abuse and HCV, are measures designed to serve as preventive or monitoring efforts in combating opioid prescription drug and heroin abuse, and as an effect, helping to prevent the spread of HCV and HIV. The Co-Infection Watch covers the following measures: Syringe Exchange, Expanded Naloxone Access, Good Samaritan Laws, Mandatory PDMP Reporting, Doctor Shopping Laws, Physical Exam Requirements, ID Requirements for Purchase, Required or Recommended Prescriber Education, and Lock-In Programs (Editor’s Note: Program descriptions provided herein).

October 2022 Updates:

Syringe Exchange

Syringe Services Programs (SSPs) exist to provide injection drug users (or those whose prescriptions require injection) with clean syringes and/or in exchange for used ones. (N.b. – states listed as "at least one SSP…” indicate only that a Syringe Services Program (SSP) exists within the state, regardless of the legality of SSPs under state law).

  • States with Syringe Exchange: AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, D.C.

  • States without Syringe Exchange: AL, KS, MS, NE, SD, WY

  • Territories with Syringe Exchange: Puerto Rico, U.S. Virgin Islands

Figure 21. October 2022 Syringe Exchange Coverage

Map Key: Purple = Syringe Exchange(s); Red = No Syringe Exchange(s); Grey = No Information

Expanded Naloxone

Naloxone is a drug used to counteract the effects of opioid overdoses. Expanded Access refers to one of more of the following conditions: Naloxone purchase without a prescription; availability to schools, hospitals, and emergency response units for use in the event of an overdose.

  • States with Expanded Naloxone: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Expanded Naloxone: None

  • Territories with Expanded Naloxone: Unknown

Figure 22. October 2022 Expanded Naloxone Coverage

Map Key: Purple = Expanded Naloxone; Red = Restricted Naloxone; Gray = No Information

Good Samaritan Laws

Good Samaritan Laws are laws that are designed to protect emergency services personnel, public or private employees, and/or citizens from being held legally liable for any negative healthcare outcomes as a result of providing "reasonable measures" of emergent care.

  • States with Samaritan Laws: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Samaritan Laws: None

  • Territories with Samaritan Laws: Unknown

Figure 23. October 2022 Good Samaritan Laws Coverage

Map Key: Purple = Good Samaritan Laws; Red = No Good Samaritan Laws; Gray: No Information

Mandatory PDMP Reporting

Prescription Drug Monitoring Programs (PDMPs) are programs established by state and/or federal law that requires prescribing physicians and the fulfilling pharmacies to report to a state agency one or more of the following data points: Patient Names; Specific Drug(s) Prescribed; Prescription Dosage; Date; Time; Form of State-Issued ID.

  • States with PDMP Reporting: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without PDMP Reporting: MO, MT, SD

  • Territories with PDMP Reporting: Guam

Figure 24. October 2022 Mandatory Prescription Drug Monitoring Program Coverage

Map Key: Purple = Mandatory PDMP; Red = No Mandatory PDMP; Gray = No Information

Doctor Shopping Laws

Doctor Shopping Laws are those laws designed to prevent patients from seeking one or more of the same prescription from multiple doctors through the use of subterfuge, falsifying identity, or any other deceptive means. While federal law prohibits Doctor Shopping, most states also include provisions that prohibit patients from seeking a new prescription if another physician has denied a similar prescription within a certain period of time.

  • States with Doctor Shopping Laws: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Doctor Shopping Laws: None

  • Territories with Doctor Shopping Laws: None

Figure 25. October 2022 Doctor Shopping Laws Coverage

Map Key: Purple = Doctor Shopping Laws; Red = No Doctor Shopping Laws; Grey = No Information

Physical Exam Required

Physical Exam Requirements are those that mandate that the prescribing physician perform a physical examination on a patient before providing a prescription for a controlled substance to determine if the prescription is medically necessary.

  • States with Physical Exam Required: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MO, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY, D.C.

  • States without Physical Exam Required: KS, MT, OR, SD, WI

  • Territories with Physical Exam Required: None

Figure 26. October 2022 Physical Exam Required Coverage

Map Key: Purple = Physical Exam Required; Red: No Physical Exam Required; Grey = No Information

I.D. Required for Purchase of Opioid Prescription

Federal law requires anyone purchase a controlled substance to provide a state-issued identification (“I.D.”) in order to fill the prescription. Mandatory ID requirements go further and require that this information be recorded and stored in an effort to prevent the same patient from obtaining multiple or repeated prescriptions in a given period of time.

  • States with I.D. Required: AZ, CA, CT, DE, FL, GA, HI, ID, IL, IN, KY, LA, ME, MA, MI, MS, MN, MT, NE, NV, NJ, NM, NY, NC, ND, OK, OR, SC, TN, TX, VT, VA, WV, WI, WY

  • States without I.D. Required: AL, AK, AR, CO, IA, KS, MD, MO, NH, OH, PA, RI, SD, UT, WA, D.C.

  • Territories with I.D. Required: Unknown

Figure 27. October 2022 I.D. Required Coverage

Map Key: Purple = I.D. Required; Red = No I.D. Required; Gray = No Information

Prescriber Education Required/Recommended

States that require/do not require that prescribing physicians undergo special training related to safer prescribing and utilization practices.

  • States with Prescriber Education Required: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Prescriber Education Required: KS, MO, MT, ND, SD

  • Territories with Prescriber Education Required: Unknown

Figure 28. October 2022 Prescriber Education Required Coverage

Map Key: Purple = Prescriber Ed Required; Red = No Prescriber Ed Required; Gray = No Information

Medicaid Lock-In Program

Lock-In Programs are laws requiring that patients either receive prescriptions from only one physician and/or fill prescriptions from only one pharmacy.

  • States with Medicaid Lock-In Program: AL, AK, AZ, AR, CA, CO, CT, DE, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.

  • States without Medicaid Lock-In Program: FL, HI, SD

  • Territories with Medicaid Lock-In Program: Unknown

Figure 29. October 2022 Medicaid Lock-In Coverage

Map Key: Purple = Medicaid Lock-In; Red = No Medicaid Lock-In; Gray = No Information

October 2022 Notes:

  • No updates from the previous report published in July 2022.

  • CANN is no longer able to independently verify the existence of an SSP in Kansas. KS state laws prohibit SSPs and syringes are included in the state’s drug paraphernalia law.

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7. COVID-19 IMPACT ON HIV & HCV

The Community Access National Network’s blog began 2021 by assessing COVID-19’s impact on HIV, HCV, and Substance-Use Disorder. We've subsequently followed-up by asking, COVID-19: How Far We’ve Come & How Far We Have to Go? We continue to monitor developments in light of the ongoing COVID-19 pandemic and its impacts on public health.

Additional Resources and Relevant Issues:

  • Declaration of Public Health Emergency Renewed - On October 13, 2022, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the existing declaration of a public health emergency (PHE) due to COVID-19. The previous declaration was set to expire in January 2023. To review some potential changes when the PHE ends, click here.

  • COVID-19 Vaccine, Booster Highly Effective for PLWHA - Published in October 2022, two large studies showed people living with HIV/AIDS (PLWHA) who are also vaccinated for COVID-19 have a low risk of serious illness or death and both studies show a booster provided even more protection. The studies, performed in the United States and Denmark, were done in mid-2021 and during a period when Omicron variants became dominant in much the world, respectively.

  • HIV Researcher in Cleveland Sees Health Similarities in Long-term HIV Survivors and Long-COVID - Dr. Grace McComsey’s research into long-term COVID-19 impacts on a body is given a local review. Citing her knowledge and work in HIV, Dr. McComsey finds certain similarities in terms of the body’s responses (namely, inflammation) between HIV and those suffering from “long” COVID, or a broad range of symptoms about 30% of patients have reported after a COVID-19 infection. Comparing her experiencing is leading some of the frames of her research into finding treatments for long COVID, Dr. McComsey describes how inflammation leads to increased rates of heart disease and cancers and how she’s using her HIV knowledge to investigate treatments for patients experiencing long COVID.

  • Opinion: Stand with Public Health - The Des Moines Register published an opinion piece pinned by Dr. James Merchant, former U.S Centers for Disease Control and Prevention Director of Respiratory Disease Studies. Opening the piece by sharing how President George W. Bush was recently awarded the Hoover Humanitarian Award for establishing the President’s Emergency Plan for AIDS Relief (PEPFAR), Dr. Merchant also quotes President Bush on his assessment of what’s needed to effectively combat COVID-19 and other infectious diseases and health disparities: “Get the politics out of public health.”

  • HIV rates re-surging in Mississippi, Louisiana - After disruptions in HIV testing, linkage to care, retention in care, and diversion of HIV staffing in order to address the COVID-19 crisis phase of 2020, both states had either issued a Health Advisory Notice or received recent news coverage due to increases in new HIV diagnoses which surpass previous years’ metrics, threatening the United States’ goal of Ending the HIV Epidemic.

  • Study: Greater Morality and Disease Severity in Patients with Hepatitis B and COVID-19 - While numerous studies have been done to show adverse health outcomes for people diagnosed with COVID-19 and having other co-occurring conditions, a new meta-analysis shows specifically that patients with COVID-19 and Hepatitis B (HBV) infections are more likely to experience negative health outcomes and mortality. The analysis found 2,591 patients co-diagnosed and 35,105 with only a COVID diagnosis. After eliminating duplicates and other disqualifying information, the analysis zeroed in on 12 studies. The findings of the analysis include exceptionally high liver function abnormalities and significantly more likelihood of developing severe COVID illness.

  • Leveraging Lessons Learned from the COVID-19 Pandemic for HIV - Much has been made of how HIV expertise was leveraged to provide a rapid, though incomplete, response to the COVID-19 pandemic. A recent Lancet article reviews what HIV could learn or at least better leverage from the COVID-19 pandemic in order to effectively end the HIV pandemic (yes, HIV is still a pandemic). Highlighting investments in basic science and vaccine technology, authors also discuss how government collaboration and funding, including public-private partnerships, provided exceptional responses and investment in public health and pharmaceutical and non-pharmaceutical interventions. These interventions also specifically targeted underserved communities and focused resources to these highly affected communities in order to effectively mount a response to a rapidly developing situation.

  • COVID-19 Vaccination Exposes Latent HIV in Lab Studies - Researchers led by a team at Weill Cornell Medicine have published findings that SARS-COV-2 mRNA vaccines uncovered HIV “hiding” in cells in the blood of people living with HIV/AIDS (PLWHA). One of the long-held obstacles in eliminating HIV in a body has been how the virus “hides” away from medications and cells adapted to attacking HIV which would otherwise help eliminate the virus. Previous study has found annual flu shots sometimes have a similar effect, though it was unclear if this effect was limited to flu specific T-cells or not. Identifying ways to “wake-up” these reservoirs, or latency reversal, would help research identify more potent medications or even a cure for HIV.

  • Misinformation is a Common Thread Between COVID-19 and HIV/AIDS Pandemics - with Deadly Consequences - From denying the mere existence of a pathogen to down placing its threat, misinformation hasn’t changed much from the AIDS crisis to the COVID-19 crisis phase. These conspiracy theories (lab experiments and miracle cures) necessarily harm the public health response by peddling intentionally vague claims and sometime even outright lies in order to further the political or economic aspirations of the person speaking (or writing) them. Author Cristian Apetrei urges readers to consider public health strategies that take into account the nature of misinformation and how to combat it from the get go and to incorporate those strategies into long-term planning and preparedness.

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8. LATEST NEWS

  • Renewal of Determination That a Public Health Emergency Exists - On September 29, 2022, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the ongoing declaration of public health emergency regarding the opioid crisis. The declaration is the latest in extensions regarding the opioid crisis, originating in October 2017.

  • CANN Launches Monkeypox (MPV) Response Project for People Living with HIV - The Community Access National Network (CANN) has launched a project designed to provide a national, state-by-state, patient-facing resource on policies, programs, activities, and news regarding the United States' response to the Monkeypox (MPV) outbreak that began in May 2022. The project primarily aims to help patients living with HIV understand, engage, and advocate on matters of public health being influenced by MPV in the United States. Because poorly executed and delayed public health programs are poised for MPV to become endemic in the United States and is disproportionately impacting people living with HIV, a consolidated resource which reflects a patient's ability to navigate these complex systems is necessary. Recognizing both strengths and weaknesses across public health programs empowers patients to self-advocate for efficient and effective policies and programs, a lesson well learned in HIV advocacy. The project is generously supported by Gilead Sciences.

  • It Takes Money to End the HIV Epidemic Among Black Women - Despite advancements in reaching HIV testing and care goals among white, cisgender gay men, large disparities remain for Black Women (both cisgender and transgender). These disparities are found in both the health outcomes monitored for public health initiatives and in the funding focused at reaching Black Women as a highly affected cohort. Limited or no programming focused on meeting these communities where they live or addressing stigma within these communities has resulted in many of these women feeling HIV doesn’t or wouldn’t affect them - that, or the subject is so taboo, it isn’t mentioned. ViiV Healthcare has infused $8 million in funding, specifically granted to community based organizations which are geared toward and run by Black Women, to help change that narrative and hopefully the outcomes.

  • Prioritizing Culturally Competent Care, Advocacy, and Access in HIV - During a symposium presented at IDWeek2022 (a conference, Infectious Disease Week 2022), Dr. Marwan Haddad stated an emphasis was needed to be extended beyond medication developments “but also [to] what fires we as a medical community need to put out.” Dr. Haddad implored attendees to consider their role in advocacy, opposing harmful legislation and policies and activating as an influential voice on behalf of patients. Stating plainly, “Our patients…are affected by…these culture wars which will lead to increased stigma and discrimination in all states, which will result in more HIV infections, worsening mental health, higher rates of suicidal ideation, and worse health outcomes.

  • White House Outlines Plan to Help Pregnant People with Substance Use Disorder - The Biden Administration issued a report earlier this month detailing how challenging it is for pregnant people to access assistance in substance use recovery. The report addresses issues ranging from finding providers to prescribe medication assisted treatment to how children are often removed from the care of their birthing parent and put in foster care systems, arguably the most predominant problem for families struggling with substance use disorder and a determinant of a person’s willingness to engage with medical providers. The report outlines several steps, key funding initiatives, and the goals of the program.

  • Culture: Leslie Jordan’s Long History of HIV/AIDS Advocacy - On Monday, October 24th, the incomparable Leslie Jordan died. An actor and comedian known for his short stature and flamboyant openness as a southern, gay man, Jordan was driven by his own lived experience attending friends and loved ones dying during the height of the AIDS Crisis. In past interviews, the actor referred to himself as “too talkative” to do work like delivering meals. Instead, he took his time sharing social space with those who needed connection even as the world abandoned them. Continuing his advocacy as recently as being the Grand Marshall at the Nashville AIDS Walk, these stories shaped his own…Walk Down the Pink Carpet.

  • Georgia Implements Mandatory HBV, HCV Screening During Pregnancy - The Georgia Department of Public Health (DPH) began the process of mandating Hepatitis B (HBV) and Hepatitis C (HCV) screening for pregnant people in 2019, after the state’s viral surveillance showed the state averages 248 HBV-exposed births per year and, between 2018-2021, 667 births to persons with HCCV RNA reactive lab tests within one year of birth. The proposed rulemaking was slowed due to the COVID-19 pandemic crisis phase in 2020 and 2021. A quick reference guide can be viewed here.

  • Study: Three-Dose regimen of HEPLISAV-B Vaccine Fully Protects PLWHA - A study was presented at IDWEEK2022, finding that three doses of HEPLISAV-B vaccine achieved protective levels of immunological responses in people living with HIV/AIDS (PLWHA), a group that had not previously studied with regard to this vaccine. The FDA approved HEPLISAV-B in 2017 as a two dose regimen for adults, generally. Study participants had no evidence of prior Hepatitis B vaccination or infection.

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9. CONTACT

Jen Laws, President & CEO

jen@tiicann.org

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10. REFERENCES

Available upon request.

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Jen Laws, President & CEO

Jen Laws (Pronouns: He/Him/His) is the President & Founder of Policy Candy, LLC, which is a non-partisan health policy analysis firm specializing in various aspects of health care and public health policy, focusing on the needs of the HIV-affected and Transgender communities. In that capacity, Jen has served as the President & CEO of the Community Access National Network (CANN), beginning in January 2022. He previously served as the Project Director of CANN's HIV/HCV Co-Infection Watch, as well as 340B Policy Consultant.

Jen began his advocacy efforts in Philadelphia in 2005, at the age of 19, coordinating team efforts for a corporation participating in the AIDS Walk. His connection to HIV advocacy grew when partnering with Mr. Friendly, a leading anti-HIV-stigma campaign.

He began working in public health policy in 2013, as a subcontractor for Broward Regional Planning Council evaluating Marketplace plans for plan year 2014, advising and educating constituents on plan selection. Jen was a member of South Florida AIDS Network and has worked with Florida Department of Health, Broward and Miami-Dade County Health Departments, Pride Center South Florida, and other local organizations to South Florida in addressing the concerns and needs of these intersecting communities. During this time, Jen was seated on the board of directors for the ADAP Advocacy Association.

Having moved to the New Orleans area in 2019, Jen resumed his community-based advocacy as the chair of Louisiana's Ending the HIV Epidemic planning subcommittee for Data-based Policy and Advocacy, regular participation as a community member and "do-gooder" with other governmental and non-governmental planning bodies across the Louisiana, and engages with other southern state planning bodies. He continues his advocacy in governmental health care policy evaluation, which has been utilized to expand access to quality healthcare by working with RAD Remedy to deliver the nation's foremost database of trans* competent health care providers. Lending his expertise on policy matters ranging from 340B impact on RW providers and patients to strategic communications and data analysis, Jen's approach to community engagement is focused on being accessible across all stakeholder groups and centering the perspectives of PLWHA and Transgender people. He is a community ambassador alumni of the CDC's Let's Stop HIV Together campaign.

In his personal life, Jen enjoys spending his time being "ridiculously wholesome" with his partner, Aisha, and her two amazing daughters. In their personal time, when not immersed in crafts or house projects, they can be found seeking opportunities to help their neighbors, friends, and community members (who have come to rightfully expect exquisite gift baskets of Aisha's homemade jams and jellies from time to time). Jen strives to set a good example both in his personal professional life of integrating values into action and extending the kindness and care that have led him to a life he calls "extraordinarily lucky".

https://tiicann.org
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Watch 01: January 2023

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Watch 03: July 2022