Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

Prior treatment

• Receipt of treatment for HCV within 24 weeks prior to study entry
• Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage)
• Malignancy within 5 years prior to study entry. NOTE: A history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary.
• Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry

Other illness

• History of HCC or cholangiocarcinoma
• History of solid organ transplantation
• History of uveitis or posterior synechiae

Other

• Evidence of advanced fibrosis or cirrhosis (Metavir ≥F3 or equivalent).
• Breastfeeding

• HIV-1 infection
• Effective antiviral therapy for HIV (ART) and HBV that includes TDF, TAF, TDF/FTC, TDF/3TC (tenofovir disoproxil fumarate plus lamivudine), TAF/FTC, or entecavir (ETV), for ≥5 years immediately prior to study entry. ART is defined as including a minimum of two anti-HIV antivirals.
• CD4+ cell count ≥350 cells/mm3
• HIV-1 RNA \<50 copies/mL measured on at least two occasions at least 12 weeks apart, with no documented value \>200 copies/mL, over the 12 months prior to study entry.
• Positive or negative HBeAg
• Negative anti-HDV
• Current CHB infection
• HBV DNA level \<50 IU/mL measured on at least two occasions at least 12 weeks apart, with no documented value ≥50 IU/mL, over the 12 months prior to study entry.
• Quantitative HBsAg \>1000 IU/mL
• Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
• Participants age ≥18 years and ≤70 years at study entry
• Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.