Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year, Prospective, Real-World Study in France.

Abstract

BACKGROUND AND AIMS:

Tenofovir disoproxil fumarate (TDF) demonstrated potent and sustainable antiviral efficacy and a good safety profile in patients with chronic hepatitis B (CHB) in controlled clinical trials. Real-world data are important to confirm effectiveness and safety data in patient populations encountered in routine clinical practice.

METHODS:

This non-interventional, prospective, 36-month study included treatment-naïve and treatment-experienced patients with CHB initiating their first TDF regimen (monotherapy or combination therapy) in routine clinical practice in France. Clinical, virologic, biochemical, compliance, and safety data were collected.

RESULTS:

Data from 440 consecutive patients from 58 centers were analyzed. The majority of the cohort was male (71 %), hepatitis B "e" antigen-negative (HBeAg-) (74 %), and treatment-experienced (56 %); 11 % were aged ≥65 years; and comorbidities were reported in 39 %. After 12 months, 92 % of the overall cohort achieved virologic response (HBV DNA <69 IU/mL) which was maintained to 36 months (96 %); virologic response was achieved by >90 % of patients irrespective of HBeAg status, age, or prior treatment history. At 36 months, 77 % of patients had normal alanine aminotransferase levels. Fourteen patients lost hepatis B surface (HBs) antigen, and seven seroconverted to anti-HBs. TDF was well tolerated over the 36-month study, including in 14 women who became pregnant during the study. Median estimated glomerular filtration rate did not change markedly from baseline irrespective of prior treatment history.

CONCLUSIONS:

TDF demonstrated potent virologic and biochemical responses across a broad range of patients reflective of routine clinical practice. The safety profile was consistent with results from pivotal trials.

• Authors: Patrick Marcellin, Fabien Zoulim, Christophe Hézode, Xavier Causse, Bruno Roche, Régine Truchi, Arnaud Pauwels, Denis Ouzan, Jérôme Dumortier, Georges-Philippe Pageaux, Marc Bourlière, Ghassan Riachi, Jean-Pierre Zarski, Jean-François Cadranel, Valérie Tilliet, Christiane Stern, Pascal Pétour, Olivier Libert, Silla M Consoli, Dominique Larrey
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 61 Issue 10 Pg. 3072-3083 (10 2016) ISSN: 1573-2568 [Electronic] United States
• PMID: 26821154 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Tenofovir

Topics

• Abdominal Pain (chemically induced)
• Adult
• Aged
• Antiviral Agents (therapeutic use)
• Asthenia (chemically induced)
• DNA, Viral (blood)
• Diarrhea (chemically induced)
• Female
• France
• Headache (chemically induced)
• Hepatitis B Surface Antigens (blood)
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (blood, drug therapy)
• Humans
• Hypophosphatemia (chemically induced)
• Kidney Diseases (chemically induced)
• Kidney Function Tests
• Male
• Middle Aged
• Nausea (chemically induced)
• Prospective Studies
• Seroconversion
• Tenofovir (therapeutic use)
• Treatment Outcome
• Viral Load
• Vomiting (chemically induced)