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Investigational

Tenofovir (microbicide)  Audio icon

Other Names: GS-1278, PMPA gel, TFV gel, tenofovir 1% gel, tenofovir gel
Drug Class: Microbicides
Molecular Formula: C9 H14 N5 O4 P
Registry Number: 147127-20-6 (CAS)
Chemical Name: [(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methylphosphonic acid
Chemical Class: Purine Nucleotides
Company: Gilead Sciences, Inc.
Phase of Development: Phase III (Tenofovir vaginal gel is in Phase III testing. Other tenofovir-based microbicide products are in Phase I and II studies.)
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Chemical Image:
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tenofovir
tenofovir
Molecular Weight: 287.2146
(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 and ClinicalTrials.gov3-7)
Patent Version Content

Pharmacology


Mechanism of Action: Microbicide; nucleoside reverse transcriptase inhibitor. HIV-specific topical microbicides formulated with ARV drugs, such as tenofovir, are being developed as a pre-exposure prophylaxis (PrEP) strategy to prevent the sexual transmission of HIV. ARV-based topical microbicides are designed to inhibit the infection process at the vaginal or rectal mucosa and directly interfere with the HIV replication cycle.8-11

Tenofovir, an adenosine nucleoside monophosphate (nucleotide) analog, is intracellularly phosphorylated to the active metabolite tenofovir diphosphate (TFV-DP). TFV-DP competitively inhibits the activity of HIV reverse transcriptase and causes DNA chain termination.10,12 Tenofovir, formulated as a microbicide, has primarily been studied for preventing sexually transmitted HIV; secondarily, it has been studied for its potential impact on preventing other sexually transmitted infections, such as HSV-2.3

A pharmacokinetic study compared daily dosing of tenofovir vaginal gel with daily dosing of tenofovir disoproxil fumarate (TDF) oral tablets. When compared to the oral daily dosing regimen, daily dosing of the vaginal gel resulted in vaginal tissue TFV-DP concentrations that were more than 100-fold higher and systemic tenofovir exposures that were 56-fold lower.13

In a study of rectally applied tenofovir gel versus oral TDF, tenofovir plasma concentrations were 24- to 33-fold lower after a single application of the gel than after a single oral dose. Rectal tissue concentrations of both tenofovir and TFV-DP were 2-4 log10 higher after single rectal dosing than after single oral dosing.14

Half-life (T½): Following a single oral dose, the plasma elimination half-life of tenofovir is approximately 17 hours, while the intracellular half-life is greater than 60 hours.10 In a study that compared rectally applied tenofovir gel to oral TDF, the tenofovir plasma half-life was noted to be at least 5 hours shorter with single and multiple rectal dosing than with single oral dosing.14

Metabolism/Elimination: Tenofovir is not a substrate of CYP enzymes. Following intravenous (IV) administration of tenofovir, approximately 70 to 80% of the dose is recovered in the urine as unchanged drug. Tenofovir is eliminated renally.10

Resistance: In a Phase IIb study (CAPRISA 004) of tenofovir 1% vaginal gel, no tenofovir-related resistance mutations, thymidine analog mutations (TAMs), or mutations conferring multi-NRTI resistance were detected among HIV seroconverters. (HIV seroconverters were exposed to tenofovir gel for approximately 3 to 4 weeks after infection, and resistance testing was performed approximately 20 weeks after the date of infection.)15

In the VOICE trial, which assessed the effectiveness of a topical HIV prevention method (tenofovir 1% vaginal gel) and two different oral HIV prevention methods (TDF and emtricitabine/TDF), one participant in the emtricitabine/TDF group who underwent HIV-1 seroconversion 11 months after enrollment developed the M184V HIV resistance mutation.16

In the context of suboptimal use of microbicides, an in vitro study examined the effects of suboptimal concentrations of tenofovir, dapivirine, and dapivirine in combination with tenofovir on the development of drug-resistant HIV over 25 weeks. Results indicated that suboptimal doses of dapivirine alone permitted the emergence of more reverse transcriptase mutations than did the suboptimal doses of dapivirine in combination with tenofovir or the suboptimal doses of tenofovir alone. Suboptimal concentrations of tenofovir alone resulted in the development of one NRTI mutation, K65R.17


Clinical Trials


Reduced Glycerin Tenofovir 1% Gel (Intrarectal):

Study Identifiers: MTN-017; NCT01687218
Phase: II
Study Purpose: Study to evaluate the safety and acceptability of reduced glycerin tenofovir 1% gel applied rectally versus oral emtricitabine/TDF (Truvada)
Study Population: HIV-uninfected men and transgender women
Dosing: Participants were randomized to one of six groups. Groups differed by the order in which each study product was used. All participants received the following study products for 8 weeks each, with a 1-week washout between products:
  • Reduced glycerin tenofovir 1% gel applied rectally and once daily
  • Reduced glycerin tenofovir 1% gel applied rectally, used within 12 hours prior to receptive anal intercourse (RAI) and as soon as possible within 12 hours after RAI; no more than two doses used in a 24-hour period (dosing strategy also known as BAT24)
  • Truvada (200 mg emtricitabine/300 mg TDF) taken orally and once daily.4,18-20
Selected Study Results:
  • CROI, 2016: MTN-017: Rectal Phase 2 Extended Safety and Acceptability Study of 1% Tenofovir Gel
  • MTN news release, Feb 2016: International Study Finds Rectal Microbicide Gel Safe When Used Daily and With Sex


  • Tenofovir 1% Gel (Intravaginal):

    Study Identifiers: CAPRISA 004; NCT00441298
    Phase: IIb
    Study Purpose: Study to assess the safety and effectiveness of tenofovir 1% vaginal gel for preventing HIV infection in women
    Study Population: HIV-uninfected women in South Africa
    Dosing: Tenofovir 1% gel (vaginal formulation) used within 12 hours prior to intercourse and as soon as possible within 12 hours after intercourse; no more than two doses used in a 24-hour period (dosing strategy also known as BAT24); or placebo used in the same manner.15,21-24

    * An open-label extension study (CAPRISA 008) has also been completed. CAPRISA 008 provided previous CAPRISA 004 participants with tenofovir gel. The study assessed product safety and the effectiveness of an implementation model for gel provision through family planning services.25,26

    Selected Study Results:

    Study Identifiers: MTN-003; VOICE trial; NCT00705679
    Phase: IIb
    Study Purpose: Study to assess the safety and effectiveness of oral TDF (Viread), oral emtricitabine/TDF (Truvada), and tenofovir 1% vaginal gel for the prevention of HIV infection in women
    Study Population: HIV-uninfected women in South Africa, Uganda, and Zimbabwe
    Dosing: Participants were randomized to one of the following five groups:

    • TDF 300 mg plus Truvada placebo, both taken orally and once daily
    • Truvada (200 mg emtricitabine/300 mg TDF) plus TDF placebo, both taken orally and once daily
    • TDF placebo plus Truvada placebo, both taken orally and once daily
    • Tenofovir 1% gel (vaginal formulation) applied once daily
    • Vaginal placebo gel applied once daily.16,27-29
    Selected Study Results:

    Study Identifiers: FACTS 001; NCT01386294
    Phase: III
    Study Purpose: Study to assess the safety and effectiveness of tenofovir 1% vaginal gel for preventing HIV infection and HSV-2 infection in women
    Study Population: HIV-uninfected women in South Africa
    Dosing: Tenofovir 1% gel (vaginal formulation) used within 12 hours prior to intercourse and as soon as possible within 12 hours after intercourse; no more than two doses used in a 24-hour period (dosing strategy also known as BAT24); or placebo used in the same manner.3,30,31
    Selected Study Results:



    Additional clinical trials of tenofovir 1% vaginal or rectal gels have been completed or are ongoing or planned. One example is the Phase I MTN-007 study, which tested the safety and acceptability of reduced glycerin tenofovir 1% gel for rectal use. Another example is the Phase I CHARM-01 and CHARM-02 studies, which evaluated the safety, acceptability, and pharmacokinetics of three gel formulations used rectally: a vaginal formulation, a reduced glycerin vaginal formulation, and a rectal-specific formulation.32-37 Other forms of tenofovir-based microbicides in early development include vaginal tablets, vaginal films, and intravaginal rings.5-7,38-41


    Adverse Events


    In the MTN-017 study, which compared rectally applied reduced glycerin tenofovir 1% gel with oral emtricitabine/TDF, the gel was reported to be safe, with the majority of adverse events (AEs) being minor. Grade 2 or higher AE rates in the gel groups were similar to the rates in the oral emtricitabine/TDF group.19,20

    In the CAPRISA 004 study, tenofovir 1% vaginal gel that was used over a 30-month period by women demonstrated no evidence of increased renal, hepatic, pregnancy-related, or genital AEs when compared with placebo. Mild and self-limiting diarrhea was reported more frequently in the tenofovir gel group than in the placebo group.15

    In the VOICE trial, elevations in serum creatinine levels (all mild, except one) occurred more frequently among participants in the oral Truvada group than among participants in the oral placebo group. No other significant differences in safety concerns were noted in the study.16


    Drug Interactions


    Drug interactions related to topical tenofovir gel are currently unknown. An in vivo drug interaction study of tenofovir 1% vaginal gel and three commonly used vaginal products was completed.42


    References


    1. United States National Library of Medicine. ChemIDplus Advanced. Available at: http://chem.sis.nlm.nih.gov/chemidplus/rn/147127-20-6. Last accessed on April 5, 2016.
    2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Available at: http://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Last accessed on April 5, 2016.
    3. CONRAD. A Phase III, Multi-Centre, Randomized Controlled Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel in the Prevention of Human Immunodeficiency Virus Type 1 Infection in Women, and to Examine Effects of the Microbicide on the Incidence of Herpes Simplex Virus Type 2 Infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 28, 2011. NLM Identifier: NCT01386294. Available at: https://www.clinicaltrials.gov/ct2/show/NCT01386294. Last accessed on April 5, 2016.
    4. CONRAD. A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 27, 2012. NLM Identifier: NCT01687218. Available at: https://www.clinicaltrials.gov/ct2/show/NCT01687218. Last accessed on April 5, 2016.
    5. CONRAD. A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 5, 2013. NLM Identifier: NCT01989663. Available at: https://www.clinicaltrials.gov/ct2/show/NCT01989663. Last accessed on April 5, 2016.
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    7. Albert Einstein College of Medicine of Yeshiva University. Phase 1 Safety and Pharmacokinetic Study of Polyurethane Tenofovir Disoproxil Fumarate Vaginal Ring. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 19, 2013. NLM Identifier: NCT02006264. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02006264. Last accessed on April 5, 2016.
    8. Shattock RJ, Rosenberg Z. Microbicides: Topical Prevention against HIV. Cold Spring Harb Perspect Med. 2012 Feb;2(2):a007385. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3281595/. Last accessed on April 5, 2016.
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    Last Reviewed: April 5, 2016

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