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The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir+RBV+PEG 12 weeks | Experimental | Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. |
|
| Sofosbuvir+RBV 12 weeks | Experimental | Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks. |
|
| Sofosbuvir+RBV 16 weeks | Experimental | Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks. |
|
| Sofosbuvir+RBV 24 Weeks | Experimental | Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With On-Treatment Virologic Failure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26503414 | Result | Lai CL, Wong VW, Yuen MF, Yang JC, Knox SJ, Mo H, Han LL, Brainard DM, Chan HL. Sofosbuvir plus ribavirin for the treatment of patients with chronic genotype 1 or 6 hepatitis C virus infection in Hong Kong. Aliment Pharmacol Ther. 2016 Jan;43(1):96-101. doi: 10.1111/apt.13429. Epub 2015 Oct 26. | |
| 26864153 | Result |
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815 participants were screened.
Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+PEG+RBV 12 Weeks | Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
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| PEG | Drug | Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week |
|
|
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment. |
| Up to 24 weeks |
| Percentage of Participants With Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. | Up to Posttreatment Week 24 |
| Change From Baseline in HCV RNA (log10 IU/mL) | Up to 24 weeks |
| Chongqing |
| China |
| Fujian | China |
| Guangdong | China |
| Guangxi | China |
| Hainan | China |
| Hebei | China |
| Hubei | China |
| Hunan | China |
| Jiangxi | China |
| Jilin City | China |
| Jin’an | China |
| Liaoyang | China |
| Shanghai | China |
| Sichuan | China |
| Yunnan | China |
| Zhejiang | China |
| Hong Kong | Hong Kong |
| Shatin | Hong Kong |
| Incheon | Gyeonggi-do | South Korea |
| Seongnam-si | Gyeonggi-do | South Korea |
| Ansan-si | South Korea |
| Bucheon-si | South Korea |
| Busan | South Korea |
| Daegu | South Korea |
| Seoul | South Korea |
| Chang-hua | Taiwan |
| Kaohsiung City | Taiwan |
| Keelung | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| Hanoi | Vietnam |
| Ho Chi Minh City | Vietnam |
| Ahn SH, Lim YS, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Mathias A, Han L, Knox SJ, Brainard DM, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus. J Viral Hepat. 2016 May;23(5):358-65. doi: 10.1111/jvh.12499. Epub 2016 Feb 10. |
| 26835876 | Result | Kao JH, Chien RN, Chang TT, Peng CY, Hu TH, Lo GH, Wang HY, Chen JJ, Yang JC, Knox SJ, Han L, Mo H, Mathias A, Brainard DM, Sheen IS, Hsu YC, Chu CJ, Chuang WL. A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection. Liver Int. 2016 Aug;36(8):1101-7. doi: 10.1111/liv.13082. Epub 2016 Mar 23. |
| SOF+RBV 12 Weeks |
Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| FG002 | SOF+RBV 16 Weeks | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks |
| FG003 | SOF+RBV 24 Weeks | Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who were enrolled and received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| BG001 | SOF+RBV 12 Weeks (GT1 and GT6) | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| BG002 | SOF+RBV 16 Weeks (GT1 and GT6) | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks |
| BG003 | SOF+RBV 24 Weeks (GT1 and GT6) | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
| BG004 | SOF+RBV 12 Weeks (GT2) | Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| BG005 | SOF+RBV 24 Weeks (GT3) | Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HCV Genotype | Count of Participants | Participants |
| ||||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. | Full Analysis Set: participants who enrolled in the study and received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Count of Participants | Participants | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-Treatment Virologic Failure | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment. | Full Analysis Set | Posted | Count of Participants | Participants | Up to 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. | Full Analysis Set | Posted | Count of Participants | Participants | Up to Posttreatment Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA (log10 IU/mL) | Participants in the Full Analysis Set with available data were analyzed | Posted | Mean | Standard Deviation | log10 IU/mL | Up to 24 weeks |
|
Up to 24 Weeks Plus 30 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SOF+PEG+RBV 12 Weeks | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 5 | 155 | 145 | 155 | ||
| EG001 | SOF+RBV 12 Weeks | Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 7 | 290 | 215 | 290 | ||
| EG002 | SOF+RBV 16 Weeks | Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 0 | 11 | 5 | 11 | ||
| EG003 | SOF+RBV 24 Weeks | Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks | 4 | 230 | 177 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angle closure glaucoma | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
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| Hepatic lesion | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Back injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Cerebellar infarction | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Reticulocyte count increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Not Disclosed |
|
| Hong Kong |
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| South Korea |
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| Taiwan |
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| Vietnam |
|
| Genotype 2 |
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| Genotype 3 |
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| Genotype 6 |
|
| CT |
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| TT |
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| ≥ 800,000 IU/mL |
|
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Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
| OG004 | SOF+RBV 12 Weeks (GT2) | Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| OG005 | SOF+RBV 24 Weeks (GT3) | Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
|
|
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
| OG004 | SOF+RBV 12 Weeks (GT2) | Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| OG005 | SOF+RBV 24 Weeks (GT3) | Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
|
|
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
| OG004 | SOF+RBV 12 Weeks (GT2) | Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| OG005 | SOF+RBV 24 Weeks (GT3) | Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
|
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| OG004 | SOF+RBV 12 Weeks (GT2) | Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| OG005 | SOF+RBV 24 Weeks (GT3) | Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks |
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